Iranian Registry Of Clinical Trials Research Articles

Design and evaluation of a colon cancer mobile application

BackgroundColorectal cancer (CRC) is the third leading cause of cancer and the second cause of cancer-related deaths in the world. Despite the infrastructure and the availability of organized screening programs, participation in their screening programs is less than the set goals. Considering the importance of informing the society about the prevention and early detection of colorectal cancer symptoms and the positive impact of mobile health technologies, the present research was conducted with the aim of designing and evaluating a colon cancer mobile application.MethodsThe present research was conducted in two phases: software design and evaluation. In the first phase, the software was prepared using the cascade method. First, all the educational content related to colorectal cancer was collected through an expert panel with the participation of 10 specialists. Then the software was evaluated with alpha and beta testing, and the initial version was approved by users in terms of simplicity and usability. In the second phase, a parallel clinical randomized trial study was conducted with the aim of investigating the effect of a colon cancer mobile application on the early detection of colorectal cancer. In this stage, 204 volunteers participated; inclusion criteria were age 18–85 years, owning a smartphone and the ability to read and write. Participants were randomized into control and intervention groups. The intervention group was educated with the colon cancer application for education about colorectal cancer, and the control group was educated with a pamphlet. After education, both groups were screened for colorectal cancer symptoms, and the results were compared.ResultsIn the software evaluation phase, the application was used by 204 users. In this stage, 84 (41.2%) women and 120 (58.8%) men, with an average (Standard Deviation) age of 47.53 (13.68) participated. Participants were randomized in two groups, 103 people with an average (Standard Deviation) age of 47.62 (14.65) in intervention group and 101 people with an average (Standard Deviation) age of 47.44 (12.70) in control group. There were no significant differences between the demographic characteristics of age, gender, marriage, occupation, instruction level, digestive disease history, cancer history, cancer risk factors, and family history of cancer between the two groups (P > 0.05). The Mann-Whitney U test indicated that there is a significant difference between the two groups of participants in self-assessment, willingness to do the screening, and the results of the assessment of colorectal cancer (P < 0.05).ConclusionThe results of the research indicated the positive impact of the Colon Cancer Application on the abilities of the users of self-assessment of colon cancer. Therefore, based on the findings, it can be concluded that the use of the colon cancer mobile application is effective for colon cancer prevention and self-care.Trial registrationThis study was registered in the Iranian Registry of Clinical Trials (https://irct.behdasht.gov.ir) on 13/2/2024, with the IRCT ID: IRCT20210131050189N9.

Nasal profile changes after LeFort I osteotomy (maxillary advancement) with and without ANS reduction in class III skeletal patients: a study protocol for a randomized clinical trial

BackgroundDentofacial malformation is a common condition that affects a significant portion of the population, resulting in functional and aesthetic defects. Orthognathic surgeries, such as LeFort I osteotomy, are performed to correct these abnormalities. However, the impact of these surgeries on nasal profile changes remains unclear. Additionally, the role of anterior nasal spine (ANS) reduction in maxillary advancement surgeries of 3–5 mm range is yet to be determined. This study aims to investigate the effect of ANS reduction on soft tissue profile changes following LeFort I osteotomy with a maxillary advancement range of 3–5 mm in class III skeletal patients. The hypothesis is that the changes in nasolabial angle and upper lip length will not significantly differ between patients who undergo LeFort I osteotomy with and without ANS reduction.Method and designThis study is designed as a randomized controlled trial. A total of 26 class III skeletal patients with maxillofacial abnormalities will be recruited from the maxillofacial clinic of Bu-Ali and Farahikhtegan Hospitals in Tehran, Iran. Patients meeting the inclusion criteria will be randomly assigned to two groups: one group will undergo LeFort I osteotomy with ANS reduction, and the other group will undergo LeFort I osteotomy without ANS reduction. The soft tissue profile changes, specifically the nasolabial angle and upper lip length, will be evaluated and compared between the two groups.DiscussionAchieving facial harmony through orthognathic surgery requires careful planning and consideration of the impact on surrounding soft tissue. The primary objective is to predict and plan for the effects on the nasolabial region. LeFort I osteotomy is a common procedure used to correct dentofacial deformities, particularly in class III patients. Maxillary advancement during this surgery can lead to changes in nasal tip position, width, and rotation, potentially due to repositioning of the anterior nasal spine and soft tissue dissection. In this study, soft tissue changes will be assessed in non-growing class III patients using cephalometric radiographs. The impact of reducing the anterior nasal spine (ANS) on nasal profile changes will be investigated for maxillary advancements of 3–5 mm. Objective measurements and patient-reported outcomes will be evaluated to gain insights into the aesthetic outcomes of orthognathic surgery. The findings will provide valuable guidance for treatment decisions and alternative options based on expected nasal profile changes.Trial registrationThis project was registered at The Iranian Registry of Clinical Trials (Identifier No. IRCT20210928052625N1, Website: https://www.irct.ir/trial/59171) and Open Science Framework (OSF) (Registration https://doi.org/10.17605/OSF.IO/X3HD4). 2021-06-09.

