Triple-blind Randomized Clinical Trial Research Articles

Comparison of Two Oral Pastes Containing Triamcinolone and Rhus Coriaria L. for Treating Minor Aphthous Lesions

BackgroundRecurrent aphthous stomatitis (RAS) is a common oral mucosal lesion. Herbal medicine has been explored to treat this condition. This study compared the effectiveness of two oral pastes containing Triamcinolone and Sumac, for the healing, size, and symptomatology of RAS. MethodsThis triple-blind randomized clinical trial included 60 patients with minor aphthous ulcers. Participants were informed about the study and provided consent. Exclusion criteria consisted of specific medical conditions and medication use. The patients were divided into three groups and received either Sumac adhesive gel, Triadent oral paste, or a placebo. Ulcer size was measured before and after treatment. The medication was prepared using carboxymethylcellulose-based gel and Sumac powder extract. The study was triple-blinded, and the groups were labelled as A, B, and C. Data analysis was performed using SPSS version 22, employing repeated measurement, student t test, Kolmogorov–Smirnoff, and one-way ANOVA for quantitative data. Statistical significance was set at P ≤ .05. ResultsA clinical trial involving 59 participants compared the Sumac, Triadent, and placebo groups. The Sumac group exhibited the shortest healing time, significantly reduced lesion size, and lower Visual Analog Scale scores. Triadent took the longest time to heal ulcers. ANOVA test indicated no significant difference in age and gender distribution. ConclusionThis clinical trial evaluated two oral pastes for treating aphthous ulcers and found that the Sumac group achieved faster healing and reduced lesion size compared to the Triadent and control groups. Sumac shows promise as a treatment option, but further studies are necessary to confirm its efficacy and safety. These favourable results support the use of herbal treatments and suggest their potential for broader utilization in managing diseases such as RAS.

The effect of astaxanthin after varicocele surgery on antioxidant status and semen quality in infertile men: A triple-blind randomized clinical trial.

Varicocele (VC) is widely recognized as a prevalent etiological factor contributing to male infertility. It has been established that the generation of reactive oxygen species (ROS) plays a significant role in the progression and development of VC. Antioxidants may regulate ROS levels in these patients. Astaxanthin (ASX) is a carotenoid compound with notable antioxidant and anti-inflammatory characteristics. The current study postulated that the administration of ASX following varicocelectomy (VCT) could potentially enhance antioxidant status and semen quality in these patients. A total of 40 infertile males with clinical VC and abnormal semen analyses were randomly assigned to take part in the current trial. For 3 months following surgery, the intervention group took ASX (6 mg/day) while the control group received a placebo. After intervention, semen parameters, antioxidant status, and pro-inflammatory cytokines were compared between the two groups. Regarding semen parameters, antioxidant treatment led to a significant improvement in total and progressive motility in the treatment group (p < 0.05). Additionally, ASX led to a considerable increase in the expression levels of NRF2, Keap1, SOD2, SOD3, and BCL2, though the enhancement in the expression level of SOD3 was not statistically significant (p > .05). However, ASX significantly decreased the BAX expression level (p < .05). Even though the level of total antioxidant capacity (TAC) of seminal fluid (SF) increased significantly in the treatment group (p < .05), the level of total oxidative stress (TOS) in SF did not differ substantially between treatment and control groups (p > .05). Based on inflammatory factors in SF, ASX led to a considerable reduction in levels of TNF-α, IL-1β, and IL-6 (p < .05). Our findings demonstrated that ASX treatment provides an important contribution to VCT outcomes by modulating antioxidant status and pro-inflammatory cytokines. Our results indicated that ASX may be beneficial as an adjuvant therapy for infertile men following VCT.

