Double-blind Controlled Clinical Trial Research Articles

Effect of Statin Treatment on COVID-19 Patients’ Outcomes: A Randomized Double-blind Controlled Clinical Trial

Background: Statins may be protective against viral infection and have been suggested for the treatment of coronavirus disease 2019 (COVID-19). Objective: In this study, we aimed to evaluate the effect of atorvastatin on COVID-19 patients. Methods: Our study is a randomized double-blind controlled clinical trial that constitutes a population of COVID-19 patients admitted to Bu-Ali Sina Hospital in Qazvin, Iran, from May to August 2021. For the intervention and control groups, in addition to the national standard treatment, atorvastatin 40 mg tablet and placebo were daily administered for 7 days, respectively. A questionnaire including demographic characteristics, history of underlying diseases, vital signs, laboratory and imaging results, and outcome (alive, died) was completed on the first, third, and fifth days of hospitalization. Finally, the obtained data were analyzed by SPSS software, version 25. Findings: One hundred five patients with COVID-19 (62 females and 43 males, mean age 69 years) were studied. On days 3 and 5 after the intervention, no significant difference was observed between the groups in terms of vital signs, laboratory findings, hospitalization time, and need for intensive care unit hospitalization. However, 5.7% of patients in the atorvastatin group and 0% of patients in the control group died (P=0.243). Among the studied variables, C-reactive protein (P=0.227 vs P=0.002), blood urea nitrogen (P=0.055 vs P<0.001), and creatinine (P=0.598 vs P=0.013) decreased significantly in the statin group (no control group during days 0-5). Conclusion: There was no evidence about the harm and benefits of statin treatment during COVID-19 hospitalization.

Analgesia and stress attenuation of ultrasound-guided modified pectoral nerve block type-II with different volumes of 0.3% ropivacaine in patients undergoing modified radical mastectomy for breast cancer: A prospective parallel randomized double-blind controlled clinical trial.

A previous randomized clinical trial concluded that an optimal concentration of 0.3% ropivacaine could provide satisfactory analgesia for breast cancer patients undergoing modified radical mastectomy. We wondered if a smaller volume (30 ml vs. 40 ml) of 0.3% ropivacaine could still provide adequate analgesia in an ultrasound-guided PECS II block in modified radical mastectomy. We performed a prospective parallel randomized double-blind controlled clinical trial. Eligible patients were assigned to either the P30 or P40 group (30 or 40 ml of 0.3% ropivacaine, respectively). The skin area of hypoesthesia, anaesthetic plane determined with ultrasound, pain visual analogue scale (VAS), anaesthetic dosages, and complications were recorded. Serum levels of interleukin-1β and interleukin-6 were measured postoperatively. A total of 40 patients completed the trials, with 20 patients in each group. Although the skin area of hypoesthesia and the anaesthetic planes were significantly larger in the P40 group compared with the P30 group (p < 0.05), the VAS, analgesic and opioid doses, serum cytokine levels, anaesthetic toxicity, and complications had no significant differences between the two groups. Compared with 40 ml, 30 ml of 0.3% ropivacaine could provide adequate analgesia and reduce surgical stress in patients undergoing modified radical mastectomy for breast cancer.

Prospective Randomized Controlled Clinical Trial Comparing Hyperosmolar Saline to Standard Isotonic Irrigation Fluid for Arthroscopic Knee Surgery: Initial Clinical Outcomes.

