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
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


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


6. For how long will this data be available start date provided 15-07-2023 and end date provided 17-03-2025?
   Response - Immediately following publication. No end date.
   


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

KusÌ£tÌ£ha is mentioned in Ayurvedic classics as an obstinate skin disorder which comes under the spectrum of Raktaja vikaÌ„ra’s (Ca.Su.24/16, Ca.Su.28/11). Among eleven types of KsÌ£udrakusÌ£tÌ£ha, KitÌ£ibhakusÌ£tÌ£ha is a condition in which there is vitiation of VaÌ„ta and Kapha dosÌ£a’s. Acharya VāghbaÅ£a mentioned KuÅŸÅ£ha as an indication of Virecana karma. Virecana is also considered as one of the important therapeutic options that has to be explored in the management of Rakta DusÌ£tÌ£i janya vikaÌ„ra’s (Ca.Su.24/18).

                   In modern parlance KitÌ£ibha can be co-related with Psoriasis. It is a genetically determined, auto immune kind of inflammatory skin disorder, the pathogenesis of which is still enigmatic in contemporary medicine. Cytokines play an important role in the pathophysiology of Psoriasis. Serum inflammatory markers are the important components of Cytokines and Interleukin -6 (IL-6) is one of the essential variety of Serum inflammatory markers, which could be found in high levels in lesional skin and in the peripheral blood of Psoriatic patients. High-sensitivity CRP (hs-CRP) is one among the inflammatory markers used to detect chronic inflammation and it measures low levels of CRP. An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. It’s an indirect marker of the inflammation levels in the body, because when inflammation is high, it takes longer for the red blood cells to drop. Systemic immune inflammation index (SII)  is also an inflammatory marker. The SII was calculated by the formula: neutrophil x platelet/lymphocyte, Neutrophil-lymphocyte ratio (NLR), monocyte-lymphocyte ratio (MLR) and platelet-lymphocyte ratio (PLR). A PASI score is a subjective tool used to measure the severity and extent of Psoriasis (Psoriasis Area and Severity Index), which will be helpful to assess the inflammatory status of psoriasis. 

Hence, in the present study it has been proposed that IL-6, hs CRP, ESR, SII (Systemic Immune Inflammation Index), in combination with PASI Score have been considered as inflammatory markers to assist in assessing disease severity and response to treatment in patients with psoriasis.

         In Caraka samÌ£hita Kalpa SthaÌ„na, KalyaÌ„nÌ£aka gudÌ£a is mentioned in SyaÌ„ma Trivruth Kalpa, which has been indicated in the management of KusÌ£tÌ£ha by inducing Virecana (C.Ka.7/40-45).

         Similarly, in AsÌ£tÌ£aÌ„ṅga HrÌ£daya CikitsaÌ„ sthaÌ„na, MaÌ„nÌ£ibhadra GudÌ£a is mentioned in KusÌ£tÌ£ha CikitsaÌ„ for inducing Virecana (A.H.Ch.19/31-32).

Thus, the present study is entitled as “A Clinico-Comparative study on the effect of Virecanakarma with Kalyāṇaka guḍa and Māṇibhadra guḍa on Inflammatory markers in Kiṭibhakuṣṭha (Psoriasis)”.