Triple-blind Randomized Clinical Trial Research Articles

Efficacy of a standardised herbal formulation in Helicobacter pylori positive patients with gastritis or peptic ulcer: a triple-blind randomised clinical trial

IntroductionPistacia atlantica subsp. kurdica and Quercus brantii are traditionally used for various gastrointestinal disorders. This study aimed to evaluate the effects of herbal formulation from these two herbs on Helicobacter pylori infection, as well as undertake phytochemical analysis. MethodsA total of 78 H pylori-infected patients were enroled in this triple-blind randomised clinical trial and divided into two equal groups. The intervention and control groups received herbal formulation and placebo capsules once a day besides conventional therapy for 2 weeks, respectively. Patients were asked regarding their clinical symptoms at baseline, 2 weeks, and 3 months after the start of treatment. Also, the urea breath test was applied to assess the effects of herbal formulation 3 months after the start of treatment, which showed a significantly higher rate of H pylori eradication in the intervention group. ResultsWe found that the frequency of clinical symptoms was significantly lower in the intervention group 2 weeks after the start of the study. As well, the standardisation of the herbal formulation was performed according to volatile and nonvolatile compounds by GCMS/FID (gas chromatography mass spectrometry/flame ionization detector) and HPLC-PDA (high pressure liquid chromatography/photodiode array). ConclusionsGenerally, our results confirm the beneficial effects of herbal formulation on H pylori infection in line with its local application. Trial registrationIRCT20120215009014N233.

Effects of risperidone/paliperidone versus placebo on cognitive functioning over the first 6 months of treatment for psychotic disorder: secondary analysis of a triple-blind randomised clinical trial

The drivers of cognitive change following first-episode psychosis remain poorly understood. Evidence regarding the role of antipsychotic medication is primarily based on naturalistic studies or clinical trials without a placebo arm, making it difficult to disentangle illness from medication effects. A secondary analysis of a randomised, triple-blind, placebo-controlled trial, where antipsychotic-naive patients with first-episode psychotic disorder were allocated to receive risperidone/paliperidone or matched placebo plus intensive psychosocial therapy for 6 months was conducted. A healthy control group was also recruited. A cognitive battery was administered at baseline and 6 months. Intention-to-treat analysis involved 76 patients (antipsychotic medication group: 37; 18.6Mage [2.9] years; 21 women; placebo group: 39; 18.3Mage [2.7]; 22 women); and 42 healthy controls (19.2Mage [3.0] years; 28 women). Cognitive performance predominantly remained stable (working memory, verbal fluency) or improved (attention, processing speed, cognitive control), with no group-by-time interaction evident. However, a significant group-by-time interaction was observed for immediate recall (p = 0.023), verbal learning (p = 0.024) and delayed recall (p = 0.005). The medication group declined whereas the placebo group improved on each measure (immediate recall: p = 0.024; ηp2 = 0.062; verbal learning: p = 0.015; ηp2 = 0.072 both medium effects; delayed recall: p = 0.001; ηp2 = 0.123 large effect). The rate of change for the placebo and healthy control groups was similar. Per protocol analysis (placebo n = 16, medication n = 11) produced similar findings. Risperidone/paliperidone may worsen verbal learning and memory in the early months of psychosis treatment. Replication of this finding and examination of various antipsychotic agents are needed in confirmatory trials. Antipsychotic effects should be considered in longitudinal studies of cognition in psychosis.Trial registration: Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au/; ACTRN12607000608460).

The effects of Alpha-2a and Beta-1a Interferons on the Coronavirus disease 2019 prognosis.

