A randomised controlled clinical trial between clonazepam, ayurvedic polyherbal formulation, and shirodhara in the management of anidra (insomnia)

A RANDOMISED CONTROLLED CLINICAL TRIAL BETWEEN CLONAZEPAM, AYURVEDIC POLYHERBAL FORMULATION AND SHIRODHARA IN THE MANAGEMENT OF ANIDRA (INSOMNIA).

Anidra (Insomnia) is a prevalent sleep disorder that significantly impairs physical health, mental well-being, and quality of life. Anidra (Insomnia) is described in Ayurveda as a disorder resulting from the vitiation of Vata and Pitta doshas, leading to impaired Nidra—one of the Trayopastambha essential for sustaining life. In contemporary practice, insomnia is commonly managed with benzodiazepines such as clonazepam; however, their long-term use is limited by adverse effects, including dependence, tolerance, and cognitive impairment. Ayurveda offers holistic, non-habit-forming therapeutic modalities through Medhya and Nidrajanana herbs, along with Panchakarma procedures such as Shirodhara. The present study is designed as a randomised, controlled, open-label, three-arm clinical trial to evaluate and compare the efficacy and safety of clonazepam, an Ayurvedic polyherbal formulation, and the combination of the same formulation with Shirodhara in the management of Anidra. Ninety diagnosed patients fulfilling the inclusion criteria will be randomly allocated into three groups (n=30 each). Group A will receive clonazepam (0.5 mg) at bedtime; Group B will receive an Ayurvedic polyherbal formulation containing Tagara (Valeriana wallichii), Jatamansi (Nardostachys jatamansi), and Shankhapushpi (Convolvulus pluricaulis)at bedtime; and Group C will receive the same formulation along with Shirodhara using Kshira for 21 days. Clinical assessment will be carried out using validated subjective parameters, namely the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI), along with sleep latency and sleep duration. Data will be analysed using a paired t-test for within-group comparison and one-way Analysis of Variance (ANOVA) followed by post-hoc tests for intergroup comparison. A p-value <0.05 will be considered statistically significant. The study is expected to establish Ayurvedic interventions, particularly polyherbal formulation with Shirodhara, as effective, safe, and sustainable alternatives to conventional pharmacotherapy for Anidra.