Abstract

Introduction: Depression is a disorder of major public health importance. The widely prescribed antidepressants of modern science are falling short in effectively managing the depression. Recent studies reported that depressive patients prefer to use other treatment options like complementary and alternative medicine (CAM therapies). Although systematic reviews on this topic have been published for CAM therapies; however, exclusive to Ayurveda interventions has not been performed till date. Therefore, the present study is intended to do a systematic review of the published clinical data in view of safety, efficacy, or effectiveness of Ayurvedic interventions in the management of depression and meta-analysis of eligible studies will be carried out, if appropriate. Materials and methods: A systematic review of randomized controlled trials (RCTs), multiple arms clinical trials, trial quasi-experimental trials (nonrandomized controlled clinical trials and before after studies), and observational studies (case series and case reports) will be performed through databases like PubMed, Cochrane Library (Cochrane Central Register of Controlled Trials: Issue 6 of 12, June 2018), AYUSH Research Portal (Govt. of India), DHARA, Google Scholar, and Online clinical trials registers. Studies published from the date of inception till the date the searches are run will be sought. The selection of the studies, data abstraction, and validations will be performed independently by the reviewers and any disagreements will be discussed by the team with fourth reviewer to reach consensus. Established guidelines for study selection, quality assessment, and narrative synthesis will be followed. Risk of bias assessment will be performed with the help of Cochrane risk-of-bias tool for randomized trials (RoB2) tool for RCTs and risk of bias tool to assess nonrandomized studies of interventions (ROBINS-I) tool for non- RCTs (NRCTs). Results of the study will be narratively synthesized and presented in count, percentage, and frequency and meta-analysis will be planned if they are sufficiently homogeneous. Patients will not be involved in any phase of the study; however, ethical approval has been obtained from the Institutional Ethics Committee. Dissemination: The systematic review will be published in a peer-reviewed journal and will also be disseminated electronically and in print. The review may guide healthcare practices and policy framing regarding the treatment of depression with Ayurvedic interventions. Study registration no: PROSPERO-CRD42020139382.

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