The pandemic coronavirus disease 2019 (COVID-19) has been associated with substantial mortality worldwide. Efforts have continued to find an effective treatment for COVID-19. In vitro activity of interferon (IFN) subtypes has been shown against the SARS-CoV and MERS-CoV. Furthermore, the superiority of IFN-β over IFN-α2b and IFN-α2a has been demonstrated in MERS treatment. Early studies showed a low plasma level of IFNs in the peripheral blood or lungs of patients with severe COVID-19. This study assessed the effects of IFN-alpha-2a and -beta-1a on the prognosis of patients with covid-19 infection. We conducted a triple-blind randomized clinical trial on adult patients with moderate to severe COVID-19 from April 2021 to June 2021. The patients were diagnosed based on clinical and laboratory findings and randomly assigned into four groups (A, B, C, and D) using the envelope allocation method. Patients in group A received IFN β-1a; group B received IFN β-1a placebo; group C received IFN α-2a, and group D was treated with IFN α-2a placebo. All patients concomitantly received the national protocol medications as well. A total of 95 eligible patients were randomly assigned into groups. National Early Warning Score 2 (NEWS2) index showed significant differences between groups only on the first day of admission (p-value = 0.001). CT scan scores on the first and tenth days slightly improved, although they were not statistically significant. Duration of hospitalization and hospital discharge did not significantly differ among all treated groups (Table 1). Mortality rates showed no significant statistical difference between the groups. However, viral clearance significantly accelerated in the patients receiving IFN β-1a or IFN α-2a (p < 0.05). It seems that IFN α-2a and IFN β-1a are ineffective in treating COVID-19 patients. Further randomized clinical trials with large sample sizes are needed to estimate the effects of IFN α-2a or IFN β-1a on the outcomes of COVID-19 disease.

The effect of probiotic supplementation on episiotomy wound healing among primiparous women: a triple-blind randomized clinical trial

BackgroundProbiotics increase the defense power of immune system and accelerate the wound healing process by anti-inflammatory mechanisms at the wound site. The present study aimed at evaluating the effect of Lactobacillus casei oral supplementation on episiotomy wound healing among primiparous women.MethodsThis triple-blind randomized clinical trial was performed on 74 primiparous women delivered in Alzahra Hospital, Tabriz, Iran. Participants with mediolateral episiotomy (incision length equal to and less than 5 cm) were randomly assigned to the probiotic and placebo groups. The probiotic group received Lactobacillus casei 431 with 1.5 * 109 colony-forming unit /capsule once a day from the day after birth to 14 days. Wound healing as a primary outcome was measured by Redness, Edema, Ecchymosis, Discharge, Approximation and pain as a secondary outcome by the Visual Analogue Scale before discharge, 5 ± 1 and 15 ± 1 days after birth. The data were analyzed using independent t-test and repeated measures one way analysis of variance.ResultsThe mean (standard deviation: SD) score of wound healing in the probiotic group altered from 4.91(1.86) before discharge to 1.55 (0.99) during 5 ± 1 days after birth and reached to 0.95 (0.27) during 15 ± 1 days after birth. Further, the mean (SD) score of wound healing in the placebo group altered from 4.62 (1.99) before discharge to 2.80 (1.20) during 5 ± 1 days after birth and reached to 1.45(0.71) during 15 ± 1 days after birth (adjusted mean difference: -0.50, confidence interval 95%: -0.96 to -0.05, P = 0.03).ConclusionLactobacillus casei oral supplementation is effective in healing episiotomy wounds. It is suggested to evaluate the effect of topical use of Lactobacillus casei on episiotomy repair and pain in further studies.Trial registrationIranian Registry of Clinical Trials (IRCT): IRCT20170506033834N7. Date of registration: 11/08/2021.

The Effect of a Combined Topical Herbal Cream on the Incidence and Severity of Striae Gravidarum in Primiparous Women: A Randomized Clinical Trial

Background: Striae gravidarum, which occurs in most pregnancies, is unpleasant for women, and its treatment is costly. A preventive measure for this condition is applying herbal oils to maintain the skin's elasticity. The current study investigated the effect of a topical combined herbal cream on the occurrence and severity of striae gravidarum in primiparous women. Methods: In this triple-blind randomized clinical trial, 90 primiparous women in their first trimester of pregnancy, attending healthcare centres in Mashhad, Iran, were randomly allocated into two groups of herbal cream and placebo, from which 54 completed the study. The intervention group received 0.3 g of the cream, topically, composed of Calendula (Pot marigold), Anthemis nobilis (Chamomile), Pelargonium Graveolens (Rose Geranium), Theobroma oil (Cocoa Butter) and Soybean, twice a day for three days a week from 14-16 to 27-30 weeks of gestation and the placebo group received a moisturizing cream. At the gestational age of 38-40 weeks, the incidence and severity of striae on the abdominal skin were evaluated using the Atwal numerical scoring system and digital photography. Results: There was a significant difference between the prevalence of striae in the intervention and placebo group (43.3% vs 87.5%) (P&lt;0.0001). Also, a significant difference was seen between the two groups in terms of the severity of the striae (P &lt; 0.001). In the intervention group, the severity of striae in 86.7%, 13.3%, and 0% of the cases was mild, moderate, and severe, respectively, whereas, in the placebo group, it was occurred as mild, moderate, and severe in 37.5%, 58.3%, and 4.2% of the cases. Conclusion: Considering the effect of topically applied herbal cream, it is recommended that health care providers suggest pregnant women to use such herbal creams to avoid striae gravidarum development. Clinical Trial Registration Number: IRCT20190305042927

