1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


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 - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [anjali.shalakya@gmail.com].
   


6. For how long will this data be available start date provided 24-10-2025 and end date provided 24-10-2028?
   Response - Beginning 3 months and ending 5 years following article publication.
   


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

Shirah is the supreme part of the body and in Ayurveda classics, it is said to be of immense importance. Out of the total 107 marmas present in the body, 37 marmas are present in urdhvjatru parts. Therefore, all the shirorogas should be treated at the earliest and with care, because, if untreated, then, it may lead to grievous after-effects. Shirahshoola is the synonym as well as the symptom of all the Shirorogas described in Ayurveda.  A fit of violent headache without any apparent cause and which becomes worse in the night and is relieved by pressure or by being bandaged or by an application of fomentation around the head is known as the Vataja Shiroroga. Headache is one of the most common reasons patients seek medical attention as it causes disturbance and various degree of disability of an individual to deal with daily chores of life. A tension headache is generally a diffuse, mild to moderate pain that many people describe as feeling as if there’s a tight band around their head extending bilaterally back from the forehead across the sides of the head to the occipital and may extend to the posterior neck muscles.

Approximately 75% to 90% of all persons who complain of chronic or frequent headaches suffer from tension headache. Tension headache is more prevalent among women than men. About 69% of men and 88% of women develop a tension headache sometime during their lives. Tension headache can occur at any age but most commonly begins during adolescence or young adulthood, with the highest frequency among those aged 25-60 years. Tension type headache is most common in young adults with about 60% occurring in people over 20 years of age. Lifetime prevalence of episodic tension headache is between 30% and 78%. Global active prevalence of tension-type headache is 19.4%.

A Study was conducted in 2012 at NIA, Jaipur, which proved that Bala Taila Nasya and Gyan Mudra is very effective in the treatment of Vataja Shirahshoola. However, till date, no study has been conducted to evaluate the effect of Navsadar Taila Nasya in Vataja Shirahshoola.

Therefore, the current study has been planned to evaluate the efficacy of Navsadar Taila Nasya alongwith Gyan Mudra in Vataja Shirahshoola, and its comparative efficacy with Bala Taila Nasya alongwith Gyan Mudra. Also, Bala Taila is very costly, so, there is a need of an alternative Nasya drug which is cost-effective, and having the same or more efficacy as compared to Bala Taila. Navsadar Taila is easily available and comparatively cheaper, therefore, it is chosen as the trial drug for the current study.