Iranian Registry Of Clinical Trials Research Articles

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.

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. This study aimed to assess the safety and efficacy of the application of platelet gel-containing dressing against 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.

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)

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).

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.

Comparison of intra-articular platelet-rich plasma injection versus placebo for clinical outcomes in patients with knee osteoarthritis; a double-blind, randomized trial

Introduction: Osteoarthritis (OA) is a progressively debilitating condition that leads to musculoskeletal pain, particularly in the knee joint. Most clinical guidelines recommend platelet-rich plasma (PRP) for knee OA. However, the use of PRP in knee OA is increasing. Objectives: This study aimed to investigate the effects of intra-articular administration of PRP on the symptoms, lower limb function, and daily living activities in patients with knee OA. Patients and Methods: A double-blind, randomized, controlled clinical trial was conducted and 34 patients with grade 2 or 3 knee OA were enrolled. The knees of each participant were randomly allocated to receive either 3cc PRP injection (PRP knees) or needling only (control knees). Patients were evaluated by a general practitioner before, three, and six months after the intervention using the EuroQol-visual analog scales (EQ-VAS), the International Knee Documentation Committee (IKDC), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the Tegner Activity Score (TAS). Results: The mean (±SD) age of patients with knee OA was 56.6 ± 10.2 years. Seventy-point-six percent of patients were female. 67.6% and 32.4% of patients were in stages 2 and 3 of the disease, respectively. IKDC, WOMAC, TAS, and EQ-VAS scores in knees under PRP injection and control of knees, three and six months after injection showed significant improvement. Three and six months after the intervention, IKDC, WOMAC, TAS, and EQ-VAS scores in the PRP and control knees were not significant (P &gt; 0.05). Inter-group comparison indicated that the IKDC score significantly increased six months in comparison to three months (P = 0.048) in PRP knees, but not significant in the control knees (P = 0.133). TAS score in PRP and control knees significantly increased six months compared to three months after injection. WOMAC and EQ-VAS score in PRP and control knees was not significant at six months in comparison to three months after the intervention. Conclusion: Our findings could suggest safety and feasibility data for the intra-articular administration of PRP in patients with knee OA that may help to appraise a larger clinical trial. Findings show that PRP injection improves IKDC, WOMAC, TAS, and EQ-VAS scores, however, there was no significant difference with needling only (control knees). Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trial (identifier: IRCT2015010112823N2; https://en.irct.ir/trial/12827, Ethics committee reference number: 93/551664) and Research Registry (Research Registry Unique Identifying Number: researchregistry9843).

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.

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.

The effect of selenium supplementation on oxidative stress, clinical symptoms and mental health status in patients with migraine: a study protocol for a double-blinded randomized clinical trial

BackgroundDespite a number of recommended strategies, effective treatment of migraine remains elusive. Given the role of oxidative stress in the pathogenesis of migraine, selenium, as an antioxidant nutrient, may have a beneficial effect on migraine outcomes. However, no study has explored the effects of selenium supplementation on migraine symptoms, oxidative stress biomarkers, and mental health. Therefore, this randomized, double-blinded, placebo-controlled clinical trial aims to examine the effects of selenium supplementation among migraine patients.MethodsSeventy-two migraine patients will receive either 200 µg/day selenium supplement (n = 36) or placebo (n = 36) for 12 weeks in a randomized, double-blinded, placebo-controlled study. The severity, frequency, and duration of headaches, mental health indices including depression, anxiety, and distress, and quality of life, as well as biomarkers of oxidative stress such as nitric oxide (NO), malondialdehyde (MDA), total antioxidant capacity (TAC), and total oxidant status (TOS), will be measured at the baseline and end of the study. The intention-to-treat (ITT) approach will be used to estimate missing values. One-way analysis of covariance (ANCOVA) will be performed to detect the effect of selenium supplementation on outcome variables.DiscussionOxidative stress is recognized as a key contributor to migraine pathogenesis. Selenium is an essential trace element with antioxidant properties, capable of crossing the blood–brain barrier (BBB), holding promise to alleviate the oxidative stress and neurotoxicity. Thus, selenium may beneficially affect clinical symptoms and oxidative stress as well as the quality of life in migraine patients.Trial registrationThis trial was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir/) on 27 May 2023 with the code number IRCT20121216011763N60.

Empagliflozin improves left ventricular ejection fraction and end systolic volume in patients with type 2 diabetes mellitus and coronary artery disease: a post-hoc analysis of EMPA-CARD trial.

Sodium glucose co-transporter2 (SGLT2) inhibitors have exhibited cardioprotective properties in diabetes patients. The aim of this study was to investigate the effect of Empagliflozin on changes in echocardiographic parameters. This was a post hoc analysis of the EMPA-CARD trial which was a multicenter, triple-blind randomized controlled trial. Type 2 diabetes mellitus patients with concomitant history of coronary artery disease were randomized on a 1:1 ratio into two groups receiving either 10mg/day Empagliflozin or placebo. Patients with a history of heart failure (NYHA class 3-4) and ejection fraction (EF) < 40% were excluded. Trans-thoracic echocardiography was performed at baseline and at 26 weeks of intervention. A total of 69 (Empagliflozin = 39 and placebo = 30) patients underwent echocardiography. Significant changes were observed for left ventricular ejection fraction [standard error (SE) = 0.76; beta (95% correlation interval (CrI)] = -5.558 (-7.25; -4.18) and left ventricular end-systolic volume (SE = 1.38; beta (95% CrI) = 3.915 (1.2; 0.66). Other echocardiographic parameters relating to right ventricular or atrial function did not change significantly. Empagliflozin can have cardioprotective benefits in subjects without HF. Further studies are required to determine the effect of Empagliflozin in non-HF patients. The original EMPA-CARD study has been registered in Iranian Registry of Clinical Trials. www.IRCT.ir, Identifier: IRCT20190412043247N2. Registration Date: 6/13/2020. Registration timing: prospective.