Assessing the effect of Alpinia galanga extract on the treatment of SSRI-induced erectile dysfunction: A randomized triple-blind clinical trial.

SSRIs are considered the first line in the medical treatment of depression and anxiety disorders. One of their most common side effects, sexual dysfunction, has led many patients to discontinuing their medication and treatment course. Alpinia galanga, a plant from the ginger family, has been shown to enhance androgenic activity and sexual function. This study aimed to assess whether the addition of Alpinia galanga extract to the treatment regimen of adult males consuming SSRIs can improve SSRI-induced erectile dysfunction. This triple-blind randomized clinical trial was conducted on 60 adult males who were being treated with SSRIs at the time of the study. The participants were divided into two groups, a group of 30 people receiving 500 mg of Alpinia galanga extract and a group of 30 subjects receiving placebo. The population were re-assessed on week 2 and week 4 of the study using the international index of erectile function (IIEF), the Beck Depression Inventory, and the Beck Anxiety Inventory. In all the tests, a p-value of 0.05 was considered as the cut-off for significance. At the beginning of the study, the IIEF scores of the placebo group and the intervention group were 10.6 ± 3.8 and 11.2 ± 4.8, respectively, which were not significantly different (p-value = 0.577). By week 4 of the study, the IIEF scores of the control group and the Alpinia galanga group had increased to 13.7 ± 4.3 and 17.4 ± 3.7 respectively, which demonstrates a remarkably larger increase in the group receiving Alpinia galanga extract in comparison to the placebo group (p-value < 0.001). In this study, the effect of the addition of Alpinia galanga extract to the treatment regimen of male patients using SSRIs on the sexual dysfunction experienced by this group has been promising. Similar results, if proven, can aid both patients and clinicians in making and following better treatment plans with more pleasant outcomes. [https://clinicaltrials.gov/], identifier [IRCT20101130005280N41].

The effect of nettle vaginal cream on subjective symptoms of vaginal atrophy in postmenopausal women

Background and objectiveVaginal atrophy is a condition where the vaginal epithelium gets thinner and includes symptoms, such as vaginal dryness, abnormal vaginal discharge, vaginal bleeding, dyspareunia, and sexual problems. Hormone therapy is associated with some problems and some women prefer herbal medicine to reduce vaginal atrophy. Considering the phytoestrogenic compounds present in the nettle, this study aimed to investigate the effect of the nettle vaginal cream on subjective symptoms of vaginal atrophy in postmenopausal women. Materials and methodsThis triple-blind randomized placebo-controlled clinical trial study was conducted on 84 eligible postmenopausal women aged 45–60 years, who referred to comprehensive health service centers in Aliabad Katul in 2021–2022. Women eligible for the study received 5% nettle vaginal cream and placebo for 8 weeks. Subjective symptoms of vaginal atrophy were assessed before, four and eight weeks after the intervention. Data collection tools included a checklist for research unit selection, individual and midwifery characteristics questionnaire, vaginal assessment scale (VAS), vaginal pH, laboratory results of the vaginal maturation value (VMV). Data analysis was performed using SPSS software (version 21) and independent t-test, Mann-Whitney, chi-square, Two-way analysis of variance and analysis of covariance. P value less than 0.05 was considered significant. ResultsSubjective symptoms of vaginal atrophy decreased significantly after the intervention compared to before the intervention in both the nettle and placebo groups (p < 0.001), but in the comparison between groups four weeks and eight weeks after the intervention, the subjective symptoms of vaginal atrophy in nettle group decreased significantly (p < 0.001). In the nettle group, the scores of vaginal burning, vaginal dryness, vaginal itching and dyspareunia significantly improved after the intervention compared to before the intervention (p < 0.001). Also, in the nettle group compared to the placebo group, after the intervention, vaginal burning and vaginal dryness score (p < 0.001) and vaginal itching score (0.004) improved significantly. ConclusionBased on the results of the present study, Nettle vaginal cream reduced subjective symptoms of vaginal atrophy, including vaginal burning, vaginal dryness, vaginal itching, and dyspareunia in postmenopausal women, so it is a cost-effective, available and do not have the side effects product that can be useful for menopausal women.