Effects of Satureja Khuzestanica supplementation on glycemic indices and lipid profile in type 2 diabetes patients: a randomized controlled clinical-trial

BackgroundSeveral studies showed the hypoglycemic and hypolipidemic effects of Satureja Khuzestanica (SK) in animal models. This study aimed to determine the effect of SK supplementation on glycemic and lipid outcomes of patients with type 2 diabetes mellitus (T2DM).MethodsThe study was designed as a double-blind, placebo-controlled, randomized clinical trial using block randomization. Seventy-eight T2DM patients were randomly assigned to intervention (n = 39) or placebo (n = 39) groups. They received SK or placebo in 500 mg capsules daily for 12 weeks. Anthropometric, blood pressure, liver enzymes, glycemic, and lipid outcomes were measured before and after the intervention.ResultsAt baseline, there were no significant differences in age, sex, or glycated hemoglobin (HbA1c) levels between the groups. SK supplementation led to a significant decrease in FBS (-12.6 ± 20.7 mg/dl in the intervention group versus 3.5 ± 31.9 mg/dl; p = 0.007), HbA1c (-0.28 ± 0.45 in the intervention group versus 0.11 ± 0.54% in the placebo group; p = < 0.001), insulin (-1.65 ± 6.18 in the intervention group versus 2.09 ± 5.90 mIU/L in the placebo group; p = 0.03), total cholesterol (-14.6 ± 21.1 mg/dl in the intervention group versus 8.2 ± 30.9 mg/dl in the placebo group; p < 0.001), LDL-cholesterol (-4.6 ± 15.2 mg/dl in the intervention group versus 5.8 ± 14.6 mg/dl in placebo group; p < 0.001) levels, and significant increase in HDL-cholesterol (3.9 ± 4.9 mg/dl in the intervention group versus 0.9 ± 5.2 mg/dl in placebo group; p = 0.005).ConclusionBased on the study results, SK supplementation may improve glycemic indices and lipid profile of patients with T2DM. Our findings may provide novel complementary treatments without adverse effects for diabetes complications. These results need to be further confirmed in clinical trials.Registration: This trial has been registered in the Iranian Registry of Clinical Trials (IRCT ID: IRCT20190715044214N1, registration date: 21/02/2021).

Effectiveness of two educational interventions based on the theory of planned behavior on oral cancer self-examination in adults: a randomized controlled trial.

The theory of planned behavior (TPB) is recognized as an effective theory for behavior change. The aim of the present study was to investigate the impact of two TPB-based educational interventions on oral self-examination (OSE) behavior and the related TPB constructs among adults in Tehran, Iran, in 2022. This randomized controlled trial involved 400 healthy individuals recruited from 20 urban comprehensive health centers in the southern part of Tehran, Iran. The health centers were randomly assigned to two control (PowerPoint) and intervention (WhatsApp) groups (200 individuals in each group). In the control group (the recipient of the routine care), participants received a 20-minute lecture through a PowerPoint presentation and a pamphlet. In the intervention group (the recipient of an additional intervention alongside the routine care), participants were educated through messages and images on WhatsApp along with having monthly group discussions. Data was collected at baseline, as well as at 1- and 3-month follow-ups using a structured questionnaire. The outcomes assessed included OSE behavior and the related TPB constructs: intention, attitude, subjective norm, and perceived behavioral control. Linear and logistic generalized estimating equations (GEE) regression models were used to evaluate the impact of the interventions with STATA version 17. Of the total participants, 151 (37.75%) were men. The mean ± standard deviation (SD) of ages in the PowerPoint and WhatsApp groups were 39.89 ± 13.72 and 39.45 ± 13.90, respectively. OSE and the related TPB constructs showed significant differences between the groups at the 1-month post-intervention assessment. The effect of PowerPoint was more significant in the short-term (one month), while both methods showed similar effectiveness after three months, specifically in relation to OSE and the TPB constructs. At the 3-month post-intervention assessment, there were significant increases in OSE (OR = 28.63), intention (β = 1.47), attitude (β = 0.66), subjective norm (β = 2.82), and perceived behavioral control (β = 1.19) in both groups (p < 0.001). The present study provides evidence of the effectiveness of both educational interventions in improving OSE and the TPB constructs after three months. Therefore, both TPB-based educational methods can be recommended for designing and implementing interventions aimed at preventing oral cancer. The trial protocol was registered in the Iranian Registry of Clinical Trials (IRCT) on 04/03/2022 (registration number: IRCT20220221054086N1).

