scholarly journals The efficacy of an Ayurvedic polyherbal formulation in the symptomatic management of mild COVID-19 cases: A double blind, randomized controlled trial

2021 ◽  
Author(s):  
Sanjib kumar Das ◽  
Durga Prasad Dash ◽  
Pradip Kumar Panda ◽  
Sandhya Sadana ◽  
Reddy M. Ravi Kumar ◽  
...  
Keyword(s):  
Health Care Systems ◽  
Controlled Trial ◽  
Complete Recovery ◽  
Symptomatic Treatment ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Entire Study ◽  
Study Duration ◽  
Care Systems ◽  
Asymptomatic Case

Abstract PurposeThe COVID-19 pandemic, caused by the SARS-CoV-2 virus has infected millions of people globally, overwhelming the pharmaceutical industry and health care systems. The resulting crisis has highlighted the need for modern and traditional medicine systems to work together to find effective solutions quickly. Modern systems of medicine are primarily oriented towards symptomatic treatment, whereas the traditional systems of medicine such as Ayurveda emphasize prevention as well as treatment.Patients and methodsNF2 is polyherbal Ayurvedic formulation consisting of 19 ingredients from 13 herbs. 50 patients with confirmed symptomatic or asymptomatic case of COVID-19, reporting to the study site were invited to participate in a double blinded, randomized placebo-controlled clinical trial. The study duration was around 3 months, and the intervention period for an individual patient was 10 days.ResultsSignificant improvements were observed in the NF2 arm in comparison to the placebo arm. On Day 5, the population in the NF2 arm showed a complete recovery from sputum formation, sore throat, headache and fever. By Day 10, 90-100% of the population in the NF2 arm showed a complete recovery from all symptoms, unlike the control arm.ConclusionNF2 facilitated a complete recovery from all clinical features of COVID-19 faster, when compared to the control. No side effects were observed during the entire study duration.

scholarly journals Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aziza Ajlan ◽  
Hassan Aleid ◽  
Tariq Zulfiquar Ali ◽  
Hala Joharji ◽  
Khalid Almeshari ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
De Novo ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

scholarly journals Effect of antenatal dietary myo-inositol supplementation on the incidence of gestational diabetes mellitus and fetal outcome: protocol for a double-blind randomised controlled trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055314
Author(s):  
Ibrahim Ibrahim ◽  
Hala Abdullahi ◽  
Yassin Fagier ◽  
Osman Ortashi ◽  
Annalisa Terrangera ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Controlled Trial ◽  
Tolerance Test ◽  
Dietary Advice ◽  
Controlled Clinical Trial ◽  
Oral Glucose ◽  
Double Blind ◽  
Registration Number

IntroductionGestational diabetes mellitus (GDM) affects 23.6% of Qatari women and is associated with maternal and perinatal morbidity and long-term risk of developing type 2 diabetes. A number of challenges exist with current interventions, including non-compliance with dietary advice, the reluctance of mothers to ingest metformin tablets or use insulin injections. These challenges highlight the importance of pursuing evidence-based prevention strategies. Myo-inositol is readily available as an US Food and Drug Administration-approved food supplement with emerging but limited evidence suggesting it may be beneficial in reducing the incidence of GDM. Further studies, such as this one, from different ethnic contexts and with differing risk factors, are urgently needed to assess myo-inositol effects on maternal and neonatal outcomes.Methods and analysisThis study is a prospective, randomised, double-blinded, placebo controlled clinical trial to either myo-inositol supplementation or placebo.We plan to enrol 640 pregnant women attending antenatal care at Sidra Medicine, Doha, Qatar, 320 in each arm. All participants will complete at least 12 weeks of supplementation prior to undertaking the Oral Glucose Tolerance Test at 24–28 weeks. The daily use of the trial supplementation will continue until the end of pregnancy. All outcome measures will be collected from the electronic medical records.Ethics and disseminationEthical approval for the study was obtained on 12 April 2021 from Sidra Medicine (IRB number 1538656). Results of the primary trial outcome and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberProspectively registered on 26 May 2021. Registration number ISRCTN16448440 (ISRCTN registry).

scholarly journals Treament and prevention of anemia with ferrous sulfate plus folic acid in children attending daycare centers in Goiânia, Goiás State, Brazil: a randomized controlled trial

2008 ◽  
Vol 24 (suppl 2) ◽  
pp. s259-s271 ◽  
Author(s):  
Maria Claret Costa Monteiro Hadler ◽  
Dirce Maria Sigulem ◽  
Maria de Fátima Costa Alves ◽  
Vinícius Montenegro Torres
Keyword(s):  
Folic Acid ◽  
Ferrous Sulfate ◽  
Controlled Trial ◽  
Acid Group ◽  
Hemoglobin Level ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Daycare Centers ◽  
Randomized Controlled