Numerous in vitro studies suggest higher osmolarity irrigation fluids potentiate a chondroprotective environment, and a recent clinical study using hyperosmolar saline for shoulder arthroscopy reported potential clinical advantages. This prospective randomized double-blind controlled clinical trial was designed to assess initial clinical outcomes associated with use of a hyperosmolar irrigation solution in patients undergoing arthroscopic knee surgery. With institutional review board approval and informed consent, patients scheduled for arthroscopic knee surgery were randomized to surgery with either isotonic lactated Ringer's (273 mOsm/L) or hyperosmolar saline (593 mOsm/L) irrigation solution. Outcomes included perioperative blood pressure, knee girth, visual analogue scale (VAS) pain scores, and narcotic pain medication consumption. Forty-six patients underwent arthroscopic knee surgery with isotonic (n = 23) or hyperosmolar (n = 23) irrigation fluids. There were 11 males and 12 females (mean age = 44.0 years) in the isotonic cohort and 8 males and 15 females (mean age = 40.2 years) in the hyperosmolar cohort. There were no significant differences with respect to surgical duration (pump time) or amount of irrigation fluid used between the two cohorts. There were no significant differences with respect to change in knee girth, blood pressure, or VAS pain scores. However, patients treated with hyperosmolar saline consumed less narcotic medication on postoperative day 3 (4.0 ± 7.6 vs. 15.5 ± 17.4 mg, p = 0.01). The results of this randomized clinical trial suggest that a hyperosmolar irrigation solution is safe and relatively inexpensive for use in patients undergoing arthroscopic knee surgery and contributes to a reduction in initial postoperative narcotic pain medication consumption. A hyperosmolar saline irrigation fluid was not associated with any detrimental effects on the execution of the surgical procedure, postoperative pain, or periarticular fluid extravasation. Taken together with previous basic science, translational, and clinical studies, hyperosmolar saline irrigation fluid is promising alternative to traditional isotonic irrigation fluids for knee arthroscopy. This study is a prospective trial and reflects level of evidence I.

Effect of vitamin D treatment on magnesium levels in chronic hemodialysis patient; a double blind controlled clinical trial

Introduction: The homeostasis of magnesium (Mg) is impaired in chronic kidney disease (CKD) and it has been suggested that intestinal absorption of Mg may be affected by vitamin D status. 25-Hydroxy vitamin D or 25(OH)D deficiency is common in patients undergoing chronic hemodialysis; however the efficacy of nutritional vitamin D supplementation on Mg level in this population remains uncertain. Objectives: The aim of this study was to evaluate the effect of vitamin D treatment on Mg levels in chronic hemodialysis patients. Patients and Methods: This randomized clinical trial study was conducted on 69 chronic hemodialysis patients (mean age of 56.93 ±12.26 years) with serum 25-hydroxy vitamin D levels &lt;30 ng/mL. The patients were randomly assigned to one of treatment groups of oral vitamin D3- 50 000 units per week (n=35; experimental group) or 500 mg calcium D3 tablets, every 12 hours (n=34; control group) for three months. At the beginning and end of the treatment period, the levels of serum 25-hydroxy vitamin D and the levels of Mg, calcium, phosphorus and intact parathyroid hormone (iPTH) were measured in two groups. Results: In both groups, serum vitamin D levels increased significantly after treatment (P&lt;0.0001 for both groups), however after three months of treatment, in the experimental group the levels of vitamin D were significantly higher than the patients in the control group (57 ng/mL versus 28 ng/mL; P&lt;0.0001) and the median increase of vitamin D after treatment in the experimental group was significantly higher than the control group (40 ng/mL versus 10.5; P&lt;0.0001). Serum Mg levels before and after treatment were not significantly different between two groups (P=0.880 and P=0.434). In this study, we found no significant correlation between serum vitamin D level with serum Mg, calcium, phosphate, and parathyroid Hormone levels (P&gt;0.05). Conclusion: Our study shows that oral vitamin D therapy can increase 25(OH)D levels in maintenance hemodialysis patients without significant alterations in serum calcium, phosphate, magnesium and parathyroid hormone during a 12-week period. Trial Registration: Registration of trial protocol has been approved by the Iranian registry of clinical trial (#IRCT20210314050698N1; https://en.irct.ir/trial/55159, local ethical code# IR.SKUMS.REC.1397.181).

Antibacterial effect of an herbal toothpaste containing Bamboo salt: a randomized double-blinded controlled clinical trial

BackgroundThe inclusion of herbal antibacterial agents in the composition of toothpastes is becoming increasingly popular, due to lower side effects. The present study intended to investigate the antibacterial efficacy of a herbal toothpaste containing Bamboo salt on cariogenic oral bacteria.MethodsThe present double-blinded parallel randomized controlled clinical trial was conducted on 60 dental students (age range: 18–30). Following the baseline saliva sampling, the participants were randomly assigned into the case and control groups, to use the Bamboo salt herbal toothpaste and conventional non-herbal toothpaste, respectively. They were instructed to brush their teeth twice a day using the Bass technique. Saliva sampling was repeated after four weeks. The salivary counts of Streptococcus mutans and Lactobacillus at baseline and 4-week follow-up were determined and presented as the logarithm of colony-forming units per milliliter (log CFU/mL).ResultsA significant decrease in salivary Streptococcus mutans and Lactobacillus was observed using both toothpastes (*P < 0.001). The difference between the antibacterial efficacy of two toothpaste types on Streptococcus mutans and Lactobacillus was not statistically significant (P = 0.530, and P = 0.137, respectively).ConclusionDue to the comparable efficacy of the investigated herbal toothpaste with conventional toothpaste, it potentially qualifies as a complementary agent for self-care oral hygiene procedures.Trial registration: This trial was registered in the “Iranian Registry of Clinical Trials” (IRCT20210414050964N1) on 21/06/2021.

