scholarly journals Botulinum Toxin for the Treatment of Focal Task-Specific Hand Dystonias: Systematic Review and Meta-Analysis

2019 ◽  
Vol 13 (1) ◽  
pp. 32-44
Author(s):  
Nigel Ashworth ◽  
Henry Aidoo ◽  
Alexander Doroshenko ◽  
David Antle ◽  
Charl Els ◽  
...  
Keyword(s):  
Systematic Review ◽  
Botulinum Toxin ◽  
Functional Performance ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Duration Of Symptoms ◽  
Ovid Medline ◽  
Focal Task

Objective:Botulinum Toxin (BTX) has become a widely used treatment in several dystonic conditions, but the evidence for its efficacy has largely come from open trials and expert opinion. This systematic review examined the efficacy and safety of BTX in the treatment of Focal Hand Dystonia (FHD) in Randomized Controlled Trials (RCTs).Methods:We searched Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE), Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, SPORT Discus, SCOPUS, Web of Science, PEDro, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) for randomized, placebo-controlled trials on the use of BTX for FHD.Results:Of 1,116 publications retrieved from the databases searched, three publications were included. The evidence identified pertains to focal task-specific hand dystonias. Sixty-nine participants were involved in the three RCTs with a mean duration of symptoms of 7.5 years. Participants were assessed using a combination of self-reported and functional performance outcome measures following injections of BTX subtype A (BTX-A) or placebo. The Oxford Quality Scale was used to assess the included studies, and the three studies each scored 3/5 or above. The included studies reported no adverse events with BTX-A use, other than muscle weakness and pain at the injection sites.Conclusion:The number of participants included in these three trials is too small to draw dependable conclusions about the efficacy and safety of BTX-A for FHD. There is currently not enough evidence to recommend the routine use of BTX-A for FHD.

scholarly journals The impact of inclusion, dose and duration of pyrazinamide (PZA) on efficacy and safety outcomes in tuberculosis: systematic review and meta-analysis protocol

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
James D. Millard ◽  
Elizabeth A. Mackay ◽  
Laura J. Bonnett ◽  
Geraint R. Davies
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Safety Outcomes ◽  
Meta Regression ◽  
Indirect Comparisons

Abstract Background Pyrazinamide (PZA) is a key component of current and future regimens for tuberculosis (TB). Inclusion of PZA at higher doses and for longer durations may improve efficacy outcomes but must be balanced against the potential for worse safety outcomes. Methods We will search for randomised and quasi-randomised clinical trials in adult participants with and without the inclusion of PZA in TB treatment regimens in the Cochrane infectious diseases group’s trials register, Cochrane central register of controlled trials (CENTRAL), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) international clinical trials registry platform. One author will screen abstracts and remove ineligible studies (10% of which will be double-screened by a second author). Two authors will review full texts for inclusion. Safety and efficacy data will be extracted to pre-piloted forms by one author (10% of which will be double-extracted by a second author). The Cochrane risk of bias tool will be used to assess study quality. The study has three objectives: the association of (1) inclusion, (2) dose and (3) duration of PZA with efficacy and safety outcomes. Risk ratios as relative measures of effect for direct comparisons within trials (all objectives) and proportions as absolute measures of effect for indirect comparisons across trials (for objectives 2 and 3) will be calculated. If there is insufficient data for direct comparisons within trials for objective 1, indirect comparisons between trials will be performed. Measures of effect will be pooled, with corresponding 95% confidence intervals and p values. Meta-analysis will be performed using the generalised inverse variance method for fixed effects models (FEM) or the DerSimonian-Laird method for random effects models (REM). For indirect comparisons, meta-regression for absolute measures against dose and duration data will be performed. Heterogeneity will be quantified through the I2-statistic for direct comparisons and the τ2 statistic for indirect comparisons using meta-regression. Discussion The current use of PZA for TB is based on over 60 years of clinical trial data, but this has never been synthesised to guide rationale use in future regimens and clinical trials. Systematic review registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019138735

scholarly journals Pharmacologic and Non-Pharmacologic Interventions for HIV-Neuropathy Pain. A Systematic Review and a Meta-Analysis

Medicina ◽  
2019 ◽  
Vol 55 (12) ◽  
pp. 762 ◽  
Author(s):  
Aikaterini Amaniti ◽  
Chrysanthi Sardeli ◽  
Varvara Fyntanidou ◽  
Panagiota Papakonstantinou ◽  
Ioannis Dalakakis ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Pain Control ◽  
Meta Analysis ◽  
Pain Reduction ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Pharmacologic Therapies

