Triple-blind Randomized Clinical Trial Research Articles

Chronic fatigue syndrome post-COVID-19: triple-blind randomised clinical trial of Astragalus root extract

ObjectiveThis study aimed to evaluate the effect of Astragalus root extract on nurses suffering from post-COVID-19 chronic fatigue syndrome.Materials and methodsThe study was designed as a triple-blind, randomised, controlled trial...

Evaluation of the effects of pregabalin and dexamethasone coadministration on preemptive multimodal analgesia and anxiety in third molar surgeries: a triple-blind randomized clinical trial.

To evaluate the efficacy of pregabalin and dexamethasone coadministration in preemptive analgesia and anxiety control in lower third molar surgery. A triple-blind, split-mouth clinical trial conducted with patients divided into two groups: control group, receiving placebo and dexamethasone, and test group, receiving pregabalin and dexamethasone preoperatively. The evaluated variables were pain, measured by the Visual Analog Scale (VAS), anxiety assessed through the State-Trait Anxiety Inventory (STAI) questionnaires, hemodynamic parameters [Blood Pressure (BP), Heart Rate (HR), Oxygen Saturation (SpO2)], and sedation assessed by the Ramsay scale. A total of 31 patients were included. The test group exhibited a significant reduction in pain at 2,4,6,8,12,16,24, and 48h after surgery and in the consumption of rescue analgesics. Anxiety, evaluated by STAI and VAS, showed a significant decrease in the test group (p < 0.001). Additionally, there was a significant decrease in BP at most of the assessed time points (p < 0.05) and a significant reduction in HR at two different time intervals (p = 0.003 and p = 0.009), indicating a positive effect in the test group. There was no significant difference in SpO2 between the groups. Sedation assessment revealed a significant difference at all time points favoring the test group (p < 0.05). There were no significant postoperative adverse effects. Pregabalin coadministered with dexamethasone demonstrated significant efficacy in controlling postoperative pain and anxiety, as well as a sedative effect. The coadministration of pregabalin with dexamethasone may presents potential advantages in both pain modulation and psychological well-being of individuals undergoing third molar surgeries. Brazilian Clinical Trials Registry (REBEC), No. RBR-378h6t6.

Comparing the efficacy of fluconazole and cryotherapy Versus cryotherapy alone on treating cutaneous leishmaniasis: a triple-blind randomized clinical trial

ObjectiveCutaneous Leishmaniasis (CL) is one of the highly prevalent endemic diseases in the Middle East. The disease is a complex skin infection imposing a heavy burden on many developing countries. This study aimed to evaluate the impact of adding oral fluconazole to topical cryotherapy on the treatment efficacy and time to achieve complete recovery of CL lesions.MethodThis triple-blind randomized clinical trial included 52 participants with CL. Participants were allocated to receive either weekly cryotherapy with liquid nitrogen and oral fluconazole at a dose of 6 mg/kg daily at a maximum of 400 mg for 6 weeks as the interventional arm or weekly cryotherapy with liquid nitrogen plus the placebo for the same period of 6 weeks as the control arm.ResultsFifty-two eligible participants enrolled the study, with a CL lesion count of 1 to 8 (mean 1.96), and served as the interventional (n = 28) and control (n = 24) arms. The trend of the mean surface area of the lesions was significantly decreasing in both arms (P < 0.001), with no statistically significant difference between arms (P = 0.133) or all assessed time point pairwise comparisons (P > 0.05). There was no significant difference between the treatment arms in terms of the end-point recovery status (P = 0.491) or the frequency of post-treatment secretion (P = 0.437). No adverse effect was observed.ConclusionDespite a slightly higher reduction in the lesion surface in the cryotherapy and fluconazole treatment arm, the addition of fluconazole did not provide statistically significant therapeutic value to cryotherapy in the treatment of CL. However, with adjustment for the initial lesion size, the efficacy of the regimen in the interventional arm was more pronounced, though it was still insignificant.