The Impact of Trimetazidine on Cardiac Fibrosis, Inflammation, and Function in Ischemic Cardiomyopathy Patients

BackgroundPrevious studies have shown that Trimetazidine (TMZ) improves vascular endothelial function and reduces the inflammatory process progression. However, limited data have been available regarding its effects on myocardial fibrosis following ischemia and causing left ventricular dysfunction.PurposeTo investigate the impact of TMZ adjuvant therapy for ischemic cardiomyopathy (ICM) on cardiac fibrosis, vascular endothelial function, inflammation, and myocardial functions.MethodsThis randomized, double-blind controlled clinical trial included 48 patients (aged 59.4 ± 9 years) with ICM who were randomly assigned to two groups: TMZ 35 mg twice daily and placebo in addition to conventional ICM medications. All patients received the tablets for 3 months. Both groups were then compared in terms of connective tissue growth factor (CTGF), endothelin-1 (ET-1), tumor necrosis factor-alpha (TNF-α), and some echocardiographic indices, weekly angina attacks and nitrate consumption before and after treatment.ResultsNo significant differences between CTGF, ET-1, and TNF-α levels, in addition to some echocardiographic indices, were observed between both groups before treatment. After treatment, the TMZ group had significantly lower ET-1 than the placebo group, with both groups exhibiting a substantial decrease in TNF-α and CTGF. The TMZ group had lower mean ± SD levels for TNF-α and CTGF and showed significant improvement in echocardiographic indices and weekly angina attacks after treatment.ConclusionAdjunctive TMZ therapy for ICM effectively improved vascular endothelial function and reduced inflammation. Furthermore, our exploratory findings may be used to provide new information on the potential effects of TMZ on myocardial fibrosis by downregulating CTGF.

Effect of a low dose of empagliflozin on short-term outcomes in type 2 diabetics with acute coronary syndrome after percutaneous coronary intervention.

Objectives:To study the effects of low dose of empagliflozin on improving outcomes in diabetic patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI).Methods:This double-blind controlled clinical trial was carried out on 93 diabetic patients (56 males and 37 females, mean age of 56.55 years) with ACS who underwent PCI at 2 university teaching hospitals in 2020, Ahvaz, Iran. The patients were randomly assigned to receive empagliflozin (10 mg once daily) or placebo at similar doses for 6 months after PCI. In addition, to standard treatments with another hypoglycemic agent. Cardiovascular outcomes (including all-cause mortality, coronary revascularization, rehospitalization due to unstable angina, hospitalization due to heart failure, cardiovascular death, non-fetal myocardial infarction, and non-fetal stroke) were evaluated during period of 6 months follow-up after the empagliflozin treatment.Results:There was no significant difference between the low dose empagliflozin and placebo groups after treatment in terms of cardiovascular mortality (2.2% versus [vs.] 4.2%; p=0.598), rehospitalization due to unstable angina (4.5% vs. 8.7%; p=0.433), and coronary revascularization (2.2% vs. 0%; p=0.312).Conclusion:The results of this study showed that adding low dose empagliflozin to standard care of ACS diabetic patients after PCI was associated with no significant reduction in negative cardiovascular outcomes during 6 months.