The objective of this study was to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid. A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goiás State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50µg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50µg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months. Baseline anemia prevalence was 56.1% (95%CI: 48.9-63.1). After treatment, anemia prevalence in the folic acid group (14%) was lower than in the placebo group (34.9%) (p = 0.02). After prophylaxis in the non-anemic children, the incidence of anemia did not differ between the groups, but there was an increase in hemoglobin level in the folic acid group (p = 0.003). Iron plus folic acid was effective for the treatment of anemia and improvement of hemoglobin level in non-anemic children.

scholarly journals Comparison of pharmacokinetics of omega-3 fatty acid supplements in monoacylglycerol or ethyl ester in humans: a randomized controlled trial

2020 ◽  
Author(s):  
Laurie Chevalier ◽  
Mélanie Plourde
Keyword(s):  
Plasma Concentration ◽  
Ethyl Ester ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Controlled Clinical Trial ◽  
Omega 3 Fatty Acids ◽  
Omega 3 ◽  
Post Dose ◽  
Double Blind ◽  
Omega 3 Fatty Acid

Abstract Background A diet low in omega-3 fatty acids (n-3 FA) results in low plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the two main long chain n-3 FA. n-3 FA supplements on the market are esterified in triglycerides (TG) or ethyl ester (EE); the latter is absorbed less than other esterification forms. The objective of this study was to test and compare the pharmacokinetics of n-3 FA esterified in monoacylglycerides (MAG), a predigested form, with the EE form. Methods This study was a randomized, double-blind, crossover, controlled, clinical trial. Ten men and ten women between 18 and 60 years old were recruited. Participants received a single oral dose of 3 g of n-3 FA esterified in EE or MAG. Eleven blood samples were collected over 24 h post-dose. Plasma total lipids were extracted, methylated, and analyzed using gas chromatography. Results After receiving the MAG form, plasma EPA and DHA peaked at a concentration 3 and 2.5 times higher, respectively, than with the EE form. When provided in MAG form, n-3 FA plasma concentration during the absorption phase was on average 3–5 times higher than in EE form. When n-3 FAs were provided esterified in MAG, their concentration 24 h post-dose was higher than in EE. Males had a lower n-3 FA plasma concentration than females when n-3 FAs were provided in EE but there was no sexe difference when provided in MAG. Conclusions Plasma concentration of DHA and EPA was higher when provided in MAG than EE form.

scholarly journals Influence of Cinnamon on Glycemic Control in Individuals With Prediabetes: A Randomized Controlled Trial

2020 ◽  
Vol 4 (11) ◽  
Author(s):  
Giulio R Romeo ◽  
Junhee Lee ◽  
Christopher M Mulla ◽  
Youngmin Noh ◽  
Casey Holden ◽  
...  
Keyword(s):  
Glucose Tolerance ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Cost Effective ◽  
Tolerance Test ◽  
Controlled Clinical Trial ◽  
Oral Glucose ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Favorable Safety

Abstract Context The identification of adjunct safe, durable, and cost-effective approaches to reduce the progression from prediabetes to type 2 diabetes (T2D) is a clinically relevant, unmet goal. It is unknown whether cinnamon’s glucose-lowering properties can be leveraged in individuals with prediabetes. Objective The objective of this work is to investigate the effects of cinnamon on measures of glucose homeostasis in prediabetes. Design, Setting, Participants, and Intervention This double-blind, placebo-controlled, clinical trial randomly assigned adult individuals meeting any criteria for prediabetes to receive cinnamon 500 mg or placebo thrice daily (n = 27/group). Participants were enrolled and followed at 2 academic centers for 12 weeks. Main Outcome Measures Primary outcome was the between-group difference in fasting plasma glucose (FPG) at 12 weeks from baseline. Secondary end points included the change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC) derived from the OGTT. Results From a similar baseline, FPG rose after 12 weeks with placebo but remained stable with cinnamon, leading to a mean between-group difference of 5 mg/dL (P < .05). When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG (P < .001) and of the 2-hour PG of the OGTT (P < .05). There were no serious adverse events in either study group. Conclusions In individuals with prediabetes, 12 weeks of cinnamon supplementation improved FPG and glucose tolerance, with a favorable safety profile. Longer and larger studies should address cinnamon’s effects on the rate of progression from prediabetes to T2D.

scholarly journals P0506PATTERNS AND OUTCOMES OF GLOMERULAR DISEASES IN ADULTS PRESENTING TO MANSOURA UNIVERSITY HOSPITAL: A SINGLE-CENTER PROSPECTIVE STUDY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Hoda M. M. Abd-Elaziz ◽  
Mohammed Kamal Nassar ◽  
Dina Abdallah Ibrahim ◽  
Nagy Sayed-Ahmed
Keyword(s):  
Health Care Systems ◽  
Complete Recovery ◽  
National Registry ◽  
Renal Recovery ◽  
University Hospital ◽  
Glomerular Diseases ◽  
Dialysis Unit ◽  
Care Systems ◽  
Stage Renal Disease