Bleeding Reduction by Acupuncture in Rhinoplasty: A Triple-Blind Randomized Clinical Trial

Background: Bloodless surgical field obtained by controlled hypotension reduces the bleeding, the surgical time and improves outcome of rhinoplasty and other facial plastic surgeries.&#x0D; Since acupuncture is used for epistaxis, this study was designed to investigate its effectiveness in reducing the bleeding in open rhinoplasty.&#x0D; Methods: In a triple-blinded randomized clinical trial, 88 patients with ASA I and II physical status, aged between 20 – 48 years, who were candidates of open rhinoplasty were enrolled in the study.&#x0D; After randomization, 44 patients were assigned to each group of acupuncture or control. They were given identical anesthesia. In addition to the hemodynamic monitoring, blood loss was assessed in all patients and compared between the two groups.&#x0D; Results: There were statistically significant differences between two groups in terms of the amount of bleeding (P = 0.001) and surgeon satisfaction (P = 0.010). Coagulation indicators were similar in both groups (All P &gt; 0.05). Mean SBP and DBP, average HR and average MAP in both acupuncture and control groups did not show significant differences (All P &gt; 0.05). Adverse events such as bradycardia or hypotension requiring treatment were not seen.&#x0D; Conclusion: Our findings demonstrated that acupuncture could reduce bleeding during rhinoplasty without side effects.&#x0D;

Effect of Viola odorata vaginal suppository on menopausal vaginal atrophy: a triple-blind randomised clinical trial

IntroductionVaginal atrophy is an often neglected symptom of menopause, which affected about 90% of women. Women tend to use alternative medicine such as herbs rather than estrogen replacement therapy to alleviate it. Viola odorata contains flavonoids in the form of phytoestrogens and probably can be effective in treatment of vaginal atrophy. This study was conducted to investigate the effect of V. odorata vaginal suppository on menopausal vaginal atrophy. MethodsThis approved triple-blind randomised clinical trial, 8 weeks, study was conducted on 60 postmenopausal women from September 2022 until January 2023. Eligible participants were divided randomly into two groups of treatment (V. odorata suppository) and placebo (glycerine suppository) after obtaining informed consent. Data of the socio-demographic questionnaire, vaginal pH, and vaginal maturation index (VMI) were collected before and at the end of the study. Subjective symptoms of vaginal atrophy (dryness, irritation, itching, and dyspareunia) were assessed before, 4th, and 8th weeks of intervention period by self-assessments. Data were analysed using Independent t-test, Chi-square, Mann Whitney U, and Wilcoxon test by SPSS ver 23. ResultsThere were no significant differences between the two groups at the beginning of the study in vaginal atrophy symptoms, vaginal pH, and VMI. Subjective symptoms of vaginal atrophy (P < 0.001), vaginal pH (P < 0.001), and VMI (P < 0.001) were improved in the V. odorata group 8 weeks of treatment. ConclusionV. odorata vaginal suppository reduced the menopausal vaginal atrophy symptoms. Considering V. odorata is a natural product with low cost, it can use in menopausal vaginal atrophy treatment.

Efficacy of topical gabapentin in women with primary macular amyloidosis: A side-by-side triple-blinded randomized clinical trial.

Primary cutaneous macular amyloidosis (PCMA) is a chronic pruritic cutaneous disease characterized by heterogeneous extracellular deposition of amyloid protein in the skin. This study aimed to evaluate the efficacy of topical 6% gabapentin cream for the treatment of patients with PCMA. In this triple-blind clinical trial, a total of 34 patients, who were diagnosed with PCMA, treated using two different strategies of topical gabapentin as the active group and vehicle cream as the control group. Pruritus score reduction in both groups was statistically significant compared with the baseline value (p < 0.001). There was a significant pigmentation score reduction in intervention group compared with control group after 1 month of the study (p < 0.001). The differences of pigmentation score changes between the groups were not significant at month 2 (p = 0.52) and month 3 (p = 0.22). The results of this study suggest that topical gabapentin cream may be effective as a topical agent in the treatment of pruritus associated with PCMA without any significant adverse effects. It is recommended to perform similar studies with a larger sample size and longer duration in both sexes.