The effect of chamomile on nausea and vomiting after laparoscopic cholecystectomy: A triple-blind randomized clinical trial

The present study aimed to evaluate the effect of Chamomilla Recutita on nausea and vomiting after laparoscopic cholecystectomy. Chamomilla Recutita (L.) fell into either chamomile or placebo groups randomly. The intervention was performed one hour before the operation. The severity of nausea and the frequency of vomiting was measured using a visual analog scale. Both groups were studied in three stages before the operation, after the operation in recovery, and 2 hours after the operation. Data were analyzed using descriptive and analytical statistics (SPSS). The mean severity of nausea increased significantly over time in both groups; however, this increase was significantly slighter in the chamomile group than that in the placebo group. The frequency of preoperative nausea in the chamomile and placebo groups was 6.2% and 25%, respectively, before being discharged from the recovery. Two hours later, in the surgical ward, this frequency was estimated to be 31.2% in the chamomile group and 75% in the placebo group (P &lt;0.05). The frequency of vomiting in the surgical ward was 15.6% and 56.2% in the chamomile and placebo groups, respectively. Thus, this frequency in the chamomile group was significantly lower than in the placebo group (P&lt;0.001). It seems that in laparoscopic surgeries, the use of chamomile drops as a preventive drug reduces postoperative nausea and vomiting.

Nd:Yag laser combined with injection sclerotherapy in the treatment of reticular veins and telangiectasias (CLaCS method): A triple-blind randomized clinical trial comparing two sclerosing agents associated with same laser patterns.

Cryo-Laser & Cryo-Sclerotherapy (CLaCS) is a technique which combines thermal sclerotherapy and injection sclerotherapy. Telangiectasias and small varicosities are targeted by a transdermal laser and right after receive injection sclerotherapy. A cooling device blows -20°C air onto the skin and needle in a pre-, parallel-, and post-fashion. Our objective was to establish if there is a difference in result and complications by varying the sclerosing agent but keeping the same ND:Yag long pulse laser parameters in the treatment of small varicosities. Fifty five patients were enrolled prospectively and randomized to two groups; in the group 1 dextrose 75% was the sclerosing agent used in combination with the ND:Yag long pulse laser and, in the group 2, the same laser technique was used but the sclerosing agent was polidocanol 0.3% and dextrose 67%. The results were evaluated 30days after the treatment by the patients and for blinded evaluators using before and after standardized photos with and without augmented reality. In the patient's perspective and in the blinded evaluation of the regular photos, no differences between the groups were found. Both groups had low rates of hyperpigmentation and bruising with no statistical difference. Patients treated with polidocanol had less pain after the treatment and a better clearance rate in the photos with augmented reality. No major complications were found. The treatment of small varicosities with CLaCS using Dextrose 75% or polidocanol 0.3% and Dextrose 67.5% is a safe and effective procedure and both sclerosing agents can be used with similar results. Possibly, in the polidocanol group more nonvisible reticular veins were cleared, but the implication of this find is not clear.