Effect of nano-curcumin supplementation on angina status, and traditional and novel cardiovascular risk factors in overweight or obese patients with coronary slow flow phenomenon: a randomized double-blind placebo-controlled clinical trial

BackgroundCardiovascular events and poor quality of life are frequently observed in patients with coronary slow flow phenomenon (CSFP). This trial evaluated the effect of nano-curcumin supplement containing curcuminoids, as multifunctional nutraceuticals, on angina status, and some traditional and novel cardiovascular risk factors in overweight or obese patients with CSFP.MethodsIn this double-blind, randomized, placebo-controlled clinical trial, 42 overweight or obese patients with CSFP received either 80 mg/day of nano-curcumin or placebo for 12 weeks. Seattle angina questionnaire (SAQ) as a clinical measure of angina status, circulating endocan, adropin, homocysteine, lipid profile, and the novel scores of visceral adiposity index (VAI) and waist-triglyceride index (WTI) were assessed before and after the intervention. The independent samples t-test, Mann-Whitney test, analysis of covariance, Chi-square, and Fisher’s exact tests were used where appropriate.ResultsAll domains of SAQ including physical limitation, angina stability, angina frequency-severity, treatment satisfaction, and disease perception and quality of life improved significantly in the nano-curcumin compared with the placebo group. No significant changes were observed in serum endocan, adropin, and homocysteine following the intervention. Triglycerides, triglyceride/high-density lipoprotein cholesterol ratio, WTI and VAI values improved significantly only within the nano-curcumin group.ConclusionsSupplementation with 80 mg/day nano-curcumin (containing curcuminoids) for 12 weeks significantly improved clinically important disease-specific aspects of health in patients with CSFP. Some traditional and novel cardiovascular risk factors improved significantly only compared with the baseline values, which need further investigation.Trial registrationThis study was approved by the Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1398.794). The study protocol was registered at Iranian Registry of Clinical Trials by IRCT20131125015536N8 registration ID at 19.06.2019.

The effect of probiotic-fortified kefir on cardiovascular risk factors in elderly population: a double-blind, randomized, placebo-controlled clinical trial

IntroductionThe outbreak of cardiovascular disease (CVD) augments with age. Gut dysbiosis can worsen or initiate systemic disorders such as metabolic diseases and CVDs. Therefore, this research aimed to assess the effect of kefir fortified with Lactobacillus helveticus R0052 and Bifidobacterium longum R017 on CVD risk factors in the elderly population. The subjects of this study were selected from the Motahari Clinic in Shiraz, Iran.MethodThis study was a double-blind, randomized, and controlled clinical trial that was conducted on 67 elderly people who were randomly divided into two groups: the fortified kefir group (n = 32), which received one bottle of fortified kefir (240 cc), and the placebo group (n = 35), which received one bottle of regular kefir for eight weeks. To analyze the data, SPSS software was applied.ResultsAfter eight weeks, significant differences were seen in atherogenic and Castell’s risk index I between the fortified and regular groups (p = 0.048 and p = 0.048, respectively). No significant differences were found in Castelli’s risk index II, high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides (TG), non-HDL-C, TG-cholesterol index, and fasting blood sugar by comparing the two groups.ConclusionOur investigation demonstrated that fortified kefir with probiotics did not significantly affect lipid profiles. Still, it could significantly affect some indices, including Castelli’s risk index I and atherogenic index. More studies are required to confirm the findings and mechanisms of probiotics’ effect on CVD risk factors.Trial numberThe present registered at the Iranian Registry of Clinical Trials (IRCT20130227012628N3) at 2023-02-21.

Extended dosing (12 cycles) vs conventional dosing (6 cycles) of adjuvant temozolomide in adults with newly diagnosed high-grade gliomas: a randomized, single-blind, two-arm, parallel-group controlled trial.

Maximum safe surgical resection followed by adjuvant chemoradiation and temozolomide chemotherapy is the current standard of care in the management of newly diagnosed high grade glioma. However, there are controversies about the optimal number of adjuvant temozolomide cycles. This study aimed to compare the survival benefits of 12 cycles against 6 cycles of adjuvant temozolomide adults with newly diagnosed high grade gliomas. Adult patients with newly diagnosed high grade gliomas, and a Karnofsky performance status>60%, were randomized to receive either 6 cycles or 12 cycles of adjuvant temozolomide. Patients were followed-up for assessment of overall survival (OS) and progression-free survival (PFS) by brain MRI every 3 months within the first year after treatment and then every six months. A total of 100 patients (6 cycles, 50; 12 cycles, 50) were entered. The rate of treatment completion in 6 cycles and 12 cycles groups were 91.3% and 55.1%, respectively. With a median follow-up of 26 months, the 12-, 24-, 36-, and 48-month OS rates in 6 cycles and 12 cycles groups were 81.3% vs 78.8%, 58.3% vs 49.8%, 47.6% vs 34.1%, and 47.6% vs 31.5%, respectively (p-value=.19). Median OS of 6 cycles and 12 cycles groups were 35 months (95% confidence interval (CI), 11.0 to 58.9) and 23 months (95%CI, 16.9 to 29.0). The 12-, 24-, 36-, and 48- month PFS rates in 6 cycles and 12 cycles groups were 70.8% vs 56.9%, 39.5% and 32.7%, 27.1% vs 28.8%, and 21.1% vs 28.8%, respectively (p=.88). The Median PFS of 6 cycles and 12 cycles groups was 18 months (95% CI, 14.8 to 21.1) and 16 (95% CI, 11.0 to 20.9) months. Patients with newly diagnosed high grade gliomas treated with adjuvant temozolomide after maximum safe surgical resection and adjuvant chemoradiation do not benefit from extended adjuvant temozolomide beyond 6 cycles. Prospectively registered with the Iranian Registry of Clinical Trials: IRCT20160706028815N3. Date registered: 18/03/14.

