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CTRI Number  CTRI/2021/05/033901 [Registered on: 31/05/2021] Trial Registered Prospectively
Last Modified On: 26/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical study to know the effect of powder massage and pouring of medicated buttermilk followed by therapeutic Emesis in treating Psoriasis 
Scientific Title of Study   An open label single arm study to evaluate the efficacy of Sarvanga Udvartana and Sarvanga Takradhara followed by Vamana Karma in the management of Eka-Kusta Vis-A-Vis Psoriasis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NOT APPLICABLE  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siramsetty Jagadesh Kumar 
Designation  Post graduate Scholar 
Affiliation  Sri Kalabyraveshwara swamy ayurvedic medical college hospital and research center 
Address  Department of PG Studies in Panchakarma Sri Kalabyraveshwara swamy ayurvedic medical college Hospital and research Center Vijayanagara Bengaluru
Vijayanagara Bengaluru
Bangalore
KARNATAKA
560104
India 
Phone  8884712614  
Fax    
Email  jagadeshrocky@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kiran M Goud 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara swamy ayurvedic medical college hospital and research center 
Address  Department of PG Studies in Panchakarma Sri Kalabyraveshwara swamy Ayurvedic Medical College Hospital and Research center

Bangalore
KARNATAKA
560104
India 
Phone  9845109556  
Fax    
Email  kiranmgoud@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kiran M Goud 
Designation  Professor 
Affiliation  SKAMCH RC 
Address  Principal Sri Kalabyraveshwara ayurvedic medical college Hospital and Research center Vijayanagar Bengaluru

Bangalore
KARNATAKA
560104
India 
Phone  9845109556  
Fax    
Email  kiranmgoud@yahoo.co.in  
 
Source of Monetary or Material Support  
Self Sponsored Dr Siramsetty Jagadesh Kumar PG Scholar Department of PG Studies in Panchakarma Sri Kalabyraveshwara swamy ayurvedic medical college hospital and Research center Vijayanagar Bengaluru 
 
Primary Sponsor  
Name  Dr Siramsetty Jagadesh Kumar 
Address  PG Scholar Department of PG Studies in Panchakarma Sri Kalabyraveshwara swamy ayurvedic medical college hospital and research center Vijayanagar Bengaluru  
Type of Sponsor  Other [Self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NOT APPLICABLE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran M Goud  Sri Kalabyraveshwara swamy ayurvedic medical college hospital and research center  Department of PG Studies in Panchakarma No 10 Pipeline road R P C Layout Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA 		 9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMCH RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Only Panchakarma  Intially Sarvanga Udvartana and Sarvanga Takradhara was done for 14 days followed by Snehapana with Mahatiktaka Ghruta given for minimum of 3 to 7 days based samyak snigdha lakshanas later subjects were posted for Vishrama kala for 1 day and Vamana was done with Madanaphala pippali yoga in Kashaya form about 150 ml  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subject presenting with lakshanas of EkaKushta
Subject presenting with signs & symptoms of Psoriasis
Subject fit for Udvartana
Subject fit for Takradhara
Subject fit for Snehapana
Subject fit for Vamana karma
 
 
ExclusionCriteria 
Details  Psoriasis associated with Major systemic disorders that interfere with the course of treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Sarvanga Udvartana and Sarvanga Takradhara followed by Vamana Karma showed efficient results in the management of Psoriasis
It was assessed BT before Sarvanga Udvartana and Sarvanga Takradhara AT1 After Sarvanga Udvartana and Sarvanga Takradhara AT2 After vamana karma based on subjective parameters - Aswedanam mahavastu Mastyashakalopamam Dryness Erythema Itching sensation and Objective prameter PASI Scoring all the parameters showed statistically highly significant 		 19 to 23 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="21" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The present study entitled " â€œAN OPEN – LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY OF SARVANGA UDVARTANA & SARVANGA TAKRADHARA FOLLOWED BY VAMANA KARMA IN THE MANAGEMENT OF EKAKUSTA VIS-A-VIS PSORIASIS”.
The effect of treating in all parameters like Matsyashakalopamam(Scaling), Aswedanam (Anhydrosis), Mahavastu (Extent of lesion), Dryness, Burning sensation, Itching, Erythema, PSAI has shown statistically highly significant results.
 
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