The Effect of Pimpinella anisum on Treatment and Recurrence of Menopausal Hot Flashes: A Randomized, Controlled, Multicenter, Double-Blind, Parallel-Group Clinical Trial

Background: Considering the high prevalence of hot flashes and the controversies in its treatments, the present study evaluated the effect of Pimpinella anisum extract on the treatment and recurrence of hot flashes in women referred to the health centers of medical sciences universities in Tehran, Iran in 2019. Methods: The present double-blind controlled parallel-group clinical trial included 72 menopausal women with chief complaint of hot flashes. The participants were randomly assigned into two equal groups (n = 36 each) of experimental (receiving three P. anisum capsules) and control. The severity and frequency of hot flashes were measured by Visual Analogue Scale (VAS) before the treatment, eight weeks after the treatment, and four weeks after discontinuation of the medication. The data of patients, including their diet, were recorded in the questionnaires and information forms. The data were analyzed using SPSS 19, and the intra-group results were analyzed using the repeated measures analysis of variance (ANOVA). Also, to compare the scores between the groups, t-test, and Mann-Whitney-Wilcoxon (MWW) were used. Results: The frequency of hot flashes in the P. anisum group was 7.89 ± 5.67 before the treatment, 1.04 ± 1.24 eight weeks after the treatment, and 4.21 ± 2.03 in the four-week follow-up period. The severity of hot flashes among the P. anisum group was 11.50 ± 9.78, 1.90 ± 2.77, and 5.78 ± 1.92 before the treatment, eight weeks after the treatment, and four-week follow-up (P = 0.001), respectively. However, the severity and frequency of hot flashes did not change significantly in the placebo group (P = 0.75). No side effects were seen in any of the groups. Conclusions: Pimpinella anisum was effective in reducing the frequency and severity of hot flashes.

Antioxidant effects of astaxanthin and metformin combined therapy in type 2 diabetes mellitus patients: a randomized double-blind controlled clinical trial.

Background and purpose:Since the critical role of oxidative stress in the pathogenesis and complications of type 2 diabetes mellitus (T2DM) has been proven, antioxidant therapy is considered an applicable strategy to control T2DM development. This study aimed at evaluating the effect of astaxanthin (AST) supplementation combined with metformin on oxidative indices and antioxidant defenses in T2DM patients.Experimental approach:In this randomized, double-blind placebo-controlled trial, 50 T2DM subjects receiving metformin were supplemented with 10 mg/day AST or placebo for 12 weeks. Malondialdehyde concentration and serum total antioxidant capacity (TAC) were assessed as oxidative indices. We also evaluated NF-E2-related factor2 (Nrf2) as the most critical transcription factor of antioxidant defense. Moreover, the activity of antioxidant enzymes, superoxide dismutase (SOD), and catalase were calculated.Findings/Results:AST supplementation-metformin combination caused a significant increase in SOD and catalase activities, as well as inducing Nrf2 protein expression compared to the placebo group. Significant changes in serum malondialdehyde and TAC between the AST group and placebo group after supplementation were not observed, although a significant increase was observed in TAC within the AST group after supplementation (32.67 ± 6.73) to before (25.86 ± 5.98). These results remained without change after adjustment for potential confounders.Conclusion and implications:Our study demonstrated that AST supplementation controlled oxidative stress through a synergistic effect with metformin and ameliorated overall antioxidant capacity by inducing Nrf2 transcription factor and activating SOD and catalase in T2DM patients. As a result, AST and metformin combination therapy can be considered beneficial in modifying oxidative stress and preventing T2DM complications.

The effect of short-term omega-3 fatty acids supplementation on appetite in healthy men: A randomized double-blinded controlled clinical trial

Controlling mechanisms of appetite and food intake is an important issue for a variety of different types of athletes. Previous studies showed omega-3 fatty acid increased appetite in patients, but results in healthy individuals are inconclusive. This study assessed the effect of omega-3 fatty acid supplements on food intake and appetite in young male athletes with normal body fat percentage. In a three-week double-blind placebo-controlled RCT in Tabriz, Iran (2019), 72 male athletes, age 22.2 (±2.5) y with 13.9 (8.5) body fat percent were randomized to either an omega-3 (2000mg/day; EPA: 360mg, DHA: 240mg) or placebo (2000mg/day paraffin) group. 3-day food diaries were completed before and after the intervention. Body composition was measured by bioelectrical impedance analysis. Appetite was assessed by visual analog scale (VAS) before and after each week of intervention. Results showed carbohydrate intake increased in the omega-3 group (MD=65.8g; 95% CI=9.1, 70.1; P=0.03). VAS score for satiety decreased. Hunger sensation, desire to eat, and desire to eat sweet foods increased in each of the three weeks. In conclusion, our findings showed that omega-3 supplementation increased appetite in healthy athletes without significant change in body fat percentage. Further research is needed to generalize the results to other populations.

