A Study Protocol for Randomized Waitlist-Controlled Trial on the Efficacy of Shirolepa in Adults with Primary Insomnia

Background and Objectives: Adults aged 18?60 years are recommended to have a sound sleep of 7 or more hours per night. Lack of sleep due to sleep disturbances, such as insomnia, causes significant impairment in an individual's quality of life. Insomnia shares many similarities with the condition mentioned in Ayurveda as nidranasha. The general Ayurvedic approach to insomnia includes a combination of therapies and internal medications. Ayurvedic therapies such as shirodhara (oil-dripping therapy), takradhara (buttermilk-dripping therapy), shirobasti (retention of oil on the head), and shirolepa (application of medicated paste over the head) are commonly used in the treatment of insomnia. However, no studies have been conducted to evaluate the role of shirolepa although it is widely practiced by Ayurvedic practitioners. Therefore, this study aims to evaluate the effect of shirolepa in adults with primary insomnia using subjective and objective parameters. Design: Two group pretest post-test design with randomization and waitlist control with 1:1 allocation ratio. Methods: The protocol adheres to Standard Protocol Items: Recommendations for Interventional Trials guidelines. Thirty-eight adults aged between 18 and 60 years with primary insomnia will be randomly assigned to intervention and waitlist control groups in 1:1 allocation ratio. The intervention group will receive shirolepa (application of medicinal herbal paste on the head) for 7 consecutive days. The control group will receive shirolepa after the post-test assessment. Our primary outcome is insomnia severity, which is evaluated using the Insomnia Severity Index. Secondary outcome measures will be evaluated using Pittsburgh Sleep Quality Index, Sleep Diary, Epworth Sleepiness Scale, and wrist actigraphy. Ethics and Dissemination: Ethical clearance was obtained from the Institutional Ethics Committee (01/PK/IEC/2021), and the trial was registered in the Clinical Trials Registry of India (CTRI/2022/09/045226). The study results will be reported and published in peer-reviewed journals.