Comparison of the Effect of Two Drug Combinations: Ketamine-Midazolam -Sufentanil with Etomidate-Sufentanil on Changes in Heart Rate and Blood Pressure After Laryngoscopy and Endotracheal Intubation

Background: Due to the high prevalence of complications during and after laryngoscopy, especially hemodynamic disturbances, and the absence of a suitable solution for preventing these complications, this study was conducted to compare the effect of “Ketamine-Midazolam-Sufentanil” with “Etomidate-Sufentanil” combinations on changes in heart rate and blood pressure after laryngoscopy and endotracheal intubation.&#x0D; Methods: In this controlled, triple-blind randomized clinical trial, 96 laryngoscopy candidate patients were divided into three groups of 32 members and were given “Ketamine-Midazolam-Sufentanil” (KMS), “Etomidate-Sufentanil” (ES) and” Etomidate- Normal Saline” (NS) respectively before laryngoscopy. Hemodynamic parameter changes at baseline and 1,3,5 and 10 minutes after laryngoscopy, were measured and compared between the 3 groups.&#x0D; Results: During the study, the 3 groups KMS, ES, and NS had 0%, 15.6% and, 3.1% bradycardia respectively (p value = 0.024). Changes in systolic blood pressure were significantly different in the 3 groups (p value = 0.043). However, the incidence of tachycardia, hypertension, and hypotension were not significantly different among the 3 groups.&#x0D; Conclusion: Results of this study showed that using the “Ketamine-Midazolam-Sufentanil” combination before laryngoscopy can reduce hemodynamic disturbances during and after laryngoscopy. Patients who receive this drug combination seem to have more desirable hemodynamic stability during and after laryngoscopy.

Comparing the efficacy of intravenous morphine versus ibuprofen or the combination of ibuprofen and acetaminophen in patients with closed limb fractures: a randomized clinical trial

IntroductionThis study aims to investigate the effectiveness of intravenous ibuprofen or intravenous ibuprofen plus acetaminophen compared to intravenous morphine in patients with closed extremity fractures.MethodsA triple-blinded randomized clinical trial was conducted at a tertiary trauma center in Iran. Adult patients between 15 and 60 years old with closed, isolated limb fractures and a pain intensity of at least 6/10 on the visual analog scale (VAS) were eligible. Patients with specific conditions or contraindications were not included. Participants were randomly assigned to receive intravenous ibuprofen, intravenous ibuprofen plus acetaminophen, or intravenous morphine. Pain scores were assessed using the visual analog scale at baseline and 5, 15, 30, and 60 min after drug administration. The primary outcome measure was the pain score reduction after one hour.ResultsOut of 388 trauma patients screened, 158 were included in the analysis. There were no significant differences in age or sex distribution among the three groups. The pain scores decreased significantly in all groups after 5 min, with the morphine group showing the lowest pain score at 15 min. The maximum effect of ibuprofen was observed after 30 min, while the ibuprofen-acetaminophen combination maintained its effect after 60 min. One hour after injection, pain score reduction in the ibuprofen-acetaminophen group was significantly more than in the other two groups, and pain score reduction in the ibuprofen group was significantly more than in the morphine group.ConclusionThe study findings suggest that ibuprofen and its combination with acetaminophen have similar or better analgesic effects compared to morphine in patients with closed extremity fractures. Although morphine initially provided the greatest pain relief, its effect diminished over time. In contrast, ibuprofen and the ibuprofen-acetaminophen combination maintained their analgesic effects for a longer duration. The combination therapy demonstrated the most sustained pain reduction. The study highlights the potential of non-opioid analgesics in fracture pain management and emphasizes the importance of initiation of these medications as first line analgesic for patients with fractures. These findings support the growing trend of exploring non-opioid analgesics in pain management.Trial registrationClinicalTrials.gov Identifier: NCT05630222 (Tue, Nov 29, 2022). The manuscript adheres to CONSORT guidelines.