Therapeutic Effect of Multi-Channel Transcranial Direct Current Stimulation (M-tDCS) on Recovery of Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors-A Randomized Controlled Trial Protocol.

Background:There has been rapid drift of rehabilitation professionals toward the clinical use of technology aided electrical interventions. Brain is a cortical hub of functionally related neural connections. Motor learning entails strong interaction with the cognitive domains. So better outcomes may be expected by optimally targeting functionally correlated areas simultaneously through tDCS.Aim:To determine the therapeutic effect of Multi Channel tDCS in combination with Functional electrical stimulation, SaeboFlex and conventional rehabilitation on recovery of Cognitive Domains, Motor Functions of Paretic Hand, and Gait in individuals with subacute Stroke.Methods:This is prospective, randomized, double blind controlled clinical trial. Subacute Stroke Survivors with the age Group (40-75 years) will constitute the Population of the study. Participants will be randomly allocated to experimental or control group. Participants of Experimental group will receive Multi channel tDCS, Functional electrical stimulation, Saebo Flex Training and conventional rehabilitation. Participants of the group B will receive FES, training with SaeboFlex, conventional physiotherapy intervention similar to as given to the participants of group A and sham multi channel tDCS.Outcome Measures:The primary outcome measures of the study will be Fugl Meyer assessment, Electroencephalogram and secondary outcome measures of the study will be Grip strength, Pinch strength, Nine hole peg test( NHPT), Wisconsin gait scale, Montreal cognitive assessment, Electroencephaloraphy to observe the cortical changes and tDCS adverse effect questionnaire and stroke specific quality of Life scale.Statistical Analysis:The primary analysis of the study will be done at the end of 4 weeks. Statistical analysis of data will be done using SPSS Version 22 with the help of a statistician.Conclusion:An insight into the therapeutic interventions augmenting, cognitive and motor domains simultaneously may yield better outcomes in the field of stroke rehabilitation thereby improving quality of life of stroke survivors

Investigating the Effect of Zinc on the Prevention of Acute Peripheral Neuropathy in Cancer Patients Treated with Taxanes.

Background:Chemotherapy-induced peripheral neuropathy (CIPN) is a major complication of many chemotherapeutic agents, including taxanes. Here, we aimed to investigate the effect of zinc on CIPN.Materials and Methods:This is a double-blinded controlled clinical trial that was performed in 2020–2021 in Isfahan on 55 cancer patients. We collected the data regarding CIPN, its severity, presence of abnormal deep-tendon reflexes, paresthesia, restriction in daily activities, and restriction in self-care and pain. Patients were divided into two groups: Patients in the first group were treated with capsules of zinc sulfate 25 mg daily and the control group received placebo. The duration of treatments was 3 months. Patients were visited 6, 9, and 12 weeks after study initiation.Results:There was a statistically significant decrease in the frequency of CIPN in the intervention group (37.03% vs. 14.8%, P < 0.001). The evaluation of the severity of neuropathy and presence of abnormal deep-tendon reflexes also demonstrated significant decrease in the intervention group during the study (P < 0.001 for both), but no significant changes were observed in the placebo group (P > 0.05). The activity limitations and pain severity improved significantly both in the intervention and placebo groups (P < 0.001 for both groups and items). The intervention group, however, had significantly lower frequencies of activity limitation and lower pain severity within compared to the control group during the study (P < 0.001).Conclusion:Zinc supplement therapy resulted in reduced frequency and intensity of CIPN in patients undergoing chemotherapy with taxanes.

Effect of herbal cream containing Fumaria officinalis and silymarin for treatment of eczema: A randomized double-blind controlled clinical trial.

