Evaluation Of Efficacy And Safety Of Compound Unani Formulation Along With Roughan-E-Kishneez In The Management Of Sahr (Insomnia Disorder): A Single-Arm Clinical Trial

Insomnia a prevalent sleep disorder affecting 12-16% of the population globally with 33% prevalence among Indian adults, is defined as difficulty in initiating and maintaining sleep, is a growing public health concern affecting quality of life and risk of mental and physical health issues. Current treatments, though effective, provide temporary relief but often cause dependance. Unani medicine offers a holistic approach to insomnia, viewing it as “Sahr” caused by imbalance of humors, particularly the predominance of HARARAT and YABUSAT (heat and dryness) in the brain. Unani formulation with badranjboya (Melissa officinalis L.) & khuzama (Lavandula angustifolia Mill.) along with Roughan-e-kishneez are traditionally used to promote restful sleep. Given the historical textual evidence and emerging preclinical studies supporting their sedative, hypnotic and anxiolytic properties, there is a scientific rationale to systematically evaluate the efficacy and safety of Unani interventions in patients with insomnia. This study aims to bridge classical Unani knowledge with modern clinical research, providing evidence-based validation for these traditional therapies.