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 - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


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) - 


6. For how long will this data be available start date provided 16-09-2024 and end date provided 31-05-2026?
   Response - Immediately following publication. No end date.
   


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

            VaÌ„tarakta is one of the unique disorder where both vaÌ„ta and rakta plays active role in the disease pathogenesis¹⁰. AÌ„charya Caraka mentions VaÌ„tarakta as raktaja vikaÌ„ra in VidhiÅ›onÌ£itiÌ„ya AdhyaÌ„ya in suÌ„tra sthaÌ„na (C.Su.24/12)⁷ and devoted an exclusive chapter to explain about the detailed aspects of VaÌ„tarakta in cikitsaÌ„ sthaÌ„na (C.Ci.29)⁸. In SuÅ›ruta SamÌ£hitaÌ„, VaÌ„tarakta is described in MahaÌ„vaÌ„tavyaÌ„dhi AdhyaÌ„ya of cikitsaÌ„ sthaÌ„na (Su.Ci.5/1-16)⁹.

          In VaÌ„tarakta, there is vitiation of vaÌ„ta and rakta where the excessively aggravated vaÌ„ta dosa is getting obstructed by aggravated rakta which further leads to the vitiation of raktadhaÌ„tu (C.Ci.29/10-11)¹⁰. 

           AÌ„charya Caraka mentioned two types of VaÌ„tarakta i.e. UttaÌ„na and GambhiÌ„ra. In UttaÌ„na VaÌ„tarakta, twak and mamsa dhatu are going to be involved, where as in GambhiÌ„ra VaÌ„tarakta the remaining deep seated dhatus are involved (C.Ci.29/19)¹¹.

          GambhiÌ„ra VaÌ„tarakta is a broader disease entity and avascular necrosis of the femoral head may be considered as one of its presenting form in modern perspective. That’s why in present study we are trying to compare GambhiÌ„ra VaÌ„tarakta with Avascular necrosis of the femoral head.

           Avascular Necrosis means necrosis of bone due to inadequate blood supply. It typically affects the epiphysis of long bones at weight-bearing joints. The most common sites for AVN are the femoral head, knee, talus, and humeral head. The most common cause is trauma and the non-traumatic causes includes excessive alcoholic intake as well as excessive consumption of systemic steroids¹². In the present study avascular necrosis of the femoral head is considered as this is the commonest presenting form. 

          The modern medical management of avascular necrosis of the femoral head depends on the severity of disease. Treatment outcomes correlate directly with the stages of disease. In early stages, management of avascular necrosis of the femoral head is done by bisphosphonates, non-steroidal anti-inflammatory drugs, extracorporeal shockwave therapy etc. In later stages management is done by surgical treatment that includes core decompression, femoral osteotomy, total hip arthroplasty etc¹². As these treatment modalities are having a lot of intricacies in terms of safety profile and cost effectiveness there is a dire need of exploring safe and effective alternate therapy. 

         In the present study, JaluÌ„kaÌ„vasecana and Vasti has been considered as the therapeutic interventions basing on the general line of treatment of VaÌ„tarakta (C.Ci.29/41)^13, (C.Ci.29/35-37)¹⁴.

           By considering all the above-mentioned aspects of VaÌ„tarakta, JaluÌ„kaÌ„vasecana is selected as one of the therapeutic module in the present study which is the most unique and effective method of blood-letting indicated in the management of vaÌ„tarakta, if there is pain, burning sensation, pricking pain along with reddish discoloration of skin (C.Ci.29/35-37)¹⁴.

         In the spectrum of vasti, for niruÌ„ha vasti purpose, YasÌ£tÌ£yaÌ„hvaÌ„di NiruÌ„ha vasti is selected which has been mentioned as the best one for the management of VaÌ„tarakta (C.Si.3/46)¹⁵.