Background and Objectives: Among HIV infection symptoms, sensory neuropathy (HIV-SN) remains a main cause of suffering, with incidence varying from 13–50%. So far, numerous pharmacological and non-pharmacological treatments have been tested, although few evidence-based analgesic options are available. We conducted an up-to-date systematic review and meta-analysis of the literature in order to evaluate the efficacy and safety of pharmacologic and non-pharmacologic treatments for pain control, in patients with HIV neuropathy. Materials and Methods: We searched MEDLINE, EMBASE, Scopus/Elsevier, The Cochrane Central Register of Controlled Trials (CENTRAL), USA Clinical Trials registry, and The International Web of Science up to April 2019. All randomized controlled trials evaluating efficacy and safety of non-pharmacologic and pharmacologic therapies were included. Efficacy was defined as pain reduction during the study period. Safety was estimated from adverse events. A meta-analysis was performed whenever possible. Results: 27 randomized controlled trials (RCTs) were included for analysis (7 evaluating non pharmacologic interventions, 20 pharmacologic therapies). Non-pharmacologic studies (n = 742) involved seven different therapeutic modalities. Only Acupuncture/Moxibustion showed pain reduction over placebo, Gracely Pain Scale Mean (SD): Acu/Moxa 0.85 (0.12), placebo 1.10 (0.09), p = 0.05. Pharmacologic studies, involving 2516 patients revealed efficacy for capsaicin 8% over placebo (mean difference −8.04 [95% CI: −14.92 −1.15], smoked cannabis (where pooling data for meta-analysis was not possible) and recombinant Nerve Growth Factor. Conclusion: Despite various modalities for pain control in HIV-SN, strongest evidence exists for capsaicin 8% and smoked cannabis, although of low methodological quality. Among non-pharmacologic modalities, only Acu/Moxa gave a marginal beneficial effect in one study, possibly limited by inherent methodological flaws.

Comparative efficacy and safety of bone-modifying agents for the treatment of bone metastases in patients with advanced renal cell carcinoma: A systematic review and meta-analysis.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16067-e16067
Author(s):  
Kenji Omae ◽  
Yasushi Tsujimoto ◽  
Michitaka Honda ◽  
Tsunenori Kondo ◽  
Yasunobu Hashimoto ◽  
...  
Keyword(s):  
Systematic Review ◽  
Renal Cell Carcinoma ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety

e16067 Background: Bone-modifying agents (BMA) have been well-demonstrated to be effective for preventing and inhibiting skeletal-related events (SRE) in patients with bone metastases of breast or prostate cancer. However, the role of BMA treatment has not yet been clearly defined in patients with bone metastases of renal cell carcinoma (RCC). We, therefore, conducted a systematic review and meta-analysis to evaluate the efficacy and safety of BMA in patients with bone metastases of RCC. Methods: Literature search was conducted on MEDLINE, the Cochrane Central Register of Controlled Trials, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov to identify randomized controlled trials of BMA for the treatment of bone metastases in RCC patients. The primary outcomes were SRE and serious adverse events (AEs). Hazard ratios (HRs) were calculated with a random effects model. The Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach was used to assess the certainty of the evidence. This review was prospectively registered on PROSPERO (No. CRD42016032742). Results: Three studies (259 patients) were identified for the systematic review. Two studies that compared zoledronic acid with placebo or non-zoledronic acid showed that zoledronic acid reduced the SRE risk by 68% (HR 0.32; 95% confidence interval (CI) 0.19–0.55; P < 0.0001). The quality of evidence was moderate. No serious osteonecrosis was reported in both studies. The incidence of serious AEs was identical (80%) on both treatment arms in one study and not reported in the other study. In the remaining study, which compared denosumab with zoledronic acid, analyses of the individual patient data shared through Amgen showed a favorable trend for denosumab in terms of SRE (HR 0.71; 95% CI 0.43–1.17) and serious AEs (risk ratio 0.86; 95% CI 0.68–1.08), but this trend did not reach statistical significance. Conclusions: The moderate-quality evidence indicates that zoledronic acid significantly reduces the risk of SRE among patients with bone metastases of RCC.

scholarly journals Antihypertensive therapies in moderate or severe aortic stenosis: a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e036960
Author(s):  
Jonathan Sen ◽  
Erin Chung ◽  
Christopher Neil ◽  
Thomas Marwick
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Aortic Stenosis ◽  
Severe Aortic Stenosis ◽  
Meta Analysis ◽  
Left Ventricular ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Safety Outcomes