The effect of selenium supplementation on oxidative stress, clinical and physiological symptoms in patients with migraine: a double-blinded randomized clinical trial.

The present double-blinded randomized clinical trial aimed to investigate the effect of selenium supplementation on oxidative stress, clinical, and physiological symptoms in patients with migraine. In total, 72 patients with migraine were randomly assigned to receive either 200 μg/day selenium (n = 36) or placebo (n = 36) for 12 weeks. Clinical traits of migraine (e.g., severity, frequency, and duration of headaches), mental health indices (e.g., depression, anxiety, and distress), quality of life, biomarkers of oxidative stress (e.g., nitric oxide [NO], malondialdehyde [MDA], total antioxidant capacity [TAC], total oxidant status [TOS]), and anthropometric indices were assessed at baseline and at the end of the study. Selenium supplementation resulted in a significant reduction in NO (-1.24 ± 0.43 vs. 0.16 ± 0.43; p = 0.03) levels and a significant increase in TAC (9.89 ± 2.50 vs. -0.18 ± 2.50; p = 0.01) compared to the placebo group. Moreover, selenium supplementation had a significant protective effect against MDA levels compared to placebo (0.33 ± 0.57 vs. 1.83 ± 0.57; p = 0.03). In addition, selenium intake was associated with a lower headache frequency (-8.15 ± 0.77 vs. -4.12 ± 0.77; p < 0.001) and severity (-2.89 ± 0.42 vs. -1.16 ± 0.42; p = 0.01) as well as a lower Headache Impact Test-6 (HIT-6) score (-9.22 ± 2.00 vs. -2.08 ± 2.00; p = 0.02) compared to the controls. For other outcome variables, we found no significant effect. Selenium supplement may be considered a complementary therapy in patients with migraine due to its beneficial effects on oxidative stress and migraine symptoms. Further studies are needed to affirm our findings.Clinical Trial Registration: This study was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir) on 27 May 2023 with code number of IRCT20121216011763N60.

Effect of dry needling on pain and central sensitization in women with chronic pelvic pain: A randomized parallel-group controlled clinical trial

Chronic pelvic pain (CPP) is a debilitating problem in women with clear evidence of myofascial dysfunction. It seems that Myofascial trigger points (MTrPs) contribute to the development of central sensitization (CS). This study aimed to investigate the effect of dry needling on pain and CS in women with CPP. Thirty-six women with CPP participated in this randomized controlled clinical trial and randomly assigned into three groups: dry needling group (DNG), placebo needling group (PNG) and control group (CG). The DNG received five sessions of DN using the “static needling”, the PNG received non-penetrating method, and the CG did not receive any intervention. Assessment of outcomes including central sensitization inventory (CSI), short-form McGill pain questionnaire (SF-MPQ), electroencephalography (EEG), conditioned pain modulation (CPM), salivary cortisol concentration, 7-item general anxiety disorder scale (GAD-7), pain catastrophizing scale (PCS), and SF-36 questionnaire was performed pre-intervention, post-intervention, and three months post-intervention by a blind examiner. The result showed a significant group-by-time interaction for CSI, SF-MPQ, and PCS. There was a significant decrease in CSI score in post-intervention and three-months post-intervention compare to pre-intervention in the DNG and PNG. SF-MPQ-PPI score in DNG significantly decreased post-intervention. PCS-Total score decreased significantly post-intervention in DNG and PNG. No significant group-by-time interactions were observed for other variables. EEG results showed regional changes in the activity of frequency bands in both eye closed and eye open conditions. It seems that DN can affect central pain processing by removing the source of peripheral nociception.Trial registration: Iranian Registry of Clinical Trials (IRCT20211114053057N1, registered on: December 03, 2021. https://irct.behdasht.gov.ir/search/result?query=IRCT20211114053057N1).

The effect of resilience training with mHealth application based on micro-learning method on the stress and anxiety of nurses working in intensive care units: a randomized controlled trial

IntroductionNurses in intensive care units (ICUs) face high stress and anxiety, impacting their well-being and productivity. Addressing this, this study evaluated the impact of resilience training via a mHealth application based on micro-learning on ICU nurses’ stress and anxiety levels.Materials and methodsThis study, a single-blind randomized controlled trial conducted in 2022-23, involved sixty ICU nurses from two Tehran hospitals. Nurses were chosen through purposive sampling and divided into intervention and control groups by simple randomization. The intervention group was taught resilience via an educational mHealth application based on micro-learning, with data collected using the anxiety and stress subscales of DASS-21.ResultsBefore the intervention, there were no significant differences in stress and anxiety scores between the intervention and control groups (P > 0.05). Upon utilizing the mHealth application, the intervention group exhibited significant reductions in stress, from 10.77 ± 3.33 to 9.00 ± 1.66 (P = 0.001), and in anxiety, from 9.43 ± 3.35 to 7.93 ± 0.98 (P < 0.001). In contrast, the control group experienced a slight increase in stress levels, from 10.10 ± 2.19 to 10.73 ± 2.15 (P = 0.002), and in anxiety levels, from 9.10 ± 1.63 to 10.23 ± 1.65 (P < 0.0001).ConclusionsThe micro-learning-based mHealth application for resilience training significantly reduced ICU nurses’ stress and anxiety, recommending its adoption as an innovative educational method.Trial registrationThe study has been registered in the Iranian Registry of Clinical Trials (No. IRCT20221225056916N1, Date: 04/29/2023).

