1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  dr.a.laeeque@gmail.com


6. For how long will this data be available start date provided 25-01-2026 and end date provided 02-01-1970?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

Primary insomnia, known as Ibtidai Sahar in Unani medicine, is a common yet underrecognized disorder characterized by difficulty in initiating or maintaining sleep, early morning awakening, or non restorative sleep despite adequate opportunity to sleep. It results in significant daytime dysfunction and reduced quality of life. Modern medical systems recognize insomnia as an independent clinical disorder with defined diagnostic criteria in DSM five, ICSD three, and ICD ten. Chronic insomnia leads to fatigue, irritability, impaired concentration and memory, reduced productivity, and increases the risk of anxiety, depression, cardiovascular disease, diabetes, and immune dysfunction.

In Unani medicine, sleep or Nawm is considered essential for health and is one of the six fundamental factors known as Asbab i Sitta Zaruriyya. Sahar, also called Araq or Ifrat i Bedari, is attributed to derangement of temperament particularly hot and dry temperament of the brain, imbalance of humors, mental stress, pain, and dominance of Rooh i Nafsani. Classical scholars such as Ibn Sina described sleep as a natural cooling process that restores bodily functions. Unlike modern hypnotic drugs, which are associated with dependency and adverse effects, Unani medicine emphasizes regimenal and dietary therapies aimed at restoring balance safely and holistically.

Dalk i Layyin with Ravghan i Kahu is a well known Unani regimenal therapy used for its calming, sedative, and nervine strengthening effects. It helps relieve cerebral dryness, relax the nervous system, and promote natural sleep. Harira Maghz i Badam Wala is a classical Unani nutritive formulation that nourishes the brain and nerves and supports normal sleep through its sleep promoting and tonic properties.

The present study is a randomized parallel group interventional clinical trial designed to evaluate the efficacy and safety of Dalk i Layyin with Ravghan i Kahu, Harira Maghz i Badam Wala, and their combined therapy in patients with primary insomnia over a period of four weeks. Primary outcomes include improvement in sleep quality and insomnia severity, while secondary outcomes assess improvement in daytime symptoms and safety parameters. This study aims to generate scientific evidence for Unani interventions in the holistic management of primary insomnia.