Objective:Atopic dermatitis (AD) is a common skin disorder with symptoms including severe pruritus and eczematous lesions. AD affects between 5 and 20% of people in their life. Silymarin (SM) is a polyphenolic flavonoid from Silybum marianum L. and has several therapeutic characteristics including antiallergic, anticancer, and anti-inflammatory properties. Fumaria officinalis is a small plant that has a high antioxidant power and modulating effects on the immune system. Therefore, the current study intended to examine the influence of these two herbs extract on severity and symptoms of AD in patients.Materials and Methods:40 patients with mild to moderate eczema randomly received mometasone 0.1% or the herbal cream. Treatment course was 2 weeks and patients were examined before and after 2 weeks of treatment using the SCORAD system.Results:The reduction of SCORAD score was significant in both groups (p=0.04 in the herbal group and p=0.03 in the mometasone group) but no significant difference was observed between the groups. Mean SCORAD score was 27.66±5.9 before therapy and 4.77±1.6 after therapy in the mometasone group and mean SCORAD score was 26.05±7.1 before therapy and 6.944±2.6 after therapy in the herbal group. Conclusion:The current study indicated the impact of these two herbs extract on severity and symptoms of AD in patients; these plants may be a new treatment in reducing eczema symptoms and its problems.

Relation of multimineral-vitamin D supplementation and the risk of preeclampsia

BackgroundThe objective of this study was to determine the favorable effects of multimineral-vitamin D supplementation on pregnancy outcomes among women at risk for preeclampsia.Patients and methodsThis randomized double-blind controlled clinical trial was conducted among 46 women at risk for preeclampsia at 27 weeks of gestation, with positive roll-over test. Pregnant women were randomly assigned to receive either the multimineral-vitamin D supplements (n = 23) or the placebo (n = 23) for 9 weeks. Multimineral-vitamin D supplements were containing 800 mg calcium, 200 mg magnesium, 8 mg zinc, and 400 IU vitamin D3. Fasting blood samples were taken at baseline and after 9-week intervention to measure related factors. Newborns' outcomes were determined.ResultsAlthough no significant difference was seen in newborns' weight and head circumference between the two groups, mean newborns' length (51.3 ± 1.7 vs. 50.3 ± 1.2 cm, P = 0.03) was significantly higher in multimineral-vitamin D group than that in the placebo group. Compared to the placebo, consumption of multimineral-vitamin D supplements resulted in increased levels of serum calcium (+0.19 vs. −0.08 mg/dl, P = 0.03), magnesium (+0.15 vs. −0.08 mg/dl, P = 0.03), zinc (+8.25 vs. −21.38 mg/dl, P = 0.001), and vitamin D (+3.79 vs. −1.37 ng/ml, P = 0.01). In addition, taking multimineral-vitamin D supplements favorably influenced systolic blood pressure (−1.08 vs. 6.08 mmHg, P = 0.001) and diastolic blood pressure (DBP) (−0.44 vs. 3.05 mmHg, P = 0.02).ConclusionsMultimineral-vitamin D supplementation for 9 weeks in pregnant women at risk for preeclampsia resulted in increased newborns' length; increased circulating levels of maternal serum calcium, magnesium, zinc, and vitamin D; and led to decreased maternal systolic blood pressure and diastolic blood pressure.

A systematic literature review of clinical trials and therapeutic applications of ibogaine

BackgroundIboga and its primary alkaloids, ibogaine and noribogaine, have been of interest to researchers and practitioners, mainly due to their putative efficacy in treating substance use disorders (SUDs). For many SUDs, still no effective pharmacotherapies exist. Distinct psychoactive and somatic effects of the iboga alkaloids set them apart from classic hallucinogens like LSD, mescaline, and psilocybin. AimsThe study team performed this systematic review focusing on clinical data and therapeutic interventions involving ibogaine and noribogaine. MethodsThe team conducted a search for all publications up to December 7, 2020, using PubMed and Embase following PRISMA guidelines. ResultsIn total, we identified 743 records. In this review, we consider 24 studies, which included 705 individuals receiving ibogaine or noribogaine. This review includes two randomized, double-blind, controlled clinical trials, one double-blind controlled clinical trial, 17 open-label studies or case series (including observational or retrospective studies), three case reports, and one retrospective survey. The published data suggest that ibogaine is an effective therapeutic intervention within the context of SUDs, reducing withdrawal symptoms and craving. Data also point toward a beneficial impact on depressive and trauma-related psychological symptoms. However, studies have reported severe medical complications and deaths, which seem to be associated with neuro- and cardiotoxic effects of ibogaine. Two of these fatalities were described in the 24 studies included in this review. ConclusionTreatment of SUDs and persisting comorbidities requires innovative treatment approaches. Rapid-onset therapies such as the application of ibogaine may offer novel treatment opportunities for specific individuals. Rigorous study designs within medical settings are necessary to warrant safe application, monitoring, and, possibly, medical intervention.

