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CTRI Number  CTRI/2013/07/003852 [Registered on: 30/07/2013] Trial Registered Retrospectively
Last Modified On: 06/10/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive
Other (Specify) [Virechana and Parisheka ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Application of Ayurvedic treatment in Psoriasis A type of skin disease 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SIDHARTAKA AND PANCHVALKALA PARISHEKA AFTER VIRECHANA IN EKAKUSHTHA (PSORIASIS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANUP B THAKAR 
Designation  Associate Professor and Head 
Affiliation  Institute for Post graduate teaching and research in Ayurveda 
Address  Associate Professor and Head Department of Panchakarma Institute for Post graduate teaching and research in Ayurveda Guajarat Ayurved University Jamnagar
Associate Professor and Head Department of Panchakarma Institute for Post graduate teaching and research in Ayurveda Guajarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Prasanth Dharmarajan 
Designation  Ph D Scholar 
Affiliation  Gujarat Ayurved University 
Address  Ph D Scholar Dept of Panchakarma Institute for Post graduate teaching and research in Ayurveda Guajarat Ayurved University Jamnagar
Ph D Scholar Department of Panchakarma Institute for Post graduate teaching and research in Ayurveda Guajarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  8347335685  
Fax    
Email  drprasanthd@gmail.com  
 
Details of Contact Person
Public Query  
Name  ANUP B THAKAR 
Designation  Associate Professor and Head 
Affiliation  Institute for Post graduate teaching and research in Ayurveda 
Address  Associate Professor and Head Department of Panchakarma Institute for Post graduate teaching and research in Ayurveda Guajarat Ayurved University Jamnagar
Associate Professor and Head Department of Panchakarma Institute for Post graduate teaching and research in Ayurveda Guajarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Post graduate teaching Hospital Institute for Post Graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar 
 
Primary Sponsor  
Name  Institute for Post graduate teaching and research in Ayurveda 
Address  Post graduate teaching Hospital Gujarat Ayurved University Jamnagar 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anup B Thakar  post graduate teaching hospital   institute for post graduate teaching and research in ayurveda gujarat ayurved university jamnagar
Jamnagar
GUJARAT 		 9427776660

anup_thakar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PSORIASIS ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Panchavalkala Kwatha Parisheka  Panchavalkala Kwatha Parisheka GpB Deepana and Pachana with Trikatu Choorna 2gm bd for 2 days Snehapana with plane go ghrita till samyak snigdha lakshanas Abhyanga and Ooshmasweda for 3 days Virechana with Trivrut danti kashaya 1day Dose 90 ml Samsarjana karma according to Shuddhi Panchavalkala parisheka for 7 days Shaman siddhartaka kashaya Dose 30ml 20gms bd for 30 days  
Comparator Agent  Shaman siddhartaka kashaya   Deepana and Pachana with Trikatu Choorna 2gm bd for 2 days Snehapana with plane goghrita till samyak snigdha lakshanas Abhyanga and Ooshmasweda for 3 days Virechana with Trivrut danti kashaya 1day Dose 90ml Samsarjana karma according to Shuddhi Shaman siddhartaka kashaya Dose 30ml 20 gms bd for 30 days  
Intervention  Sidharthaka Kwathaparisheka  Sidharthaka Kwathaparisheka GpA Deepana and Pachana with Trikatu Choorna 2gm bd for 2 days Snehapana with plane go ghrita till samyak snigdha lakshanas Abhyanga and Ooshmasweda for 3 days Virechana with Trivrut danti kashaya 1day Dose 90 ml Samsarjana karma according to Shuddhi Siddhartaka parisheka for 7 days Shaman siddhartaka kashaya Dose 30ml 20gms bd for 30 days  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients with all forms of Ekakushtha (Psoriasis)
2 Who are clinically fit to undergo Virechana and parisheka karma
3 Patients aged 12 years to 60 years 
 
ExclusionCriteria 
Details  Patients who are clinically unfit for Virechana and parisheka Karma.
1 Age less than 13yrs and more than 60yrs
2 Pregnant women
3 Any other serious systemic illness
4 Patients who are not willing for admission (treatment)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Marked improvement in itching and scaling and other clinical features
2 complete remission of psoriatic lesions
3 Non recurrence after the follow up period 		 20th day
50th day
80th day 
 
Secondary Outcome  
Outcome  TimePoints 
1 Improvement in skin texture
2 Improvement in Dermatological QOL 		 20th day
50th day
80th day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   27/04/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Various studies had been conducted about the efficacy of Virechana on Ekakushtha (Psoriasis) in various centres and it is proven to be effective. So in this study an attempt will be made to study the action of particular Virechana yoga in psoriasis and the comparative efficacy of two different Parishekas along with Shaman, following the Sodhana in the management of Ekakushtha (Psoriasis). Thus a humble effort is made to frame a comprehensive treatment modality for the management of psoriasis. 

 
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