A randomized clinical trial investigating the impact of magnesium supplementation on clinical and biochemical measures in COVID-19 patients

BackgroundThis study sought to examine the impact of magnesium supplementation on clinical outcomes and biochemical factors among hospitalized patients with COVID-19.MethodsThis double-blind, randomized clinical trial was conducted at Razi Hospital, Ahvaz, Iran, between September 2021 and March 2022. Participants aged 18–70 years with moderate disease severity were enrolled. Magnesium supplementation (300 mg daily) was administered to the intervention group, while the control group received a placebo. Clinical outcomes, including the need for oxygen therapy, oxygen saturation, respiratory rate, fever, hs-CRP and TNF-α levels, as well as quality of life and mental health, were assessed. Blood samples were collected to measure biochemical variables.ResultsThe main result was the count of individuals requiring oxygen therapy. Additional outcomes comprised of oxygen saturation, respiratory rate, fever, hs-CRP and TNF-α levels, as well as quality of life and mental health. Out of 64 participants, 60 completed the study. The results showed that magnesium supplementation significantly reduced the number of patients requiring oxygen therapy (9 vs. 14; P < 0.001). Moreover, the magnesium group demonstrated improved oxygen saturation compared to the control group (4.55 ± 2.35 vs. 1.8 ± 1.67; P < 0.001). Furthermore, we observed a noteworthy enhancement in the quality of life and depression score in the magnesium group. No significant differences were observed in respiratory rate, fever, hs-CRP, and TNF-α levels (P > 0.05).ConclusionThe findings suggest that magnesium supplementation may have beneficial effects on clinical outcomes and arterial oxygen saturation in COVID-19 patients. More investigation is necessary to delve into its potential mechanisms and long-term effects on patient outcomes.Trial registrationThis study is registered on Iranian Registry of Clinical Trials (IRCT) under identifier IRCT20210413050957N1. (The registration date: May 1, 2021).

The comparison of the effect of non-pharmacological pain relief and pharmacological analgesia with remifentanil on fear of childbirth and postpartum depression: a randomized controlled clinical trial

IntroductionChildbirth may be associated with psychological, social, and emotional effects and provide the background for women’s health or illness throughout their life. This research aimed at comparing the impact of non-pharmacological pain relief and pharmacological analgesia with remifentanil on childbirth fear and postpartum depression.Materials and methodThis randomized clinical trial with two parallel arms was conducted on 66 women with term pregnancy referred to Taleghani Hospital in Tabriz for vaginal delivery during September 2022 to September 2023. First, all of the eligible participants were selected through Convenience Sampling. Then, they were randomly assigned into two groups of pharmacological analgesia with remifentanil and non-pharmacological analgesia with a ratio of 1:1 using stratified block randomization based on the number of births. Before the intervention, fear of childbirth (FOC) was measured using Delivery Fear Scale (DFS) between 4 and 6 cm cervical dilatation. Pain and fear during labor in dilatation of 8 cm were measured in both groups using VAS and DFS. After delivery, FOC was assessed using Delivery Fear Scale (W DEQ Version B) and postpartum depression using the Edinburgh’s postpartum depression scale (EPDS). Significance level was considered 0.05. Mean difference (MD) was compared with Independent T-test and ANCOVA pre and post intervention.ResultsThe mean score of FOC in the non-pharmacological analgesia group was significantly lower than that in the pharmacological analgesia group after the intervention by controlling the effect of the baseline score (MD: -6.33, 95%, Confidence Interval (CI): -12.79 to -0.12, p = 0.04). In the postpartum period, the mean score of FOC in the non-pharmacological analgesia group was significantly lower than that in the pharmacological analgesia group after controlling the effect of the baseline score (MD: -21.89; 95% CI: -35.12 to -8.66; p = 0.002). The mean score of postpartum depression in the non-pharmacological analgesia group was significantly lower than that in the pharmacological analgesia group (MD: -1.93, 95% CI: -3.48 to -0.37, p = 0.01). Trial registration: Iranian Registry of Clinical Trials (IRCT): IRCT20170506033834N10. Date of registration: 05/07/2022 Date of first registration: 05/07/2022. URL: https://www.irct.ir/trial/61030; Date of recruitment start date05/07/2022.ConclusionThe study results indicated a reduction in FOC and postpartum depression among parturient women receiving non-pharmacological strategies with active participation in childbirth compared to women receiving pharmacological analgesia. Owing to the possible side effects of pharmacological methods for mother and fetus, non-pharmacological strategies with active participation of the mother in childbirth are recommended to reduce the FOC and postpartum depression.

