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CTRI Number  CTRI/2023/07/055726 [Registered on: 26/07/2023] Trial Registered Prospectively
Last Modified On: 14/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [VIRECHANA KARMA]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Virechana Karma (Purgation) with Abhayaadi Modak and Vidangadi Yoga (Oral) in Psoriasis 
Scientific Title of Study   A Clinical Study To Evaluate The Efficancy Of Virechana Karma With Abhayaadi Modak & Vidangadi Yoga In EK-Kushtha With Special Referance To Psoriasis. 
Trial Acronym  VIVIABHYA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Rajesh Kumar 
Designation  M.D. Scholar (Panchakarma) 
Affiliation  Government P.G. Ayurveda College and Hospital,Varanasi 
Address  Department of Panchakarma ,Government P.G. Ayurveda College and Hospital,Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9451230273  
Fax    
Email  rajeshkumar1989rac@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Padma Lochana Sankhua 
Designation  Reader and H.O.D, Department of Panchakarma 
Affiliation  Government P.G. Ayurveda College and Hospital, Varanasi 
Address  Department of Panchakarma, ,Government P.G. Ayurveda College and Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  7376468851  
Fax    
Email  pls_bls@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Rajesh Kumar 
Designation  M.D Scholar (Panchakarma) 
Affiliation  Government P.G. Ayurveda College and Hospital,Varanasi 
Address  Department of Panchakarma ,Government P.G. Ayurveda College and Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9451230273  
Fax    
Email  rajeshkumar1989rac@gmail.com  
 
Source of Monetary or Material Support  
Government P.G. Ayurveda College and Hospital, Varanasi 
 
Primary Sponsor  
Name  Government PG Ayurveda College and Hospital Varanasi UP 
Address  DEPARTMENT OF PANCHAKARMA,GOVERNMENT P.G.AYURVEDA COLLEGE AND HOSPITAL,VARANASI 
Type of Sponsor  Government medical college 
 
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 
DR RAJESH KUMAR  Government P.G. Ayurveda College and Hospital, Varanasi  Department of Panchakarma, Government P.G. Ayurveda College and Hospital, Varanasi
Varanasi
UTTAR PRADESH 
9451230273

rajeshkumar1989rac@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,GOVERNMENT AYURVEDA COLLEGE AND HOSPITAL ,VARANASI,U.P,MAHAYOGI GURU GORAKHNATH AYUSH UNIVERSITY,GORAKHPUR,U.P  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Sharangdhara Samhita Uttar Tantra 4/27-34, Procedure details: Deepana Pachana with Panchakol Churna Followed by Snehapana with Panchatikta Ghrita with Abhayanga with Panchaguna Tail and Sarwang Swedana with Dashamoola Kwatha followed by Virechana with Abhayadi Modaka )
2Comparator ArmDrugClassical(1) Medicine Name: Vidangadi Yoga, Reference: Chakradutta Chikitsa 50/62, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 36 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -NAD
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age 20-60 years
2.Cardinal symptoms of Ekakustha
3.Positive sign of psoriasis like Auspitzsign(appearance of small bleeding points after successive layer of scalp have been removed),Candle grese sign (scratches patches of psoriasis with knife looks like greasy in nature)
4.Immunosuppressive drug ,corticosteroid as well as other modern medicine if any will be tapped gradually with a complete washout period of two week.
5.Chronicity of EkaKustha minimum 6 months to maximum 10 years. 
 
ExclusionCriteria 
Details  1. Patients having complication like severe renal diseases,retinopathy,severe hypertension,ischemic heart diseases, neuropathy, dyslipidemia, Uncontrolled diabeties etc.
2. Age less than 20 years and more than 60 years.
3. Patients associated with any immuno compromised diseases like AIDS,tuberculosis etc.
4. Patients having hypersensitivity to trial drug.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
moderate relief in symptoms of Psoriasis
 
21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in PASI SCORE Parameter  36 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/08/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In this part of study, literary review about disease EK-Kushtha will be collected from classical text of Ayurveda, thesis of previous research, scientific journals, periodical magazines, monographs & other available sources. Similarly modern review of the diseases will be collected from modern medicine books & various website on internet and these will be properly compiled, analysed , classified, and then will be presented in arrange manner.
Patients will be randomly selected from OPD and IPD of Department of Panchakarma, Government P.G. Ayurveda College and Hospital,Varanasi.

The present study will be carried out in two groups, each group consisting of 30 patients.

Group A:-- In this group each patient will be subjected for Virechana karma -

                   Purvakarma- Deepan pachan=Panchakol churna(3 days))
                                        Snehapan=Panchtikta Ghrita(as per patient )
                   Duration of procedure= 21 days
                    Follow Up -   on 21st day and on 36th day
                    Total Duration of trial=  36 days.

Group B:- In this group Vidangadi Yoga will be given as Shaman Yoga- 
.
                   Vidangadi Yoga 3gm twice a day with Madhu for 21 days.
                   Follow Up -   on 21st day and on 36th day
                   Total Duration of Trial:- 36 Days
 
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