Abstract Background and Aims Glomerular diseases (GDs) impose a substantial burden on patients and health care systems, and they are considered a major cause of end-stage renal disease (ESRD) worldwide. Morbidity and mortality have shown to be substantially higher in patients with GDs than in the general population. In Egypt, there is yet no available national registry for GDs, and GDs outcome is not adequately studied. Therefore, it is of considerable interest to study patterns and outcomes of GDs in our locality. Method Patients with features suggesting GDs presenting to Mansoura nephrology and dialysis unit (MNDU) were recruited in this study between 1 July 2017 and 30 June 2018, and those with biopsy-proven GDs were prospectively followed up for a minimum of 6 months or until either death or reaching ESRD. ESRD was defined as initiation of long-term dialysis or eGFR persistently <15 ml/min per 1.73 m2 during follow up visits. Enrolled patients were subjected to through history taking and clinical examination. Biopsies were independently examined by two pathologists blinded to the clinical data. The study outcomes were to identify the GDs subtype frequencies, and to identify the frequency of those achieving either renal recovery, progression to ESRD or death from all-cause mortality. Logistic regression analysis was carried out to identify the potential predictors for renal recovery. Results Sixty-six patients (21 males and 45 females) with biopsy-proven GDs were included and completed the required period of follow up. The median age of the studied patients was 32 years (IQR 23 - 46.45). Fifty percent of the cases had hypertension and only one patient had was diabetic. The main indications for renal biopsy were unexplained kidney function decline (62%) followed by subnephrotic (23%) and nephrotic presentation (15%). Diffuse proliferative GN followed by MPGN and sclerosing GN were the most frequently encountered histopathological patterns. Primary and secondary GDs constituted 30.3% and 69.7% respectively. Lupus nephritis (LN) was the most common cause of secondary GDs and class IV LN was the most frequently encountered class accounting for 16 cases (51.6%) of patients with lupus. By the end of 6-month follow up, renal recovery was achieved in 30 patients (45.5%), 21 patients (31.8%) progressed to ESRD and 7 patients (10.6%) had died. Urban residency and total renal chronicity score were the most significant predictors of renal recovery. Conclusion Diffuse proliferative GN is the most common histopathological pattern, and secondary GDs, particularly those related to lupus, are more frequently encountered than primary GDs in our center. Unfortunately, quick complete recovery is not the rule and is possibly predictable by less chronic changes in biopsy.

scholarly journals Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033815
Author(s):  
Tian-tian Ma ◽  
Zhikai Yang ◽  
Sainan Zhu ◽  
Jing-hong Zhao ◽  
Yi Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peritoneal Dialysis ◽  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Controlled Trial ◽  
Psychological Status ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Restless Legs ◽  
Peking University

IntroductionRestless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).Methods and analysisThis is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.Ethics and disseminationThe study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.Trial registration numberNCT03817554

scholarly journals Dexamethasone for Morbidity After Subdural Electrode Insertion – A Randomized Controlled Trial

2003 ◽  
Vol 30 (4) ◽  
pp. 340-348 ◽  
Author(s):  
Ramesh L. Sahjpaul ◽  
Jeff Mahon ◽  
Samuel Wiebe
Keyword(s):  
Pain Relief ◽  
Postoperative Period ◽  
Controlled Trial ◽  
Intractable Epilepsy ◽  
Controlled Clinical Trial ◽  
Antiemetic Drug ◽  
Double Blind ◽  
Dexamethasone Group ◽  
Significant Difference ◽  
Limited Duration

Background:Invasive monitoring with subdural electrodes (SDE) for investigation of medically intractable epilepsy may be associated with undesirable immediate postoperative morbidity such as headache, nausea, vomiting, fever, and meningism. We undertook to evaluate the potential beneficial role of perioperative dexamethasone in reducing these symptoms.Methods:In a double-blind placebo controlled clinical trial 30 patients undergoing SDE insertion were randomized to receive either placebo or a course of dexamethasone beginning one hour prior to surgery and tapering to discontinue over 72 hours postoperatively. Pain, pain relief, nausea, nausea relief, temperature, and meningism were assessed regularly in the postoperative period, and analgesic, antipyretic, and antiemetic drug requirements were tabulated.Results:One patient was withdrawn from the dexamethasone group due to lack of data. With regards to postoperative pain, the direction of benefit favoured dexamethasone but a significant treatment by time interaction prevented further analysis of treatment effect. The dexamethasone group did have significantly lower temperatures and higher nausea relief scores. There was no statistically significant difference between the groups with regards to pain relief, nausea, and meningism scores. The beneficial effects of dexamethasone were delayed in onset, of limited duration, and not uniform over the observation period.Conclusion:Dexamethasone appears to have a role in reducing immediate morbidity following SDE insertion but its effect is not uniform in the postoperative period; it appears to be delayed in onset, and of limited duration. Further study is necessary to determine the ideal dosing schedule.