Comparison of therapeutic effects of N-Acetylcysteine with pregabalin in improving the clinical symptoms of painful diabetic neuropathy: a randomized, double-blind clinical trial

ObjectivesPainful diabetic neuropathy (PDN) is highly prevalent and annoyingly in patients with diabetes. The aim of this study was to investigate the effects of oral N-acetylcysteine (NAC) compared to pregabalin in PDN.MethodsOne hundred two eligible patients with type 2 diabetes and PDN were randomly recievied pregabalin (150 mg/day) or N-Acetylcysteine (NAC) (600 mg/ twice a day) for 8 weeks. Mean pain score, Sleep interference score (SIS), Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), and also, serum levels of total antioxidant capacity (TAC), total thiol groups (TTG), catalase activity (CAT), nitric oxide (NO), and malondialdehyde (MDA) were assessed at baseline and at the end of the study.ResultsNAC was well tolerated in all patients. The decrease in mean pain scores and increase in SIS was similar between two groups. More improvement in PGIC and CGIC from the baseline was reported in NAC group. NAC, significantly, decreased serum levels of MDA, and NO, but increased TAC, TTG, and CAT. Pregabalin, significantly, decreased serum levels of MDA, and NO and increased TAC.DiscussionNAC is efficacious in alleviate symptoms of PDN which is probably related to its antioxidant effects.Trial registrationThe research protocol received approval from the Ethics Committee of Hamadan University of Medical Sciences (IR.UMSHA.REC.1397.137). The trial registry URL and number in Iranian Registry of Clinical Trials (IRCT): https://www.irct.ir/trial/33313, IRCT20180814040795N2 (Registration date: 2019-01-21, Retrospectively registered)

The effect of ascending- descending ultrafiltration and sodium profiles on blood pressure in hemodialysis patients: a randomized cross-over study

BackgroundConsidering no previous research into the utilization of ascending/descending ultrafiltration and linear sodium profiles in improving blood pressure among hemodialysis patients, the present study aimed to explore the effect of the A/D-UF along with linear sodium profiles on HD patients with hypotension.MethodsApplying a crossover design, this clinical trial was fulfilled between December 2022 and June 2023 on 20 patients undergoing HD, randomized into two groups, each one receiving two intervention protocols, viz., (a) an intervention protocol in which the liquid sodium in the dialysis solution was linear and the UF profiling was A/D, and (b) a routine protocol or HD, wherein both liquid sodium and UF in the dialysis solution remained constant. The HD patients’ BP was then checked and recorded at six intervals, namely, before HD, one, two, three, and four hours after it, and following its completion, within each session. The data were further statistically analyzed using the IBM SPSS Statistics 20 and the related tests.ResultsIn total, 20 patients, including 12 men (60%) and 8 women (40%), with the mean age of 58.00 ± 14.54 on HD for an average of 54 months, were recruited in this study. No statistically significant difference was observed in the mean systolic and diastolic BP levels in the group receiving the A/D-UF profile all through the desired hours (p > 0.05), indicating that the patients did not face many changes in these two numbers during HD. Our cross-over clinical trial demonstrated a statistically significant reduction in symptomatic IDH episodes from 55 to 15% with the application of the A/D-UF profile (p < 0.05).ConclusionThe study demonstrated that the A/D-UF profile could contribute to the stability of blood pressure levels among HD patients, with no significant fluctuations observed during treatment sessions.Trial RegistrationThis study was registered in the Iranian Registry of Clinical Trials (no. IRCT20180429039463N5) on 07/01/2023.

The effect of aqueous extract of Iranian oak (Quercus brantii) on antioxidant capacity and oxidative stress in beta-thalassemia patients: Randomized controlled trial

Background and AimFrequent administration of blood in β- thalassemia patients can lead to over-loaded iron, a reduction in the levels of antioxidant activities in the body, and oxidative stress. This study was done to evaluate the antioxidant and protective effect of aqueous oak (Quercus brantii) extract supplementation on these patients. MethodsThis clinical trial was performed on 60 major β thalassemia patients dividing them into intervention and control groups. In addition to taking desferrioxamine (DFO), the control and intervention groups received respectively placebo capsule supplementation and aqueous Quercus extract capsules (300 mg/day) for 3 months. Serum lipid profiles (LDL-c, HDL-c, triglyceride), Total Antioxidant Capacity (TAC), Glucose, Uric acid, urea nitrogen (BUN), Creatinine, LFT (Liver Function Tests) such as SGOT, SGPT, ALP, Total bilirubin, Direct bilirubin, ferritin, MDA and carbonyl protein (CO) levels were measured before and after the period. In addition, the activity of catalase (CAT), and superoxide dismutase (SOD) was measured in the red blood cell. Furthermore, antioxidant activity and total phenolic content of aqueous Quercus were recorded to standardize capsule formulation. ResultsMean serum MDA, and protein CO, significantly decreased in the intervention group with β-TM after 3 months of treatment with Quercus extract. In addition, the superoxide dismutase (SOD) enzyme and Total antioxidant capacity (TAC) significantly increased in comparison with the control group. Changes in serum creatinine, BUN, and alanine transferase were not significant. In the study, Quercus extract capsules contain 48/56 mg gallic acid / g (dry extract) total phenol, 58/6 mg / g (dry extract), and flavonoids of 63/8 μg/ml antioxidant power which by GC/MS analysis has been measured. At the end of the study, serum MDA decreased from 48.65 ± 8.74 to 43.94 ± 10.39 μ mol/l after administration of oak extract and protein CO dropped from 2.44 ± 0.38 to 1.2 ± 0.31 nmol DNPH/mg protein after administration of the oak extract. At the end of the study serum, TAC increased in patients interventional group from 907 ± 319 to 977 ± 327μmol FeSO4/l compared to the control group 916 ± 275 to 905.233 ± 233 μmol FeSO4/l with placebo, and SOD increased from 1577 ±325 to 2079 ±554 U/l (compared to 1687 ± 323 U/l with placebo). The treatment effect of Quercus was measured using a mixed-effects model of variance analysis for changes in MDA, protein CO, TAC, and SOD, with significant effects being demonstrated for each laboratory parameter (P=0.15, P=0.001, P=0.02, and P < 0.003, respectively). ConclusionsAqueous Quercus extract, due to its high antioxidant potential, reduced MDA, serum carbonyl protein, and increased superoxide dismutase activity effectively decreased serum OS and enhanced serum antioxidant capacity in patients with β-thalassemia major. oak given as an adjuvant therapy to standard iron chelators may provide an improvement in the OS measurements obtained in these patients. Registration informationThis study was submitted, evaluated, and approved by the Iranian Registry of Clinical Trials (IRCT: http://www.irct.ir; IRCT2015101411819N4), which was established for national medical schools in Iran.