The impact of synbiotic on serum sCD163/sTWEAK, paraoxonase 1, and lipoproteins in patients with chronic heart failure: a randomized, triple-blind, controlled trial

Cardiovascular disease is one of the leading causes of death worldwide. Evidence suggests that alterations in the gut microbiome could play a role in cardiovascular diseases, including heart failure. The purpose of this study was to evaluate the effect of synbiotics on serum paraoxonase 1(PON1), soluble CD163/soluble TNF-like weak inducer of apoptosis (sCD163/sTWEAK), and lipid profile, which are involved in heart failure in patients with chronic heart failure. In this triple-blind randomized clinical trial, 90 eligible patients were included in the study. They were randomly assigned to receive one capsule (500 mg) of synbiotics or a placebo daily for ten weeks. Serum PON1, sCD163/sTWEAK, and lipid profiles were measured at the beginning and end of the study. The data were analyzed by SPSS 24, and the p-value < 0.05 was considered statistically significant. Among 90 patients who met the inclusion criteria, 80 completed the study. The primary outcomes showed a small effect on sTWEAK, with an adjusted standard mean difference (SMD) of 0.2. However, no significant changes were observed in sCD163/sTWEAK (SMD: 0.16). Secondary outcomes indicated no changes in PON1, total cholesterol (TC), or LDL-C levels. However, there was an increase in HDL-C levels (adjusted SMD: 0.46, 95% CI: 0.02–0.91) and a decrease in TG and TC/HDL levels (adjusted SMD: − 0.5 and − 0.3, respectively) in the synbiotic group. A favorable effect of synbiotics on sTWEAK, HDL, TG, and TC/HDL of patients with heart failure was observed, but no statistically significant effect was found on sCD163/sTWEAK, PON1, LDL, and TC factors.

TDCS-enhanced cognitive training improves attention and alters connectivity in control and somatomotor networks: A triple blind study

BackgroundExecutive dysfunction such as inattention or forgetfulness can lead to disruptions in a person's daily functioning and quality of life. Objective/HypothesisThis triple-blinded randomized clinical trial assessed the efficacy of bifrontal (over the forehead) transcranial direct current stimulation (tDCS) concurrent with cognitive training to improve cognitive performance in a healthy sample. MethodsFifty-eight participants were randomly assigned to one of three stimulation conditions (2 mA left anode–right cathode, 2 mA right anode–left cathode, or sham), which was administered with cognitive training tasks 3x/week over 12 weeks with assessments at baseline, midpoint (6 weeks), and post-training (12 weeks). We assessed cognitive performance, functional connectivity, and the influence of individual differences in training advancement. ResultsForty participants completed training. We found that at midpoint and post, all groups improved significantly on overall cognitive performance. The left anode group's attention & vigilance score improved significantly at post, but the other two groups did not. Greater attention training advancement predicted attention improvement by post, most notably in the left anode group. Finally, within-network connectivity decreased in the control network and increased in the somatomotor network across all groups. ConclusionsThese results suggest that, given cognitive training, the left anode montage is more effective at improving attention than the right anode montage and sham. Future research may focus on the application of the left anode montage during cognitive training to assess its effectiveness in improving cognition in neuropsychiatric disorders.

The effect of oral capsules containing Ocimum basilicum leaf extract on menopausal symptoms in women: a triple-blind randomized clinical trial

BackgroundMenopause, characterized by various physical and mental changes, is primarily caused by hormonal fluctuations, resulting in numerous complications. Recently, herbal treatments have gained significant attention for their minimal side effects compared to chemical drugs. This study aimed to investigate the effects of oral capsules containing Ocimum basilicum leaf extract (OBLE) on menopausal symptoms.MethodsThis placebo-controlled clinical trial study was conducted in 2020. The research focused on 60 menopausal women referred to Mashhad health centers. Eligible participants were administered either an OBLE 500 mg capsule or a placebo daily for 1 month. Menopause symptoms were evaluated using the Menopause Rating Scale (MRS) before, two weeks, and one month after the intervention. Data were analyzed using SPSS21, independent t, Mann–Whitney, and Friedman tests. A significance level of p < 0.05 was considered significant.ResultsThe independent t-test indicated that the mean (SD) scores of menopausal symptoms in both the OBLE and placebo groups were initially similar before the intervention (P = 0.141). Two weeks after the intervention, the menopausal symptom scores were 9.5 ± 3.5 and 11.2 ± 5.6 in the OBLE and placebo groups, respectively (P = 0.163, df = 58, t = 1.4). After one month, the menopausal symptom scores were 6.9 ± 0.3 in the OBLE group and 11.26 ± 0.6 in the placebo group (P = 0.001, df = 58, t = 3.4). This indicates a significant difference between the two groups one month after the intervention, compared to before and two weeks after the intervention. Additionally, there was a significant difference in the scores of the physical and somato-vegetative dimension between the intervention and placebo groups two weeks and one month after the intervention (P < 0.05).ConclusionThe study results suggested that taking OBLE capsules led to a decrease in the scores of menopausal symptoms. This indicates that OBLE can be considered as a safe and cost-effective medicinal plant for alleviating menopausal symptoms among women.