Effects of oral Shilajit tablets on sexual function and sexual quality of life among reproductive-aged women: a triple-blind randomized clinical trial

Effects of oral Shilajit tablets on sexual function and sexual quality of life among reproductive-aged women: a triple-blind randomized clinical trial

Evaluation the effects of red yeast rice in combination with statin on lipid profile and inflammatory indices; a randomized clinical trial

BackgroundDyslipidemia is a prominent cause of cardiovascular disease as it leads to inflammation and plaque deposition within arteries. Treatment includes lifestyle modifications and lipid-lowering medications. We aimed to assess the therapeutic effects of red yeast rice (RYR) alongside statin therapy.MethodsThis triple-blind randomized clinical trial involved 92 dyslipidemia patients and was performed in 2019. Standard laboratory tests were used to assess the serum LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), total cholesterol, triglyceride (TG), and high sensitivity C-reactive protein (hs-CRP) levels. Subsequently, patients randomly received one daily RYR or placebo tablet for 1 month beside routine single statin therapy. Subsequently, blood tests were repeated and compared against the baseline. Liver function tests were also requested.ResultsTotal cholesterol significantly (P = 0.019) decreased in the treatment group (− 10.2 mg/dL) compared with the placebo group (− 1.3 mg/dL). HDL cholesterol decreased by 2.19 mg/dL in the treatment group but increased by 0.53 mg/dL in the treatment group (P = 0.083). LDL cholesterol declined in both placebo (− 5.09) and treatment (− 0.73) groups (P = 0.187). TG increased by about 7 mg/dL in the treatment group but fell by roughly 1 mg/dL in the placebo group (P = 0.386). Hs-CRP increased by 0.28 mg/dL in the treatment group but decreased by 0.09 mg/dL in the placebo group (P = 0.336).ConclusionsWe found that adding RYR (Lesstat®) to statin medications significantly decreases total cholesterol. However, no significant effect was seen on other lipid profile components or Hs-CRP. Finally, we showed that RYR is safe to add to statins considering liver function (clinicaltrials.gov: NCT05095480).

The Effect of Sumac Fruit on Serum Lipids and Body Mass Index in Hemodialysis Patients.

Sumac fruit is an antioxidant and reduces serum triglyceride (TG) and cholesterol (CHOL) levels. Therefore, this study aimed to investigate the effect of sumac fruit on serum lipids and body mass index (BMI) of hemodialysis (HD) patients. This triple-blind randomized clinical trial study was conducted for 12 weeks on HD patients. Participants were randomly divided into three groups of 2-gram sumac (N = 40), 3-gram sumac (N = 40), and placebo (N = 40) by nonprobability consecutive sampling and stratified block randomization method based on inclusion criteria. Serum lipids and BMI were measured at the beginning of the study and also at the end of the sixth and the twelfth weeks. The physical activity and 24-hour dietary recall questionnaires were used to collect data. No significant difference was found between the level of nutrient and micronutrient intake (P > 0.05), physical activity (P=0.159), and BMI (P=0.718) of patients in the three groups before and after the intervention. However, the difference in serum low-density lipoprotein (LDL) levels in each studied group was significant over time (P < 0.001). The difference was not statistically significant between the groups before the intervention, 6 and 12 weeks after the intervention (group effect), and between the study groups over time (time-group interaction). No statistically significant difference was observed between the mean levels of TG (P=0.875), CHOL level (P=0.969), LDL level (P=0.998), high-density lipoprotein (HDL) level (P=0.136), and BMI (P=0.608) in the groups over time. Consumption of sumac fruit significantly changed the LDL level over time. Although BMI and serum lipids changed in HD patients, these changes were not significant. Future studies are needed to determine the effective dose of sumac and any dose increase should take toxicity into account and consider a larger sample size and longer intervention and follow-up times.

The effect of a 10-week aerobic exercise on cardiac function among overweight female breast cancer survivors; a randomized clinical trial

Introduction: Breast cancer is the most common and deadliest cancer among women. Objectives: The aim of this study was to evaluate the effect of 10-week aerobic exercise on cardiac function among overweight female breast cancer survivors. Patients and Methods: This triple-blinded randomized clinical trial was carried out among 25 overweight female breast cancer survivors (age range; 30-55 years). The aerobic exercise training protocol was performed for 10 weeks with an intensity of 40 to 75% of maximal heart rate. Anthropometric parameters and body composition of patients were measured (pre-test/post-test design). Echocardiography was used to determine the ejection fraction and pulmonary artery pressure of the patients too. Results: There was no significant difference between anthropometric parameters and body composition of patients in the control and exercise groups. Additionally, there was a significant difference in the ejection fraction (P=0.001), PAP (P = 0.025) and VO2max between patients of control and exercise groups (P=0.001). Conclusion: A 10-week aerobic exercise leads to an increase in the levels of VO2max, ejection fraction and pulmonary arterial pressure. Trial Registration: Registration of trial protocol has been approved by Iranian Registry of Clinical Trials (identifier: IRCT20190218042745N1, https://www.irct.ir/trial/37684, ethical code; IR.MUI.REC.1396.2.082).