A comparative study on prophylactic efficacy of cinnarizine and amitriptyline in childhood migraine: a randomized double-blind clinical trial.

Pediatric migraine prophylaxis is indicated when headaches are frequent and/or disabling. We aimed to conduct a study to compare the efficacy of cinnarizine and amitriptyline in pediatric migraine prophylaxis. In a randomized, double-blind trial, patients aged 4-17 years with migraine who were eligible for prophylaxis enrolled. The primary outcome was a reduction response rate of ≥50% with p < 0.005 with respect to headache characteristics. The secondary outcome was migraine disability assessment. We evaluated patients every four weeks for three months: T1: week 4, T2: week 8 and T3: week 12. The safety profile was also assessed. Thirty patients were randomly assigned to each group. However, 43 patients completed the trial. Headache frequency decreased in amitriptyline group more effectively in T1 (p = 0.004). Amitriptyline was more successful in reducing the headache duration in all three periods (p < 0.005). There was no significant difference in severity improvement and reducing disability score between the two groups (p > 0.005). No serious adverse events were observed. Both medications are effective in ameliorating migraine headaches and related disabilities. However, amitriptyline appears be a preferable option over cinnarizine, given its faster onset of action, efficacy in reducing headache duration and longer-lasting effects.Trial Registration: The study was registered with the Iranian Registry of Clinical Trials (IRCT) under the code IRCT-20191112045413N1.

The Application of Umbilical Cord Blood-derived Platelet Gel for Skin Ulcers Associated With Chronic Graft-Versus-Host Disease in Pediatrics: A Randomized Trial

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative strategy against a variety of malignant and nonmalignant disorders. However, acute and chronic graft-versus-host disease (aGVHD and cGVHD, respectively) commonly complicate this approach, culminating in substantial morbidities, and mortalities. The integumentary system is the preponderant organ involved in cGVHD, and its response to existing treatments, including well-versed immunosuppressants and novel targeted therapies, is not desirable. Despite the rarity, ulcers of sclerotic skin cGVHD are treatment-refractory and associated with significant morbidities and an exaggerated risk of infectious complications. Platelet-rich plasma (PRP) and its derivatives are endowed with growth factors and proangiogenic molecules and hold regenerative potential. To assess the safety and efficacy of the application of platelet gel-containing dressing for the management of ulcerative skin cGVHD in pediatric patients. This randomized trial is conducted at the hematopoietic stem cell transplantation unit of the Children's Medical Center Hospital in Tehran, Iran. Twenty-one pediatric patients (aged between 5 and 15 years) were initially enrolled, and 16 met the inclusion criteria. All cases (4 females) were recipients of allo-HSCT who had been complicated with symmetrically or near-symmetrically ulcerative sclerotic skin cGVHD. Fresh umbilical cord blood (UCB) was obtained from healthy donors and underwent centrifugation using a novel PRP preparation kit in a single-step process. Platelet gel was produced by adding thrombin to the isolated buffy coat layer. Two similar ulcers of each patient were randomized to receive either conventional dressing or platelet gels up to 6 times. At each time point evaluation, ulcer size and its relative reduction compared to the basal size were recorded. Included patients received a total of 80 platelet gel-containing dressings. While the mean sizes of randomized ulcers at the beginning of the study were similar, their differences became significant 15 days after the initiation of intervention (P = .019). In addition, the mean reduction in the ulcers’ surface area (in comparison to their baseline values) was significantly higher for the intervention arm at all evaluation points (P = .001 for day 5 and P < .001 for subsequent time points). At the end of the trial, the number of ulcers with a more than 50% reduction in size was 14 (87.5%) in the intervention arm (including 6 completely healed ulcers) versus 1 (6.25%, which was not completely healed) in the control arm (P < .001). None of the patients exhibited any localized or systemic treatment-related adverse events. In this study, using a relatively large number of cases, we showed that UCB-derived platelet gel is a safe, feasible, and effective curative approach for skin ulcers of sclerotic skin cGVHD in pediatric patients. Designing upcoming trials on the efficacy of this therapeutic approach for ocular, mucosal, and acute skin GVHD is prudent. Retrospectively registered at the Iranian Registry of Clinical Trials (registration number IRCT20190101042197N1) on August 24, 2020.