Using a mobile application to reduce potentially inappropriate prescribing for older Brazilian adults in primary care: a triple-blind randomised clinical trial

BackgoundPotentially inappropriate prescribing (PIP) has been evaluated in several countries, and several strategies have been devised for deprescribing drugs in older adults. The aim of this study was to evaluate the efficacy of a mobile application in reducing PIP for older adults in primary care facilities in Brazil.MethodsThis randomised, triple-blind, parallel-group trial was conducted in 22 public primary care facilities in Brazil. During the intervention phase, the general practitioners (GPs) were randomly allocated to the intervention (MPI Brasil app provides information about PIP, therapeutic alternatives and deprescribing) or control (MedSUS app provides general information about medications) group. All GPs were trained on the Clinical Decision-Making Process and how to access an Evidence-Based Health website. The GPs received an Android tablet with an installed mobile application depending on their allocated group, which they used when caring for older patients over at least 3 months. At the end of this period, a sample of older patients aged ≥ 60 years who had been awaiting medical consultation by the participating GPs were interviewed and their prescriptions analysed. The primary outcome was the frequency of PIP in and between the groups.ResultsAmong 53 GPs who were administered the baseline survey, 14 were included in the clinical trial. At baseline, 146 prescriptions were analysed: the PIP overall was 37.7% (55/146), in the intervention group was 40.6% (28/69), and in the control group was 35.1% (27/77). After the intervention, 284 prescriptions were analysed: the PIP overall was 31.7% (90/284), in the intervention group was 32.2% (46/143), and in the control group was 31.2% (44/141) (RR: 1.16; 95% CI, 0.76–1.76). In the within-group analysis, the PIP reduced from before to after the intervention in both groups—more significantly in the intervention than in the control group (p < 0.001). In the stratified analysis of PIP frequency by GPs, there was a relative risk reduction in 86% (6/7) of GPs in the intervention group compared to 71% (5/7) in the control group.ConclusionWe found that the MPI Brasil app effectively reduced PIP, suggesting that it may be useful to incorporate this tool into clinical practice.Trial registrationThe study was registered at ClinicalTrials.gov (NCT02918643). First registration on 22/09/2016.

Effects of Viola odorata syrup on sleep quality in menopausal women: a randomized, triple-blind, controlled trial.

The present study aimed to assess the effects of Viola odorata syrup on the sleep quality of postmenopausal women. This triple-blinded randomized clinical trial was conducted on menopausal women presenting to the healthcare centers in Mashhad, Iran, in 2019. The participants were selected using simple random sampling. Participants received 5ml syrup V. odorata or placebo twice a day for 1month. Data were collected using the Pittsburgh Sleep Quality Index. The data were analyzed using SPSS version 25. The 118 eligible women enrolled in the study were divided into two groups of V. odorata syrup and placebo (n = 59each). The analysis was conducted on only84 menopausal women (42 in each group)due to exclusions. Exclusions consisted of 12 participants whowithdrew from the study due to unwillingness to cooperate,8 who had irregularconsumption of the therapeutic syrup, 6 withinaccurate completion of the questionnaire, and 8 due to lack of accessibility. The two study groups were homogenous in terms of demographic characteristics. Before the intervention, no significant difference was observed in the mean PSQI scorebetween the two groups (9.2 ± 2.9 vs. 8.4 ± 2.5) (P = 0.18). However, a significant difference was seen in the mean PSQI scorebetween the two groups (4.9 ± 1.9 vs. 8.1 ± 2.1, P < 0.001) after the intervention. The findings of this study suggest that V. odorata syrup may be a useful therapeutic agent to improve the sleep quality of menopausal women. IRCT20180514039660N1.

Comparing Effectiveness and Safety of Intravenous Atropine with Topical Tetracaine in Preventing and Relieving Oculocardiac Reflex in Patients Undergoing Strabismus Surgery: A Randomized Clinical Trial