BackgroundHypertension confers a poor prognosis in moderate or severe aortic stenosis (AS), however, antihypertensive therapy (AHT) is often not prescribed due to the perceived deleterious effects of vasodilation and negative inotropes.ObjectiveTo assess the efficacy and safety outcomes of AHT in adults with moderate or severe AS.DesignSystematic review and meta-analysis.Data sourcesThe Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and grey literature were searched without language restrictions up to 9 September 2019.Study eligibility criteria, appraisal and synthesis methodsTwo independent reviewers performed screening, data extraction and risk of bias assessments from a systematic search of observational studies and randomised controlled trials comparing AHT with a placebo or no AHT in adults with moderate or severe AS for any parameter of efficacy and safety outcomes. Conflicts were resolved by the third reviewer. Meta-analysis with pooled effect sizes using random-effects model, were estimated in R.Main outcome measuresMortality, Left Ventricular (LV) Mass Index, systolic blood pressure, diastolic blood pressure and LV ejection fractionResultsFrom 3025 publications, 31 studies (26 500 patients) were included in the qualitative synthesis and 24 studies in the meta-analysis. AHT was not associated with mortality when all studies were pooled, but heterogeneity was substantial across studies. The effect size of AHT differed according to drug class. Renin–angiotensin–aldosterone system inhibitors (RAASi) were associated with reduced risk of mortality (Pooled HR 0.58, 95% CI 0.43 to 0.80, p=0.006), The differences in changes of haemodynamic or echocardiographic parameters from baseline with and without AHT did not reach statistical significance.ConclusionAHT appears safe, is well tolerated. RAASi were associated with clinical benefit in patients with moderate or severe AS.

scholarly journals Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 11 ◽  
Author(s):  
Huan Qian ◽  
Fangjie Shao ◽  
Cameron Lenahan ◽  
Anwen Shao ◽  
Yingjun Li
Keyword(s):  
Systematic Review ◽  
Depressive Symptoms ◽  
Botulinum Toxin ◽  
Randomized Controlled Trials ◽  
Clinical Diagnosis ◽  
Effect Size ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled

Background: Major depressive disorder (MDD) is a serious mental disorder that represents a substantial public health problem. Several trials have been undertaken to investigate the role of botulinum toxin type A (BTX-A) in the treatment of MDD, but the conclusions were controversial. To examine the efficacy and safety of BTX-A vs. placebo on patients with a clinical diagnosis of MDD, we conducted this systematic review and meta-analysis.Methods: A systematic search was conducted for all relevant randomized controlled trials (RCTs) in PubMed and Web of Science from inception to June 17, 2020. All published studies that investigated the efficacy and safety of BTX-A injections on patients with a clinical diagnosis of MDD were included. The overall effect size was summarized using a random-effects meta-analysis model. The primary outcomes of the present meta-analysis were the changes in depressive rating scale at week 6 after BTX-A injection compared with placebo. The safety of BTX-A injections also was assessed.Results: Five RCTs with a total of 417 participants (189 patients in the BTX-A group, 228 patients in placebo group) were eligible in this meta-analysis. The results indicated an overall positive effect of BTX-A injections for reducing the depressive symptoms of patients with MDD (Hedges' g, −0.82; 95% CI, −1.38 to −0.27) with large effect size. Differences are likely explained by the dose of BTX-As and the gender of the participants. Our findings also highlighted that BTX-A injections were generally well-tolerated, with only mild and temporary adverse events reported.Conclusions: The present meta-analysis provides evidence that BTX-A injections are associated with a statistically significant improvement in depressive symptoms. BTX-A injections are generally safe and may provide a new, alternative option for the treatment of depression.

scholarly journals Efficacy and safety of pre-exposure of antibiotic prophylaxis for leptospirosis: protocol of a systematic review and meta-analysis