Effect of Rosemary Cream on Episiotomy Wound Healing in Primiparous Women: A Randomized Clinical Trial

BackgroundDelay in episiotomy wound healing can lead to infection. The application of natural antimicrobial agents isolated from herbal essences can be a good strategy to prevent the growth of bacteria and promote the wound healing process. Therefore, this study aimed to determine the effect of rosemary cream on episiotomy wound healing in primiparous women.MethodsThis triple-blind randomized clinical trial was conducted on 80 primiparous pregnant women who were referred to the maternity ward of Shahid Motahari Hospital in Marvdasht, Iran, from September 2019 to March 2020. These women were randomly assigned into two groups of intervention (rosemary cream) and control (placebo), using variable quadruple blocks. Both groups applied the prescribed cream (in a dose of 2 cm) uniformly on the sutured area to cover it with the cream. The cream was applied twice a day for 10 consecutive days postpartum, and the rate of wound healing was evaluated by the researcher in the first 12 h and at days 4 and 10 postpartum using the REEDA scale. The data were analyzed using SPSS software (Version 19) through the Chi-square test, Mann-Whitney U test, student’s t-test, and Fisher’s test. A p-value less than 0.05 (P < 0.05) was considered statistically significant.ResultsThe mean ± SD REEDA score on the fourth day postpartum was obtained at 3.82 ± 0.93 and 4.25 ± 1.29 in the groups of rosemary cream and placebo, respectively (P = 0.17). However, the mean ± SD REEDA scores on the 10th day postpartum were determined at 0.75 ± 0.74 and 3.32 ± 2.54 in the rosemary cream and placebo groups, respectively, indicating a higher rate of episiotomy wound healing in the group of rosemary cream compared to placebo (P < 0.001).ConclusionBased on the obtained results, it seems that rosemary cream can be effective in healing episiotomy wounds in primiparous women. However, further studies are suggested to confirm the findings of this study.Trial registrationThis trial was registered in the Iranian Registry of Clinical Trials in 24/08/2019 with the IRCT ID: IRCT20190308042971N1. The first participant enrolled in this trial in September 2019. URL of registry: https://en.irct.ir/trial/40092.

A randomized triple-blind controlled clinical trial evaluation of sitagliptin in the treatment of patients with non-alcoholic fatty liver diseases without diabetes.

The current study aimed to evaluate the efficacy of sitagliptin vs. placebo in treating non-alcoholic fatty liver disease (NAFLD). In a triple-blind randomized clinical trial, we assigned 120 eligible subjects with NAFLD to receive daily dosing of 50 mg sitagliptin (n = 60) or the placebo (n = 60) for 56 weeks and lifestyle modification in both groups. Laboratory and anthropometric outcomes were measured, and liver stiffness was assessed using a fibroscan. The primary outcome measures were changes from baseline in fibrosis scores and liver transferases. Out of 120 patients randomized into sitagliptin and placebo groups, 76 patients completed the trial, of whom 44 were in the sitagliptin and 32 in the placebo groups. Patients receiving sitagliptin showed a significant decrease in the fibrosis scores (P = 0.001). The reductions in the alanine aminotransferase (AST) (P = 0.036) and aspartate AST (P < 0.001) levels were also statistically significant. The effect of sitagliptin in reducing fibrosis scores was significantly greater in normal-weight and overweight individuals than in obese individuals (p = 0.036, and p = 0.018, respectively), whereas the effects of sitagliptin on AST levels were greater among overweight/obese patients (p = 0.028, and p = 0.016, respectively). Sitagliptin reduced fibrosis scores and liver enzymes in NAFLD patients after 56 weeks of therapy. The changes in fibrosis scores were more prominent in patients with normal weight and overweight than obese patients, whereas the effects on AST levels were greater among overweight/obese patients. Other randomized trials with larger sample sizes and longer treatment durations may be required before precise results can be reached.Clinical Trial Registration[https://www.irct.ir/trial/46140], identifier [IRCT20140430017505N2].