Abstract Background: Oculocardiac reflex (OCR) is one of the serious complications following surgical therapeutic procedures for strabismus. Various medications have been tested to prevent or mitigate this complication. We aimed to compare the effect of intravenous atropine and topical tetracaine on the incidence and severity of OCR in strabismus surgery. Materials and Methods: In this triple-blind randomized clinical trial study, 120 patients who were candidates for strabismus surgery were randomly assigned to receive intravenous atropine, topical tetracaine, or artificial tears as the control. The incidence of OCR and its severity along with the changes in hemodynamic conditions were compared across the groups. Results: The incidence rate of OCR in the groups receiving atropine, tetracaine, and the control was found to be 17.5%, 25.0%, and 32.5% in the releasing phase without any difference, respectively (P = 0.303); however, it was 2.5%, 7.5%, and 25.0%, respectively, in the cutting phase, indicating a lower rate in the group receiving tetracaine (P = 0.004). Similarly, there was no difference in the severity of OCR across the three study groups in the releasing phase (P = 0.666); however, in the cutting phase, OCR was revealed to be milder in the group receiving atropine as compared to other groups (P = 0.033). Prescribing atropine led to higher mean systolic blood pressure and mean arterial pressure during surgery. Conclusion: The injection of atropine can effectively reduce the incidence of OCR during strabismus surgery and reduce its severity if this reflex occurs.

A pilot study analyzing the influence of the material and the size of the orthodontic archwire on the level of pain and anxiety in adult patients in treatment with brackets: A prospective triple-blind randomized clinical trial.

The objective was to investigate the influence of the material and dimensions of the orthodontic archwire on the pain and anxiety in adult patients in orthodontic treatment with brackets. A randomized prospective triple-blind clinical pilot study was conducted at the Dental Clinic of the University of Salamanca. The study sample comprised 30 adult patients who started orthodontic treatment with brackets. This sample was divided into two groups: the NiTi group (n=15) and Cu-NiTi group (n=15). Pain was analyzed with a visual analogue scale (VAS) and anxiety with the State-Trait Anxiety Inventory (STAI). Anxiety was assessed at the start of treatment (T0) and after one month (T1). Pain was analyzed at the start of treatment (T0), at different time points at the start (T01), and after 4 (T02), 24 (T03), and 48 hours (T04); these measurements were also recorded one month after starting orthodontic treatment (T11, T12, T13, and T14). The mean age of patients was 31.3 (± 6.05) years old. The highest level of pain, at the beginning of treatment, was observed after 48 hours (5.57 ± 1.72) and at one month after starting treatment at 24 hours (5.13 ± 1.89), with no significant differences between the two groups. When analyzing anxiety, no differences were observed between groups; the anxiety levels were higher one month after starting treatment compared to the start. Regarding the correlation between pain and anxiety, the NiTi group showed a greater direct relationship (<0.05) between these two variables at the start of treatment in the anxiety trait in relation to pain at T02 and T03 and after a month in T12, T13, and T14. In the sample studied, there was no significant influence of the size or material of the orthodontic archwire on pain and anxiety levels. Key words:Orthodontics, Brackets, Archwire, Pain, Anxiety, NiTi, Cu-NiTi.

Change in dental caries status on provision of high fluoridated tooth paste; A triple blind randomized clinical trial.

Objective: To investigate the change in dental caries status on provision of high fluoridated tooth paste after 24 months. Study Design: Triple Blind Randomized Clinical and Controlled. Setting: Private School of Gulshan Town, Karachi. Period: January 2018 to January 2020. Material &amp; Methods: A cohort of regular school children aged 12-15 years studying in classes 6-9 were included. Through simple random sampling, 412 subjects were purposively allocated to Group A (n=202, intervention group) and Group B (n=210, control group). A pre-trial market survey was conducted to identify the fluoridated toothpastes available followed by the laboratory testing of fluoride concentration through Atomic Absorption Spectrometry. Dental examination was performed by a single examiner on mobile dental units under sunlight in the school ground using sterilized dental mirror, probe and tweezers at baseline and then after 8, 16 and 24 months employing the World Health Organization recommended Decayed Missing Filled Teeth index. Results: The mean age of the recruited participants was 12.91±0.82 having 209 males and 203 females. The mean DMFT scores observed over 24 months were 1.25 in group A and 1.42 in group B. At baseline it was 1.10 ±1.50 and 1.11±1.43 which gradually increased to 1.32±1.57 and 1.59±1.96 in group A and B respectively at last follow-up examination. Conclusion: This trial has identified no significant change in the overall dental caries status; however, the mean decayed score in both the interventional groups decreased on provision of high fluoridated tooth paste.