2021 ◽  
Author(s):  
Benny Rashuaman-Conche ◽  
Silvana Loli-Guevara ◽  
Ethel Rodriguez ◽  
Carlos Alva-Diaz
Keyword(s):  
Systematic Review ◽  
Antibiotic Prophylaxis ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Public Health Problem ◽  
Controlled Trials ◽  
Antibiotic Administration ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: Leptospirosis is the most widespread zoonosis in the world. It represents a public health problem especially in tropical and subtropical regions, but it is also presents in temperate regions. Spirochetes from leptospira genus cause the disease, they affect humans as an intermediate host. About pre-exposure prophylaxis for people at risk, antibiotics such as doxycycline or azithromycin were used to prevent the development of leptospirosis and its related adverse outcomes. However, the evidence about the efficacy and safety of this intervention is limited. Objectives: To determine whether pre-exposure antibiotic administration prevents infection, hospitalization, or mortality from leptospirosis, without causing severe adverse effects. Methods: We propose to do a systematic review and meta-analysis. We will search in Pubmed (Medline), Embase.com, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Web of Science, LILACS and ClinicalTrials.gov. Individual randomized controlled trials, non-randomized controlled trials, cohorts, and cases-control studies will be included according to the inclusion and exclusion criteria set. The flow chart for selecting studies to be included will be presented in accordance with the PRISMA guide. The methodological quality of the studies will be evaluated by duplicate. Subsequently, the qualitative analysis of the data will be carried out and the feasibility of a quantitative meta-analysis will be evaluated. Finally, a summary of findings table will be presented according to the feasibility of the meta-analysis. Results: The results will be published in a peer-reviewed journal. Conclusion: This systematic review will sum up-to-date evidence about the efficacy and safety of pre-exposure antibiotic prophylaxis for preventing laboratory-confirmed leptospirosis, hospitalization and mortality.

scholarly journals Comparative efficacy and safety of probiotics for the treatment of irritable bowel syndrome: a systematic review and network meta-analysis protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e027376
Author(s):  
Man Yang ◽  
Yuanyuan Yu ◽  
Ping-Guang Lei ◽  
Jinqiu Yuan
Keyword(s):  
Systematic Review ◽  
Irritable Bowel Syndrome ◽  
Meta Analysis ◽  
Absolute Difference ◽  
Individual Species ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Comparative Efficacy ◽  
Irritable Bowel

IntroductionIrritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder affecting approximately 10% to 25% of the adult population. A large number of clinical trials have been conducted to evaluate the efficacy of probiotics for IBS but the results were inconsistent. Previous meta-analyses have shown that probiotics are effective for IBS, but the comparative efficacy of individual species is unclear. In addition, evidence regarding the superiority of combination over single probiotic is still lacking. We, therefore, perform this study to evaluate the comparative efficacy and safety of various species of probiotics, and combination regimens for the treatment of IBS.Methods and analysisThis study is a systematic review with network meta-analysis. We will search PubMed, Scopus, The Cochrane Central Register of Controlled Trials and CINAHL for randomised controlled trials comparing probiotics with placebo or comparing different probiotics for IBS, with no language restrictions. The primary outcomes will be treatment response and global IBS-symptom score. We will initially combine included studies with traditional pairwise meta-analysis and then with random-effects network meta-analysis. We will quantify the effect of potential effect modifiers by meta-regression if appropriate. We will check the consistency assumption by testing the absolute difference between direct and indirect estimates for comparisons in closed loops. The quality of evidence will be evaluated according to the GRADE framework.Ethics and disseminationEthical approval is not required for literature-based studies. We will disseminate the findings through publications in peer-reviewed journals and relevant conferences.PROSPERO registration numberCRD42018102101

scholarly journals Tian Wang Bu Xin Dan for Insomnia: A Systematic Review of Efficacy and Safety

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Xi-qian Yang ◽  
Ling Liu ◽  
Shu-ping Ming ◽  
Jie Fang ◽  
Dong-nan Wu
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Western Medicine ◽  
Random Sequence ◽  
Meta Analysis ◽  
Safety Information ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Insomnia Treatment

Background. The Traditional Chinese Medicine (TCM) Tian Wang Bu Xin Dan (TWBXD) has been used widely for treating insomnia in China. The purpose of this meta-analysis was to evaluate the efficacy and safety of TWBXD in the treatment of insomnia. Objective. This study evaluated the efficacy and safety of TWBXD for insomnia. Methods. We searched seven main databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Chinese Biomedicine Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wan-fang. We identified randomized-controlled trials (RCTs) for insomnia treatment involving TWBXD, TWBXD combined with conventional Western medicine, and conventional Western medicine from their inception to May 2018. The quality of literature was evaluated by Cochrane assessing tool to reduce the risk of bias. Meta-analysis and heterogeneity of results across the trials were performed. RevMan 5.3 was used to synthesize the results. Results. 14 studies involving 1,256 participants were identified in this systematic review. Methodological deficiencies existed in most of the included trials. Few studies described the generation of a random sequence in detail, the concealment of allocation, and the methods of blinding. No placebo was used in treatment. 12 trials compared TWBXD with conventional Western medicine and 2 trials compared TWBXD combined with conventional Western medicine. The results of our meta-analysis showed relative benefits in effective rates in favor of TWBXD (Odds Ratio [OR] 2.71, 95% confidence interval [CI] 1.67 to 4.39, P < 0.00001) and TWBXD combined with conventional Western medicine (OR 5.05, 95% CI 1.58 to 16.12, P=0.006). The Pittsburgh Sleep Quality Index (PSQI) scores showed similar results, which favored TWBXD (Weighted Mean Difference [WMD] -1.82, 95% CI -3.00 to -0.64, P=0.003). Only 5 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusion. This review demonstrates that although the effects of TWBXD on insomnia were promising, they need to be interpreted with caution, due to the poor methodological quality and the small number of trials of the included studies. TWBXD seems to be generally safe, but there is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further studies on a larger scale with more rigorous designs are required to evaluate the role of TWBXD in the insomnia treatment.

