| CTRI Number |
CTRI/2021/04/032978 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [VIRECHANA KARMA & UDARDA PRASHAMANA MAHAKASHAYA CHURNA] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
THERAPEUTIC PURGATION IN SKIN DISEASE |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIRECHANA KARMA AND UDARDA PRASHAMANA MAHAKASHAYA IN SHEETAPITTA W.S.R TO URTICARIA |
| Trial Acronym |
UDVISHEE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHUBHAM MAHESHWARI |
| Designation |
M.D SCHOLAR, PANCHAKARMA DEPARTMENT |
| Affiliation |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
| Address |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, CHAUKHAGHAT, VARANASI
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8279749968 |
| Fax |
|
| Email |
docshubham.mah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHUBHAM MAHESHWARI |
| Designation |
M.D SCHOLAR, PANCHAKARMA DEPARTMENT |
| Affiliation |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
| Address |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, CHAUKHAGHAT, VARANASI
UTTAR PRADESH
221002
India |
| Phone |
8279749968 |
| Fax |
|
| Email |
docshubham.mah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHUBHAM MAHESHWARI |
| Designation |
M.D SCHOLAR, PANCHAKARMA DEPARTMENT |
| Affiliation |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
| Address |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, CHAUKHAGHAT, VARANASI
UTTAR PRADESH
221002
India |
| Phone |
8279749968 |
| Fax |
|
| Email |
docshubham.mah@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 |
| Address |
Government P.G. Ayurveda College And Hospital, Chaukhaghat, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manish Mishra |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
DEPARTMENT OF KAYA CHIKITSA AND PANCHAKARMA, GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, CHAUKHAGHAT, VARANASI
Varanasi
UTTAR PRADESH |
9415896482
manish.arnav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government Post Graduate Ayurvedic College and Hospital Sampurnanand Sanskrit University Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L500||Allergic urticaria. Ayurveda Condition: Sheetapitta, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
UDARDA PRASHAMANA MAHAKASHAYA IN SHEETAPITTA |
5gm UDARDA PRASHAMANA MAHAKASHAYA CHURNA WITH LUKE WARM WATER TWICE A DAY |
| Comparator Agent |
VIRECHANA KARMA AND UDARDA PRASHAMANA MAHAKASHAYA IN SHEETAPITTA |
30-50ML ERANDA TAIL WITH DOUBLE AMOUNT TRIPHALA KWATH ALONG WITH 5gm UDARDA PRASHAMANA MAHAKASHAYA CHURNA WITH LUKE WARM WATER TWICE A DAY |
| Intervention |
VIRECHANA KARMA WITH ERANDA TAIL AND TRIPHALA KWATH IN SHEETAPITTA |
30-50ML ERANDA TAIL WITH DOUBLE AMOUNT TRIPHALA KWATH |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH CLASSICAL SYMPTOMS OF SHEETAPITTA viz. MANDALA UTSEDHA, TODA, DAHA, KANDU, CHHARDI.
VIRECHANA ARHA PATIENTS |
|
| ExclusionCriteria |
| Details |
HISTORY OF ANAPHYLAXIS TO MODERN MEDICINE PRESCRIBED FOR URTICARIA.
PATIENTS HAVING HISTORY OF ANY CHRONIC OR SYSTEMIC ILLNESS eg. HEART DISEASE, PARAPLASIA, TB, DIABETES, JAUNDICE, PREGNANT WOMEN, ANGIOEDEMA, LEPROSY, ECZEMA, FUNGAL INFECTION AND OTHER SKIN DISEASE. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RELIEF IN ITCHING AND RASHES |
10 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NO RELAPSE OF SYMPTOMS |
45 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2021 |
| Date of Study Completion (India) |
12/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Publication: World Journal of Pharmaceutical research
Title: URTICARIA: AN AYURVEDIC POINT OF VIEW
DOI: 10.20959/wjpr202111-21344 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This Study is a randomized, Multiple arm group study trial comparing the efficacy of Virechana Karma and Udarda Prashamana Mahakashya in Sheetapitta (Urticaria). Patients will be randomly selected from OPD and IPD of Department of Panchakarma, Government PG Ayurveda College and Hospital, Varanasi. 60 Patients will be studied under 3 groups having 20 patients in each group: Group 1: Virechana Karma by Eranda Tail with Triphala Kwath will be given approximate for 21 days. Group 2: Udarda Prashamana Mahakashya Churna (5 gm bid with luke warm water) will be given for 21 days. Group 3: Virechana Karma along with Udarda Prashamana Mahakashya Churna (5 gm bid with luke warm water) for 21 days. Follow up will be done after every 15 days of treatment in each group Statistical method of Analysis: The parameters of baseline data will be compared with the follow up status for assessment of results. |