scholarly journals SINONASAL POLYPOSIS

2018 ◽  
Vol 25 (10) ◽  
pp. 1581-1586
Author(s):  
Farhan Salam ◽  
Ejaz Ahmad ◽  
Muhammad Salman Haider Qureshi ◽  
Muhammad Aslam Khan
Keyword(s):  
Nasal Polyposis ◽  
Controlled Trial ◽  
Chronic Inflammatory Disease ◽  
P Value ◽  
Entire Study ◽  
Sense Of Smell ◽  
Study Duration ◽  
Group A ◽  
Group B ◽  
Sinonasal Polyposis

Introduction: Nasal polyposis (NP) is a chronic inflammatory disease involvingmucous membrane in paranasal sinuses and nose. It presents as gelatinous, semitranslucent,smooth, pedunculated pear or round shaped masses comprising of inflamed mucosa thatout-pouches into nose. The available surgical options are Functional Endoscopic SinusSurgery (FESS) and Conventional Intranasal Polypectomy (CIP). The study aims to compareFESS and CIP in sinonasal polyposis patient in term of symptomatic improvement. StudyDesign: Randomized controlled trial. Setting: Department of head n’ neck surgery andOtorhinolaryngology, Pakistan Institute of Medical Sciences, Islamabad. Period: 01-01-2015 to20-08-2015. Methodology: A total of 84 patients presenting with nasal polyposis were enrolled.Out of these 84 patients, 42 patients were randomly selected for FESS (Group-A). Rest of the42 patients were selected for CIP (Group-B). All the information recorded on the Performawas entered and analysed using SPSS version 17. The entire study duration was 31 weeks.Regarding ethical consideration, the study was approved from ethics committee of hospital.Informed consent was obtained from the study participants. Moreover, confidentiality andanonymity of subjects was assured. The patients were followed-up for 2 months duration. Theentire study duration was about 8 months. Results: On the basis of scoring of nasal obstruction,in FESS Group-A, 32 (76.19%) patients had completely patent nose after two months and only10 (23.81%) patients had partially blocked nose. On the other hand in CIP Group-B, only 16(38.10%) patients had completely patent nose while 26 (60.90%) patients had partially blockednose after two months. The comparison of sense of smell between both groups also showedthat the outcome of Group-A was significantly (p-value = 0.000) better as compared to Group-B.The complete sense of smell was found present in 37 (88.10%) patients in group A in contrastwith 19 (45.23%) patients in group B. Conclusion: FESS seems to be a better treatment optionfor sinonasal polyposis than conventional intranasal polypectomy. However study with largerpopulation size and longer follow up duration is recommended to rationalize the results.

scholarly journals Levodopa+carbidopa in X-linked Dystonia Parkinsonism (XDP/DYT3/Lubag): A Randomized, Double-blind, Placebo-controlled Trial

2018 ◽  
Vol 52 (6) ◽  
Author(s):  
Roland Dominic G. Jamora ◽  
Rosalia A. Teleg ◽  
Cynthia P. Cordero ◽  
Rodelyn F. Villareal-Jordan ◽  
Lillian V. Lee ◽  
...  
Keyword(s):  
Rating Scale ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Intention To Treat ◽  
Oral Medications ◽  
Significant Difference ◽  
Scale Scores

Objective. X-linked dystonia parkinsonism (XDP) is an adult-onset, progressive and debilitating movement disorder described among Filipino males from Panay Island. The available oral medications have been ineffective. While chemodenervation with botulinum toxin A works and deep brain stimulation surgery is promising, these are not affordable for the vast majority of patients. Thus, we decided to look into the efficacy, safety and tolerability of levodopa+carbidopa (levodopa) versus placebo among patients with XDP. Methods. This was a double blind, randomized, placebo-controlled clinical trial. Patients were randomized to receive levodopa or placebo for 6 months. The dose was increased gradually until 1000 mg levodopa/day is reached or until side effects appear. Results. A total of 86 out of 94 randomized patients (91.5%) were included in the intention-to-treat cohort for the primary efficacy analysis. Nineteen patients (9 in levodopa, 10 in placebo) dropped out or were lost to follow up. There was no significant difference in the baseline and last visit Burke Fahn Marsden Dystonia Rating Scale and the part III of the Unified Parkinson’s Disease Rating Scale scores between levodopa and placebo. The most common adverse events in the levodopa group were increased movements, pain and nausea/ vomiting. Conclusion. While levodopa is safe and well-tolerated, it does not have any effect in alleviating the dystonia or parkinsonism in XDP

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