scholarly journals Efficacy and Safety of Ayush-64 as standalone or adjunct to standard care in COVID-19: A Structured Summary of Protocol for a Systematic Review

2021 ◽  
Author(s):  
Amit Kumar Rai ◽  
Azeem Ahmad ◽  
Pallavi Suresh Mundada ◽  
Krishna Kumar ◽  
Babita Yadav ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Studies ◽  
Standard Care ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Therapeutic Interventions ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Early Recovery

Abstract Background: Apart from vaccines, significant efforts have been made to develop prophylactic and therapeutic interventions against COVID-19. Lack of standard therapeutic options for the management of COVID-19 contributes to seriousness of this novel disease. The current strategy for exploring therapeutic interventions to manage this pandemic is broadly based on repurposing and repositioning of existing medications and recommending them for symptomatic support. In the early stage of COVID-19, the interventions that limit the progression of the disease and facilitate early recovery may play a significant role. AYUSH‑64 is a polyherbal Ayurveda formulation developed by the CCRAS, Ministry of Ayush, Government of India. It has been found effective and safe in various infective febrile conditions like malaria, microfilaremia, chikungunya, and influenza [1-5]. AYUSH‑64, was repurposed for the management of asymptomatic and mild to moderate COVID-19 based on the experimental and clinical outcomes indicating its potential benefits and safety in disease conditions like influenza‑like illness. Government of India recommended the use of AYUSH-64 to manage the asymptomatic and mild COVID-19 cases on the basis of outcomes of clinical studies on AYUSH-64 in COVID-19 [6,7]. In this context, this systematic review is planned to synthesize evidence related to the safety and efficacy of AYUSH-64 as standalone or adjunct to standard care in managing asymptomatic and mild to moderate COVID-19. Methods: The PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-analyses- Protocol statement) guidelines have been followed for drafting this protocol. All Randomized Controlled trials that assess the efficacy and safety of AYUSH-64 for the management of COVID-19 as standalone or adjunct to conventional standard care will be considered for this systematic review. Comprehensive search will be done for the published studies as per the pre-designed search strategy in the electronic databases such as AYUSH Research Portal’s “National Repository on AYUSH COVID-19 Clinical and Other R&D Initiatives”, PubMed, Cochrane Central Register of Controlled Trials, DHARA, IndMED, COVID-19 Evidence Alerts from McMaster PLUSTM, Epistemonikos, TRIP database, Google Scholar, National Collaborating Centre for Methods and Tools database of COVID-19 studies, Clinical Trial Registry of India and WHO dashboard for clinical trials related to COVID-19 from inception till October 2021. Data selection and extraction for each study will be performed independently by two review authors, with disagreements resolved by discussion with third review author/consensus. Risk of bias assessment will be performed using the revised tool to assess the risk of bias in randomized trials (RoB 2). The results will be quantitatively synthesized (meta-analysis) using Review Manager 5.4. If meta-analysis will not be conducive due to substantial heterogeneity, we will summarize and explain the results of the included studies as the systematic qualitative synthesis.Discussion: To date, this will be the first systematic review on the Ayurveda intervention, AYUSH-64 that will synthesize the evidence on its efficacy and safety in the management of COVID-19. The pilot search undertaken before planning this systematic review resulted in 07 clinical studies on AYUSH-64 that evaluate its efficacy and safety in the management of COVID-19. These search results justify the initiation of this systematic review. This systematic review will help the policy makers for its wider implementation in the management of asymptomatic and mild to moderate COVID-19. The results of this systematic review will be published in an indexed open-access journal to ensure wider dissemination.

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