Evaluation of Three Methods for the Treatment of Dentin Hypersensitivity: A Randomised Clinical Trial

ObjectivesIn this study, we aimed to compare the effectiveness of Gluma and high-power 980-nm diode laser, alone or in combination, in the treatment of cervical dentin hypersensitivity. MethodsA total of 20 patients (5 men and 15 women), aged 25 to 60 years, who met the inclusion criteria, were enrolled in this study. A total of 60 teeth were randomly divided into 4 groups: G1, 980 nm diode laser (in 2 sessions within a 1-week interval); G2, Gluma (in 2 sessions within a 1-week interval); G3, 980 nm diode laser plus Gluma; and G4: control. Thermal (cold spray) and air blast (air syringe of dental unit) stimuli were used to evaluate cervical dentin hypersensitivity in the patients. Their pain response was assessed using a visual analogue scale (VAS) before treatment (baseline), in the first treatment session (15 minutes after treatment), in the second treatment session (after 1 week), and in 2-week, 1-month, and 3-month follow-up sessions. The obtained data were analysed using non-parametric tests, including Kruskal–Wallis test, Friedman test, Mann–Whitney test, and Wilcoxon test, in SPSS Version 22 at a significance level of P < .05. ResultsBased on the results, there was a significant difference in the average VAS scores for cold and air blast stimuli between the 4 groups 1 month after the intervention (P < .05). Meanwhile, the laser group had the lowest VAS score for cold and air stimuli. On the contrary, no significant difference was found between the 4 groups 3 months after the intervention (P ˃ .05). ConclusionThe present results showed that 980-nm diode laser alone was more effective than the other 2 intervention methods for 1 month. Trial registrationThe study was registered in the Iranian Registry of Clinical Trials (IRCT20120901010703N5).

Adopting strategies with menopausal experiences: A systematic review.

Menopause is one of the most significant stages in women's life. It is accompanied by many complications and a serious challenge. This study aimed to assess the menopause experiences of Iranian women and compatibility strategies. We searched PubMed, Web of Science (ISI), Scopus, Ovid, and the Iranian Clinical Trial Registry and Magiran, SID, from January 1990 to January 2021. Psychological effects, sexual disorders, physical problems, bone pain, insomnia, fatigue, and hot flashes are all menopause experiences. Cultural factors, lifestyle, social factors, education level, employment and economic status, marital status, and the number of pregnancies and births can influence this experience. It is important that menopausal women are aware how menopausal compatibility and prepare for this period. Many factors have affected menopausal adopting strategies. Negative emotions, negative attitudes, worry, and anxiety, and their psychological effects exacerbate the annoying experiences of menopause and decelerate menopausal adoption. Social support and educational intervention were the practical menopausal adopting strategies. It will guarantee the health of menopausal women in the last third of their lives.

Could tranexamic acid be a suitable alternative to cryotherapy for symptomatic cervical ectopy? Results from a randomized clinical trial.

Cervical ectropion occurs due to the eversion of the endocervix that exposes glandular cells to the vaginal milieu. The aim of the present study was to evaluate and compare the clinical efficacy of effervescent vaginal tablets of tranexamic acid and cryotherapy in women with symptomatic cervical ectopy. The current randomized clinical trial was conducted on 92 samples of women with cervical erosive ectropion from March 20, 2022 to August 27, 2022. Participants were divided into two groups; the intervention group (n = 46) was treated with a 400 mg effervescent vaginal tablet of tranexamic acid and the control group (n = 46) underwent cryotherapy. All the patients were requested to visit weekly in the first month and then monthly for the next 3 months, and the outcomes encompass improvement of symptoms (leukorrhea, dyspareunia, pelvic pain, post-coital bleeding, and suprapubic pain) and cervical erosive ectropion view were monitored based on repeated examinations. In this study, no statistically significant difference was observed in cure rate of symptoms between study groups (P value > 0.05). Women in both the tranexamic acid and cryotherapy groups reported significant improvements in dyspareunia (34 [75%] vs 31 [67%]), pelvic pain (34 [75%] vs 34 [74%]), post-coital bleeding (37 [81%] vs 31 [67%]), leukorrhea (36 [78%] vs 36 [78%]), suprapubic pain (32 [71%] vs 33 [73%]) disappearance of cervical ectropion tranexamic acid (40 [86%], vs 39 [84%]). Our findings highlighted the equal effect of tranexamic acid and cryotherapy for treating cervical ectropion. Due to the ease of use, availability, and fewer side effects of tranexamic acid, it can be a suitable alternative to cryotherapy. IRCT20220115053719N1. The name of the registry: Iranian Registry of Clinical Trials. URL of registration: https://en.irct.ir/trial/61483.