Is Preemptive Oral Tizanidine Effective on Postoperative Pain Intensity after Bimaxillary Orthognathic Surgery? A Triple-Blind Randomized Clinical Trial.

Background:We aimed to investigate the effect of preoperative administration of oral tizanidine on postoperative pain intensity after bimaxillary orthognathic surgery.Methods:All healthy skeletal class III patients who were candidates for bimaxillary orthognathic surgery were enrolled in this triple-blind randomized clinical trial. The study was carried out in the Maxillofacial Surgery Department of Qaem Hospital, Mashhad, Iran; from January 2021 to November 2021. The consecutive patients were randomly divided into tizanidine and placebo groups. One hour prior to anesthesia induction, the tizanidine group received 4 mg Tizanidine dissolved in 10 ml apple juice, whereas the placebo group received an identical glass of plain apple juice. All operations were performed by the same surgical team, under the same general anesthesia protocol. Postoperative pain was measured using the Visual Analogue Scale (VAS) at 3, 6, 12, 18, and 24 hours. For statistical analysis; the significance level was set at 0.05 using SPSS 23.Results:A total of 60 consecutive patients, consisting of 36 females (60%) and 24 males (40%) with an average age of 25.4 ± 6.0 were recruited. An increasing trend was noticed in the amount of perceived postoperative pain from the 3rd till 12th hour, and then decreased afterward. Nevertheless, the average amount of pain was significantly lower in the tizanidine compared to the placebo group, in all the evaluated time intervals (P<0.001). Moreover, there was a significantly higher requirement for postoperative opioid analgesics in the placebo compared to the tizanidine group (P=0.011). Conclusion:The addition of oral tizanidine was effective in reducing postoperative pain following bimaxillary orthognathic surgery. Further studies are necessary for more relevancy.

A Comparative Study on the Effects of "Honey and Fenugreek" with "Fenugreek" on the Breastfeeding Success: A Randomized Trial.

Objective Herbal galactagogues are usually recommended to be sweetened with honey. Despite the high nutritious value of honey for lactating women and extensive studies on the effects of herbal galactagogues, no investigation was made to compare galactagogue effects of using herbal galactagogues with and without honey so far. The present study aimed to compare the effect of a combination of “honey and fenugreek” with “fenugreek” on breastfeeding success (BFS). Methods This study is a triple-blind randomized clinical trial on 75 breastfeeding mothers referred to a Tehran-Iran health center. The participants were randomly divided into two intervention (fenugreek and honey users) and control (fenugreek users) groups. These women had infants of 1–5 months and had exclusive breastfeeding practice. Tools for data collection were (1) the personal and maternal-infant information, (2) the breastfeeding success, and (3) the complications questionnaires. Participants received 30 liquid drops, three times daily for four weeks. The BFS questionnaire was completed twice, before and 4 weeks after the intervention. The CONSORT checklist was followed. Results Before and after comparison showed no significant difference in the BFS score in the “fenugreek” group, while there was a significant increase in the BFS score in the “honey and fenugreek” group (P=0.035). Between groups, comparison demonstrated a significantly higher score of BFS in the intervention group than in the control group (P=0.023). There were no significant differences between the two groups regarding the possible complications. Conclusion The combination of honey with fenugreek showed a significant effect on BFS, while there was no improvement in BFS after fenugreek only uses. Trial registration: the study was approved in the Iranian registry of clinical trials with IRCT ID: IRCT20120122008801N23 on 2019-12-30 (https://www.irct.ir/).