The effect of Aloe vera powder on anthropometric and metabolic syndrome’s indices in patients with type 2 diabetes: a randomized, double-blinded controlled clinical trial

PurposeIt is well accepted that diabetes is associated with heart diseases and hyperlipidemia as a risk factor. In traditional medicines, some herbs such as Aloe vera seem to be effective in controlling diabetes. Owing to lack of human studies, this study aims to examine the effect of Aloe vera consumption on fasting blood sugar (FBS), lipid profiles and body composition in type 2 diabetic patients.Design/methodology/approachThis double-blind, placebo-controlled trial study was conducted in 2019, in Shiraz, Iran. A total of 56 diabetic subjects were randomized by block randomization to receive a daily supplement of 1,000 mg Aloe vera powder capsules (n = 28) or placebo (n = 28) for eight weeks. At baseline and after eight weeks of treatment, dietary intake and physical activity were assessed by three-day food recall and international physical activity questionnaire. Meanwhile, after an overnight fasting, FBS and lipid profiles were measured. Blood pressure and anthropometric parameters were assessed in the beginning and the end of the study. Independent t-tests were used for between-group analysis and paired t-tests for within-group analysis.FindingsAfter intervention, weight, body mass index and waist circumference significantly decreased in comparison to the placebo group (p-value: < 0.001, 0.001 and 0.02). Although, FBS, total triglyceride and systolic blood pressure decreased significantly (p-value: 0.03, 0.001 and 0.01), no change has been seen in low density lipoprotein, high density lipoprotein and total cholesterol blood level and diastolic blood pressure.Research limitations/implicationsThe limitations of this study are the short study duration and lack of Aloe vera powder’s ingredient analysis.Originality/valueThis study is one of few human studies investigating the effect of Aloe vera on metabolic syndrome’s indices in diabetic patients. Because pharmacological therapy is tough, not comfort and correlated with potential adverse drug interactions, it is important to find an alternative or complementary measure to aid the diabetic patients. This study shows that Aloe vera has positive effect on body weight and blood sugar.

Evaluation of Comparative Efficacy of Brahmi vs. Haritaki Extract in the Management of Academic Stress in Adolescent Students- A Prakriti based Double-blind Randomized Controlled Trial

Introduction: Prevalence of mental illnesses among adolescents was found 7.3% (N=1191) by NMHS survey 2015-16 whereas the national crime record bureau in 2014 stated 1.8% of students committed suicide due to failure in their exams. The root cause, that is academic stress is often ignored which occurred due to various stressors like physical, mental, family, school, relationship, and social factors of which School factor (56.7%) and academic tests (45.6%) hold maximum association. Proper management can be provided with Ayurveda by Prakriti wise (exploring one physical, physiological and psychological factors) analysis of stress and their coping up strength and effect, when assisted with oral intakes of Ayurveda drugs like Brahmi and Haritaki along with Sattvavajaya Chikitsa having Achar Rasayana, Surya Namaskar, Dharna, and Dhyana practices.&#x0D; Aim and Objectives: The aim is to evaluate the comparative efficacy of Brahmi extract with Sattvavajaya Chikitsa over the effect of Haritaki extract with Sattvavajaya Chikitsa in the management of Academic Stress among adolescent students of different Prakriti.&#x0D; Material and Methods: A double-blind reference standard controlled stratified randomized superiority clinical trial is planned. The sample size of 198 participants with 13% dropout consideration will be enrolled after analysis of their Prakriti and stress level between 5-25 according to the SAAS scale. Total 6 subgroups (3 each for trial drug group and 3 for standard control) will have Vata, Pitta, and Kapha Doshic (V, P &amp; K) dominant Prakriti participants of 10 to 17years of age. Total 33 participants in each subgroup will have the interventions for 90 days.&#x0D; Observation and Results: Participants will be assessed for changes in salivary cortisol, level of academic stress, IQ, and memory before and after the trial. The standard descriptive and inferential statistical measures will be used to assess the effect of interventions.&#x0D; Conclusion: Prakriti analysis will help stressed adolescents to know their strengths and interventions provided will be expected to help a stressed one to minimize stress level and also assist in developing their stress-coping mechanism.