The effect of Cuminum cyminum on the return of bowel motility after abdominal surgery: a triple-blind randomized clinical trial

Background and objectivesConsidering the significant prevalence of ileus after abdominal surgery and the beneficial effects of Cuminum cyminum in digestive problems, this study aimed to examine whether Cuminum cyminum has any effect on the return of bowel motility after abdominal surgery.Materials and methodsIn this triple-blind clinical trial study, 74 patients undergoing abdominal surgery were assigned to the intervention and control groups using minimization methods. The patients in the intervention group consumed 250 mg capsules containing Cuminum cyminum extract 4 h after the surgery and another dose of the drug 1 h afterward. The patients in the control group consumed a 250 mg capsule containing starch as a placebo at hours similar to those in the intervention group. The instruments used to collect the data were a demographic questionnaire and a researcher-made checklist to assess bowel habits. The data were analyzed using SPSS-22 software.ResultsThe average time of gas passing in the intervention and control groups was 9.03 ± 3.41 and 11.72 ± 4.21 h, respectively. The defecation times in the intervention and control groups were 16.97 ± 5.02 and 26 ± 9.87 h, showing a significant difference between the two groups as indicated by the independent samples T-test (P > 0.001). Furthermore, abdominal pain, abdominal bloating, nausea, and vomiting were significantly less frequent in the intervention group compared to the control group as confirmed by Fisher’s exact test (P > 0.001).ConclusionAccording to the results, the consumption of Cuminum cyminum after abdominal surgery helps to reduce the time of gas passing, defecation, and the return of bowel motility. However, additional studies need to address the effectiveness of Cuminum cyminum by changing the time and duration of its use.

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.

The effect of Camellia sinensis ointment on perineal pain and episiotomy wound healing in primiparous women: A triple-blind randomized clinical trial.

Episiotomy is one of the most commonly performed procedures in obstetrics. complications of episiotomy are pain, bleeding, infection, pain in the sitting position, and difficulty in taking care of the baby. This study aimed to investigate the effect of Camellia sinensis ointment on perineal pain and episiotomy wound healing in primiparous women. This triple-blinded randomized clinical trial was conducted on 60 primiparous women who were referred to the maternity ward of Al-Hadi hospital in Shoushtar and Ganjovian hospital in Dezful, Iran, from 2020 to 2021. Participants were randomly assigned into two groups of intervention (Camellia sinensis extract ointment) and control (placebo) with a follow-up of 14 days. REEDA scale (redness, edema, ecchymosis, discharge, and approximation) was used to measure wound healing and the Visual Analog Scale (VAS) was used to measure the pain intensity. There was no significant difference between two groups before intervention in terms of sociodemographic characteristics, pain intensity, and episiotomy wound status. Scores of pain intensity and wound healing reduced on days 7, 10, and 14 post-intervention in the intervention group compared to placebo. There was a significant decrease between the groups of intervention and control in terms of the mean score of pain intensity (VAS scale) on day 10 (1.33 ± 0.71, 1.77 ± 0.93) and day 14 (0.73 ± 0.74, 1.13 ± 0.81) post-intervention (P < 0.05). Also, on day 14 post-intervention, there was a significant decrease between the groups of intervention and control in terms of the mean score of episiotomy wound healing (REEDA index) (0.53 ± 0.77, 1.77 ± 1.46) (P < 0.05). The GLM test was applied for repeated measures. REEDA index and VAS scale changed during different times (time-variable) (p < .001). But, the studied groups (group variable) and the studied groups (interaction effect of group * time) did not affect the changes in the REEDA index (p = .292, p = .306) and VAS scale (p = .47) during different times. Our study showed that Camellia sinensis extract ointment has a small effect on the healing process and pain reduction of episiotomy wounds. to confirm its effect, a study with a larger sample size should be conducted. This trial was registered in the Iranian Registry of Clinical Trials on 04/10/2019 with the IRCT ID: IRCT20190804044428N1. Participants were enrolled between 11 April 2020 and 20 January 2021. URL of registry: https://en.irct.ir/trial/41326.

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.