Efficacy of a standardized herbal product from Pistacia atlantica subsp. Kurdica in type 2 diabetic patients with hyperlipidemia: A triple-blind randomized clinical trial

BackgroundHyperlipidemia is one of the consequences of type 2 diabetes mellitus (T2DM) that puts the patients at the risk of getting cardiovascular disease. Pistacia atlantica subsp. Kurdica is used by local people for the improvement of lipid and glucose indices. This study was carried out to evaluate clinical effects of P. atlantica subsp. Kurdica on hyperlipidemia related to T2DM patients. Materials and methodsIn this randomized, triple-blind, and placebo-controlled study, type 2 diabetes patients with hyperlipidemia were randomly allocated to receive either P. atlantica kurdica or placebo capsule for 2 months. 58 Patients were followed up at the beginning and after the end of each month for assessment of lipid profiles, glucose indices, and liver and renal function tests. The herbal capsule was standardized according to volatile and nonvolatile compounds by GC-MS/FID and RP-HPLC-PDA, respectively. The total phenolic and flavonoid contents were also determined with a spectrophotometer. ResultsAfter 1 and 2 months of the intervention period, mean differences of 2HPP, total cholesterol, and LDL-c have been reduced significantly (P < 0.05) between the two groups, but there were not reported any significant statistical changes in FBS, HbA1c, TG, HDL-c, ALT, AST, and Cr. The herbal capsule was standardized according to benzoic acid, ballic acid, rutin, and quercetin standard (6.5, 2.1, 1.4, 0.7 mg, respectively), and also α-pinene as major volatile constituent 28.51%. ConclusionAccording to results the P. atlantica kurdica is effective in the improvement of lipid profile and glucose indices in line with its local application. Clinical trial id(IRCT201708109014N178).

The effects of licorice mucoadhesive patches (Aftogel®) on the results of nasopharyngeal swab real-time PCR test of SARS-CoV-2: a randomized triple-blind placebo-controlled clinical trial

Background and objectives: Up to present no efficacious antiviral medications have been discovered in order to eradicate SARS-CoV-2 in nasopharyngeal tract. In this article, the aim is to evaluate the effectiveness of a new herbal drug product called Aftogel patch, which contains licorice extract, in the eradication of this novel coronavirus in the nasopharyngeal secretions of the patients. Methods: In this triple-blind randomized clinical trial, 125 patients with positive real-time PCR for SARS-CoV-2 and in stage 0 and/or 1 of COVID-19 were studied in two separate groups, namely interventional and placebo, in which they used Aftogel and placebo patches, respectively. At the end of the study, the results of PCR test in aforementioned groups were assessed and compared. Results: Following the application of Aftogel, Real-time PCR was converted to negative in 53.97% of patients which was significantly higher than that of the placebo groups. (27.40%, P= 0.003). Conclusion: It seems that Aftogel mucoadhesive patch (Licorice extract) is effective in the eradication of SARS-CoV-2 which has colonized the nasopharyngeal area. Hence, this drug product has the potential for evaluation as a prophylactic agent against COVID-19.

The effect of calcium and vitamin D supplements on blood pressure in postmenopausal women: myth or reality?

Hypertension is a highly prevalent disease with serious cardiovascular and renal complications. Many studies have demonstrated a weak correlation between the consumption of calcium (or calcium plus vitamin D) and blood pressure, suggesting that calcium supplements might reduce blood pressure. However, the results to date remain controversial. In this study, we assessed the effect of calcium and vitamin D supplementation on the blood pressure of postmenopausal women with hypertension as a population group in which the use of calcium supplements is prevalent. This triple-blind randomized clinical trial enrolled 98 women of postmenopausal age with hypertension in 2019. The study period was 8 weeks with close follow-up. We used 24-h ambulatory blood pressure monitoring to record the initial and final blood pressure in all participants. The changes in both the mean systolic (p = 0.047) and diastolic blood pressure (p = 0.015) were suggestive of an increase in blood pressure after consuming calcium and vitamin D supplements. Among patients who had been using calcium channel blockers, calcium and vitamin D supplementation caused a notable increase compared to baseline systolic (p = 0.019) and diastolic blood pressures (p = 0.001). The present results differ from those of previous studies. This suggests that calcium supplementation for postmenopausal women with hypertension requires the close observation of blood pressure to prevent any further increase, especially in women who are being treated with calcium channel blockers (clinicaltrial.gov registration: NCT04618952).