A comparison of intranasal dexmeditomidine versus intranasal midazolam as a pre anesthetic medication in children undergoing adenotonsillectomy

Abstract Background Adenotonsillectomy is one of the most common surgical procedures performed on pediatric patients. Relieving pre- and post-operative anxiety is an important concern for the pediatric anesthesiologist. Aim of the Work: to compare dexmedetomidine with midazolam effect on preoperative sedation, the ease of children parent separation, the mask tolerance, intraoperative hemodynamics stability, emergence of anesthesia and postoperative analgesia. Patients and Methods A Prospective, randomized and double blind controlled clinical trial was done after approval of institutional ethics committee in Ain Shams university Hospitals for 6 months and obtaining an informed written consent from parents. It was designed to include fifty pediatric patients, aged 5 to 10 years old of both genders, with physical status ASA Ι. Results statistically significant increase mean of Dexmedetomidine compared to midazolam according to sedation score after 15min. to after 45min. Conclusion Premedication with intranasal dexmedetomidine 1 μg/kg attained significant and satisfactory sedation with better parent separation and lower anxiety levels without any adverse effects as compared with intranasal midazolam 0.2 mg/kg in children undergoing adenotonsillectomy.

A Clinical Trial of Adding Morphine to Levobupivacaine in TAP Block for Open Appendectomy

Abstract Background Postoperative pain management is becoming an integral part of anaesthesia care. Various techniques of pain relief have been designed among which the most commonly practiced are peripheral nerve blocks. We have designed the study to assess analgesic efficacy, duration of postoperative analgesia, hemodynamic stability, and total need of analgesics and opioids after adding morphine to levobupivacaine in TAP block for open appendectomy. A substantial component of the pain experienced by patients after major abdominal surgery is derived from the abdominal wall incision. The abdominal wall consists of three muscle layers, the external oblique, the internal oblique and the transversus abdominis, and their associated fascial sheaths. This muscular wall is innervated by nerve afferents that course through the transversus abdominis neuro-fascial plane. Different adjuvants have been studied to improve the quality and increase the duration of local anaesthetics during various nerve block techniques. Aim of the work The aim of this study is to assess the analgesic effect of peripherally administered morphine with levobupivacaine for ipsilateral TAP block in patients undergoing appendectomy under general anaesthesia. Patient and Methods Type of Study prospective, randomized and double blind controlled clinical trial. Study Setting Ain Shams University Hospitals. Study Period 6 months. Sampling Method randomized double blind clinical trial. suction evacuation for molar pregnancy, all cases were included in the study were agreed on a consent for inclusion in the current study after explanation for the details of the study. Conclusion TAP block was effective in reducing postoperative pain scores, lowering total 24-h postoperative analgesic consumption. Morphine as an adjunct to levobupivacaine in ipsilateral ultrasound guided transversus abdominis plane block as more effective postoperative analgesia with reduced analgesic requirement in patients undergoing appendectomy.

A Clinical Trial to Assess the Role of Repetitive Transcranial Magnetic Stimulation in Smoking Cessation in an Egyptian Sample

Objective: The objective of this study was to assess whether repetitive transcranial magnetic stimulation (rTMS) increases the likelihood of smoking cessation after 6 months of treatment Methods: A randomized, double-blind controlled clinical trial is conducted by enrolling 54 tobacco users divided into 2 equal groups; one group receiving active rTMS and the other group receiving a sham rTMS. Both groups were followed up for 24 weeks after treatment for abstinence using the Nicotine Use Inventory, cigarette consumption, cravings by Arabic Tobacco Craving Questionnaire-12. Results: Fifty-four subjects received the full intervention and were analyzed. Carbon monoxide was significantly less in the study group after the last treatment session. At week 24, the percentage of point prevalence abstinent subjects was 25.9% in the active group and 18.5% in the sham group, however, the difference was not statistically significant. Arabic Tobacco Craving Questionnaire-12 measures at different time points showed a statistically significant decrease in emotionality, expectancy, and purposefulness measures. However, this appears to be due to the effect of time, not treatment. Treatment response was higher in the study group, yet the difference was statistically insignificant. Conclusions: In a study that simulates real-life conditions in Egyptian smokers, 6 sessions of high-frequency active rTMS over the left dorsolateral prefrontal cortex did not produce a statistically significant increase in abstinence over sham rTMS at the same site. However, an effect on carbon monoxide measures and treatment response warrants further research.