Randomized Controlled Trial evaluating Ayurvedic therapies- Siro pichu and Padabhyanga with Ksirabala Taila as an Add on to Cognitive Behavioural Therapy-Insomnia (CBT-I) for the management of Insomnia in Perimenopausal Women

The single centre parallel group randomized controlled trial is designed to evaluate the efficacy of Ayurvedic therapies Siro pichu and Padabhyanga with Ksirabala Taila as adjuncts to Cognitive Behavioural Therapy for Insomnia in the management of chronic insomnia among perimenopausal women aged 45 to 55 years. Insomnia affects nearly half of women during the menopausal transition and while CBT I is the recommended first line non pharmacological treatment it often requires 4 to 6 weeks for noticeable improvement leading to early discontinuation in up to 30 to 40 percent of patients. Ayurvedic therapies targeting Vata imbalance such as Siro pichu and Padabhyanga are traditionally used to induce relaxation and sleep with preclinical evidence suggesting effects on GABAergic modulation and parasympathetic activation. The trial will enroll eligible women with subthreshold to moderate insomnia after screening and informed consent. Participants will be randomized into two groups: the intervention group will receive CBT I along with Siro pichu for 30 minutes nightly for 7 days and Padabhyanga for twice daily for 14 days while the control group will receive CBT I alone. CBT I will be delivered to both groups through eight standardized sessions over four weeks, supplemented by sleep hygiene counselling. The primary outcomes are mean reduction in the Insomnia Severity Index and Pittsburgh Sleep Quality Index scores after four weeks. Secondary outcomes include early improvement in ISI scores at two weeks, sustained changes in ISI and PSQI during a three month follow up occurrence of adverse events and dependency risk assessed using the Severity of Dependency Scale, and adherence assessed by daily diaries. All Ayurvedic medicines will be sourced from a GMP certified manufacturer and administered under standard operating procedures. Safety will be closely monitored and rescue measures will be available if required. This academic trial, conducted at the Department of Prasuti Tantra and Stri Roga Amrita Ayurveda Hospital aims to generate evidence on whether integrating Ayurvedic therapies with CBT I can provide faster symptomatic relief enhance adherence and sustain sleep benefits without pharmacological risks in perimenopausal women with insomnia.