Effects of manual therapy in addition to stretching and strengthening exercises to improve scapular range of motion, functional capacity and pain in patients with shoulder impingement syndrome: a randomized controlled trial

BackgroundThe current study aimed to measure the effectiveness of manual therapy in addition to stretching and strengthening exercises in patients with shoulder impingement syndrome to improve functional capacity, pain, and scapular range of motion.MethodsThis is a single-blinded randomized controlled trial. Thirty-two participants with chronic shoulder impingement syndrome were randomly allocated into two groups. Both groups received stretching and strengthening exercises while the treatment group was given manual therapy additionally. Treatment was started after the patients signed an informed consent form. The data were collected from the University of Lahore Teaching Hospital between March 2022 and December 2022. The study aimed to measure pain using a numeric pain rating scale, functional capacity was assessed by the disability of the arm and shoulder, and goniometry was used for scapular ranges, i.e., scapular protraction and upward rotation. Each treatment session lasted 45 min for the treatment group and 30 min for the control group. The treatment comprised five days a week for four weeks, after which post-intervention measurements were taken.ResultsThirty-two participants were enrolled in the study, and 16 were divided into each group. The mean age of the participants in the treatment group was 38.19 ± 7.31 while the comparison group was 35.69 ± 7.98. An independent sample t-test was run on the data with a 95% confidence interval, statistically significant results were obtained, i.e., p-value < 0.05, post-intervention in the treatment group. Both groups have significantly improved functional capacity and scapular protraction (p < 0.005), however, pain and scapular upward rotation were not found statistically significant in the control group (p > 0.05).ConclusionThe addition of manual therapy along with exercise therapy showed clinical and statistical significant results for pain, functional capacity, and scapular range of motion. It demonstrated superior effects than exercise therapy alone for the chronic condition of SIS.Trial RegistrationThe trial was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir/) with the registration number: IRCT20230526058291N1, (Date: 12/08/2023).

An integrated theory based-educational intervention to change intention to have a child: study protocol of a cluster randomized controlled trial

BackgroundIn high- and low-income countries, declining birth rates have become a global concern. Couples do not have enough information about the complications of delaying and reducing childbearing and this leads them to make inappropriate decisions. Therefore, this study aims to evaluate whether an educational program based on integrating the Theory of Planned Behavior (TPB) and the Trans-Theoretical Model (TTM) affects child-free couples’ intention to have children and minimizes the consequences of this decline.MethodsThirty couples (intervention, n = 15; control, n = 15) will be enrolled in this cluster randomized controlled trial. After collecting baseline data and separating participants in the pre-contemplation and contemplation stages based on the TTM, the samples were randomly assigned to the intervention and control groups. The intervention group will receive 60-min training based on TPB components for 4 weeks. The first follow-up assessment was performed immediately after the intervention and the final assessment 6 months later. For all 3 time assessments, three questionnaires will be used: The knowledge questionnaire, the TTM, and the TPB questionnaire. The most important consequences are changes in knowledge, attitudes, subjective norms, perceived behavioral control, and stages of intentions to have children.DiscussionDecision-makers will use the results of this study as a basis to design appropriate, transparent, and useful policies and interventions to improve or stop the decline of the fertility rate at the national level. Also, this study will help young couples who wish to have a child in their lifetime by providing relevant information so that they do not miss this opportunity and face the consequences of delaying having a child.Trial registration This study was approved by the Iranian Registry of Clinical Trials (IRCT), Number: IRCT20220618055210N2, Date of registration: 2023-10-03

Therapeutic Effects of Intralesional Injection of Vitamin D3 in Treatment of Recalcitrant Warts: An Evaluator-Blinded Clinical Trial

Background: Viral warts are a prevalent infection that affects people all over the world. Unfortunately, there is no proven antiviral treatment for them. Recalcitrant warts are also difficult to resolve and deciding on a strategy for their treatment is challenging. Recently immunotherapy modalities have led to desired treatment outcomes in patients. This study investigated the efficacy of vitamin D injection (as an immunotherapeutic agent) in the treatment of recalcitrant warts. Methods: In this clinical trial study, 40 patients were divided into two groups: the first group (intervention group) received cryotherapy with an intralesional injection of vitamin D3 (0.1 cc of vitamin D3 (300000 IU/1mL) per lesion and a maximum of 0.5 cc per session), and the second group (control group) received just cryotherapy. In each treatment session, patients were evaluated for treatment responses and any side effects. Each patient received four treatment sessions at 2-week intervals. Results: After 4 treatment sessions, the rate of response in the intervention group and the group that received just cryotherapy was 95.33%±5.87 and 76.67%±25.14, respectively, and this difference was significant (P&lt;0.01). Furthermore, 57% (26 out of 45) of the lesions in the intervention group were completely resolved after 4 sessions, and the rest showed a moderate response to this treatment. Moreover, the minimum response rate was 80% in the intervention group and 30% in the control group. Conclusion: In recalcitrant skin warts, intralesional injection of vitamin D3 combined with cryotherapy significantly increased the treatment response and reduced the financial burden imposed on patients. The limitation of this trial was the small sample size of patients without a follow-up plan after completing the treatment sessions. Trial registration: The Iranian Registry of Clinical Trials registered this study (identifier: IRCT20200513047434N1).