Publication:

Scope of Ayurvedic interventions for insomnia: a systematic review protocol

Background Anidra (Insomnia), corresponding to the ICD-11 TM2 code SK02 and ICD-10/ICD-11 codes G47.00, F51.01, and 7A00, is a highly prevalent global disorder affecting 10–30% of the population, with significant impacts on mental health and quality of life. Current pharmacological treatments are limited by side effects and tolerance, and although Ayurveda offers a comprehensive range of pharmacological and non-pharmacological therapies for insomnia, the existing evidence remains scattered and inadequately synthesized.

Methods This systematic review will evaluate and synthesize the methodological quality, safety, and effectiveness of Ayurvedic interventions for insomnia. Randomized controlled trials, comparative clinical trials, non-randomized controlled trials, and quasi-experimental studies involving adolescents and adults with insomnia (Anidra/Nidranasha), assessed using validated scales (ISI, PSQI) or objective sleep parameters (SOL, TST, SE%), will be included. Comparators will include standard care (hypnotics, CBT-I), placebo, or other conventional approaches. Searches will be conducted in trial registries and databases including PubMed/MEDLINE, PubMed Central, AYUSH Research Portal, Ayushdhara, Shodhganga, and Google Scholar. Two independent reviewers will screen studies and extract data as per PRISMA guidelines, and risk of bias will be assessed using the Cochrane RoB 2 tool. Findings will be synthesized narratively (SWiM), and the certainty of evidence will be assessed using GRADE.

Conclusions This review will consolidate the existing evidence on Ayurvedic interventions for insomnia, identify critical research gaps, and provide a scientific foundation for future high-quality clinical trials and evidence-based Ayurvedic practice. Trial Registration: Trial registration isCRD420251180334 (PROSPERO).