A tangible prospect for the treatment of gingivitis using a potentially probiotic strain Lactobacillus plantarum MK06 isolated from traditional dairy products: a triple blind randomized clinical trial

BackgroundFrequent bacterial plaque buildup at the gingival margin and crevice can provoke an inflammatory reaction in gingival tissues which manifests as gingivitis. Probiotics could serve as a beneficial complementary therapy for treating gingival inflammation. The main aim of this research was to investigate the effect of the Lactobacillus plantarum MK06 probiotic strain on the treatment of gingivitis.MethodsPatients with gingivitis, who were referred to a private clinic and were systematically healthy, were included in this randomized, triple-blind, placebo-controlled trial. They were instructed to use either placebo or Lactobacillus plantarum suspensions for one minute two times a day after tooth-brushing for four weeks. Then, the clinical parameters of gingivitis, including plaque index (PI), gingival index (GI), bleeding on probing (BOP), and oral hygiene index (OHI-s), were measured in the first, second, and fourth weeks. A total of forty-two patients were randomly assigned to the experimental (n = 21) and control (n = 21) groups. The mean age of the experimental and control groups was 29.10 and 28.48, respectively.ResultsThe mean scores of BOP, GI, PI, and OHI-s reduced over time in both the control and test groups. However, according to the Mann-Whitney test, the difference between the two groups was not significant at the same time intervals (P ≥ 0.05) and only GI showed a significant difference in the fourth week (GI-3, P = 0.006). Nevertheless, the experimental group experienced a higher overall reduction rate than the control group. The BOP, GI, PI, and OHI-s scores decreased by 0.081, 0.204, 0.186, and 0.172 times in the second week, respectively, resulting from the interaction of time and the intervention, which considerably diminished these indices.ConclusionThis study shows the potential of the probiotic Lactobacillus plantarum MK06 suspension as a promoting therapeutic adjuvant in the treatment of gingivitis.

Clinical performance of sealants under different humidity control conditions: a split-mouth 1-year randomized trial.

Sealants are an effective method of prevention and treatment for early caries lesions. This study analyzed the 1-year clinical performance of resin-based and ionomeric sealants applied to permanent teeth under different humidity conditions. The investigation was a triple-blind randomized clinical trial (RCT) with a four arms split-mouth design, divided according to the sealant protocol: (1) Resin-based sealant applied with rubber dam isolation, (2) Resin-based sealant applied with cotton rolls isolation, (3) Ionomeric sealant applied with rubber dam isolation and (4) Ionomeric sealant applied with cotton rolls isolation. Fifty-eight patients started the study (232 teeth), and 47 (188 teeth) remained until the 1-year recall. The modified USPHS criteria were used in the analyzes to investigate surface texture, retention and the presence of secondary caries lesions around the sealants; in the following periods: baseline, after 3, 6, 9, and 12months by two calibrated examiners. Data were analyzed by the Mann-Whitney and Friedman tests. There was no difference between the types of sealants (p > 0.05). The type of humidity control influenced the superficial texture (p = 0.0012) and the retention of sealants (p = 0.0023). The sealant displacement was greater under cotton rolls isolation. Only one active caries lesion in enamel was found in the 9th month. It may be concluded that sealants effectively prevented caries, even when they were partially or totally lost, regardless of the material. The rubber dam isolation with a rubber dam promoted lower surface roughness and improved the retention rates. International Clinical Trials Registry Platform: #1111-1215-2832 (07/26/2018).

Comparison of the effect of pressure control and volume control ventilation on endotracheal tube cuff pressure in patients undergoing general anesthesia and mechanical ventilation: a parallel randomized clinical trial

