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 - Anyone
   


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 - Proposals should be directed to [drveenagrao@yahoo.in].
   


6. For how long will this data be available start date provided 11-07-2024 and end date provided 11-06-2027?
   Response - Immediately following publication. No end date.
   


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

Osteoporosis is the second most common metabolic bone disease. Osteoporosis constitutes a major public health problem, on an average 25 million Indians are affected. Asthikshaya, which can be paralleled to osteopenia, further leads to Asthisaushirya i.e porous bones. 

Deterioration in the quantity & quality of bone mass are brought by an imbalance between bone resorption and bone formation processes that are normally coupled and is called as bone turnover. Markers of this bone turnover (BTM) have a variety of potential clinical applications based on their rapid response to treatment, their value in monitoring compliance to medications.

Establishing an Ayurvedic formulation which can arrest the pathology & effectively improve the bone mass without any adverse effects, is the need of the hour, as increase in the incidence of osteoporosis has gained the national priority for medical research in AYUSH.  

In order to develop evidence-based practice, a randomised open label, comparative, interventional clinical study is proposed.  Here the formulation ‘Gandha Taila’ will be given orally in the dosage of 1ml twice daily with warm water 30 minutes before food for a period of 120 days for 21 subjects of osteopenia or osteoporosis of both the groups A and B. Its efficacy will be assessed through 4 biochemical markers of bone formation & 5 markers of bone resorption in serum. As it validates the mode of action of both Gandha Taila,and Ksheerabala taila 101, this work will be highly useful for the clinical practise. As the trail also includes drug safety study among the subjects, which will further help in the overall improvement in patient care.

In this regard, it is a novel project in this field for evidence based medical practice as it will throw light on understanding the pharmacological action of drug ‘Gandha taila’ and Ksheerabala taila 101 over pathophysiology of osteoporosis which will be helpful in planning the treatment of osteoporosis.