An open label randomized comparative clinical study on the efficacy of Saraswatharishta and Drakshasava along with Pada Abhyanga in Anidra W.S.R to Primary Insomnia.

This study is a randomized open-label clinical trial evaluating the efficacy of two Ayurvedic formulations, Saraswatharishta and Drakshasava, in combination with Pada Abhyanga (foot massage with sesame oil), in managing Anidra (primary insomnia). Sleep being a critical aspect of health, its loss is considered a Vata-dominant disorder in Ayurveda. Anidra has been equated with primary insomnia, a widespread condition affecting up to 20% of the global population. Classical texts emphasize Nidra as one of the pillars of life. The study involves 40 patients aged 18–60 years, divided equally into two groups. One group receives Saraswatharishta and the other Drakshasava, both along with daily Pada Abhyanga for 30 days. Effectiveness is assessed using the Athens Insomnia Scale based on ICD-10 criteria. The hypothesis compares the relative effectiveness of both treatments. Drug formulations are prepared as per classical Ayurvedic procedures. The study aims to establish a safe, effective, and holistic Ayurvedic approach to treating insomnia, potentially contributing to standard clinical guidelines. Ethical approval has been obtained, and all parameters including adverse reactions, compliance, and follow-up are methodically planned.