BackgroundEndotracheal intubation and mechanical ventilation are prevalent interventions in the operating room and intensive care unit. Recently, the complications of endotracheal tube cuff pressure have been a topic of interest. Therefore, this study compared the effect of pressure control and volume control ventilation modes on the endotracheal cuff pressure rate in patients undergoing general anesthesia and mechanical ventilation.MethodsIn this triple-blinded randomized clinical trial, 50 patients undergoing open limb surgery and inguinal hernia were allocated to two groups of 25 based on inclusion criteria. After intubation, one group underwent ventilation on the pressure control ventilation mode, and the other underwent ventilation on the volume control ventilation mode. In both groups, using a manometer, the cuff’s pressure was first adjusted in the range of 25–30 cm of water. Then, the cuff pressure was measured at 10, 20, and 30 min intervals. The data were statistically analyzed using independent t-test, and two-way repeated measures ANOVA.ResultsThe present study’s findings showed that cuff pressure has significantly decreased over time in both study groups (F = 117.7, P < 0.001). However, a repeated measures ANOVA with a Greenhouse-Geisser correction showed no interaction between time and groups (F = 0.019, P = 0.98). The two groups had no significant difference in cuff pressure (F = 0.56, P = 0.458).ConclusionSince the cuff pressure has been significantly reduced in both groups over time, continuous monitoring of endotracheal tube cuff pressure in patients undergoing mechanical ventilation is essential. Therefore, it is suggested to keep the cuff pressure within the recommended range to prevent complications resulting from cuff pressure reduction, such as aspiration and ventilation decrease.Trial registrationThe study was registered in the Iranian Registry of Clinical Trial on 23/02/2019 (trial registration number: IRCT20181018041376N1).

Therapeutic effects of topical cetirizine in the treatment of female pattern hair loss: a randomized controlled noninferiority trial

ABSTRACT Background Female pattern hair loss (FPHL) is the most prevalent form of hair loss in women. It was aimed to evaluate the therapeutic effects of topical cetirizine 1%, versus topical minoxidil 2% in patients with FPHL. Research design and methods Through a triple-blind randomized clinical trial, 60 women with FPHL were randomly divided into two groups of treatment with topical cetirizine 1% or topical minoxidil 2%. The endpoint was changing in hair loss severity as well as terminal hair density and diameter, according to trichoscopic evaluation. Intention-to-treat analysis was also performed for those who accomplished 3 months of treatment. Results Both groups showed improvement in hair diameter and density after 6 months; however, the outcome was significant only in the minoxidil group. According to per-protocol analysis, minoxidil was significantly superior to cetirizine in hair density, but not in hair diameter. According to the hair loss severity scales, FPHL was significantly improved in both the cetirizine and minoxidil groups after 6 months of therapy. The dropout rate due to adverse effects was 10.0% and 6.6% in the cetirizine and minoxidil groups, respectively. Conclusion Although inferior to topical minoxidil, topical cetirizine can provide favorable therapeutic effects for FPHL, specifically when patient incompatibility with Minoxidil is observed. Trial registration The study is registered in the Iranian Registry of Clinical Trials (IRCT) with the registration code IRCT20200521047536N1.

The Efficacy of Nigella sativa L. and Curcumin Nanomicelle Alone or Together on Lipid Profile, Glycemic Control Indices, and Serum 17-Β Estradiol in Postmenopausal Women.

Menopause is a condition for metabolic disorders. This study aimed to evaluate the effect of Nigella sativa (NS), curcumin nanomicelle (CN), lipid profile, glycemic status and 17-β estradiol (ES) levels in postmenopausal women. Triple-blind randomized clinical trial was conducted on 120 postmenopausal women. Participants were randomly assigned to four groups: 1) NS capsule 1000 mg and CN placebo, 2) 80 mg CN capsule and NS placebo, 3) both NS and CN capsules and 4) NS and CN placebo. Participants received a single dose daily for 6 months. The serum lipid profile, glycemic control biomarkers, and ES were measured pre-and post-intervention using biochemical methods. Total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, fasting blood sugar (FBS), fasting insulin (FI), insulin resistance (IR), and ES showed significant improvement in NS group. CN significantly reduced TC, FI, and IR, and significantly increased ES. The combination of NS-CN significantly decreased TC, LDL, FI, and IR, and increased HDL and ES. The comparison of the studied with the placebo groups showed that these changes were significant in glycemic indices and NS significantly increased estrogen. NS, CN and NS-CN improved lipid profiles, blood sugar, and hormone levels. However, this improvement was significant in glycemic indices and estrogen levels compared to the placebo group. No superiority of combined NS-CN over NS or CN was found in this trial.

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).