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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (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 )
| 2 | Comparator Arm | Drug | Classical | | (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 |