| CTRI Number |
CTRI/2026/03/106571 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Virechana Karma along with drug and only drug in two group of 20 patients of Shvitra w.s.r to Vitiligo |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the effectiveness of Virechana Karma along with Shamana Aushadha and only Shamana Aushadha in the management of Shvitra w.s.r to Vitiligo |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUMAN |
| Designation |
MD( Ay.) Scholar, (Dept. of Panchkarma) |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Dept. of Panchakarma, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
09102240303 |
| Fax |
|
| Email |
drchoudharysuman3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SATYENDRA KUMAR TIWARI |
| Designation |
HOD and Prof. Dept. of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Dept. of Panchakarma, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
9024064735 |
| Fax |
|
| Email |
satyendratiwari.25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SATYENDRA KUMAR TIWARI |
| Designation |
HOD and Prof. Dept. of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Dept. of Panchakarma, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
9024064735 |
| Fax |
|
| Email |
satyendratiwari.25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, near Buddha Murti, Kadamkuan, Patna, Bihar-800003 |
|
|
Primary Sponsor
|
| Name |
Dr. Suman |
| Address |
Dept. of Panchkarma, Government Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan, Patna, Bihar-800003 |
| Type of Sponsor |
Other [self] |
|
|
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 SUMAN |
Government Ayurvedic College and Hospital |
Dept. of Panchakarma, OPD No. 11, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan
Patna
Patna
BIHAR |
09102240303
drchoudharysuman3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC) Govt. Ayurvedic College, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charak Samhita, Procedure details: Virechana Aushadha will be administered to patient through oral route one time )
(1) Medicine Name: Trivrit Avleha, Reference: Charak Samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 40(g), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aragvadhadyam Tailam, Reference: Chakardatt, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: After taila application sun exposure for 15 mints(2) Medicine Name: Bakuchi Churna, Reference: chakardatt, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Dhatri Khadir Kwath), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Shvitra like Arunata(vermilion coloured), Mandala(circular), Rukshata(dryness), pridhvanshi(when rubbed scales off morbid skin), for Vatika Shvitra, Padmapatra Pratikasam (eruptions resembling the petals
of a lotus flower), Sadaha (burning sensation), Romavidhvanshi (loss of hairs), Tamra
(coppery coloured) for Paitika shvitra and Kandu (itching), Shveta (white colored),
Bahala (thick) and Snigdha (glossy) for Shleshmika type of shvitra |
|
| ExclusionCriteria |
| Details |
Patients having chronicity more than 10 years
Patients having serious cardiac, renal, hepatic diseases, other conditions like insulindependent diabetes mellitus (IDDM), non-IDDM and any other serious systemic illness.
Gravid and lactating women.
Patients having patches due to burning or chemical explosion.
Patient having lesions at Guhyanga (genital organ), Panipadatala (sole of palm and feet),
Oshtha (lips), Aekanga (generalizedorgan), Sarvanga (generalized lesion) and patches
with Raktaroma (reddish hair) and Samsakta (coalescent).
Patients who comes under Virechana Ayogya condition as mentioned in classical texts of
Panchakarma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms of Shvitra (Vitiligo) i.e
.Color of Patches
.Margin of Patches
.Size of Patches
.Number of Patches
.Tvaka rukshata (Dryness of skin)
.Daha (Burning sensation)
.Kandu (Itching)
.Roma vaivarnyata (Discoloration of hair)
|
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VASI Score (Vitiligo area scoring index) |
60 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/04/2026 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized, open, parallel group, interventional prospective trial, comparing the effectiveness of virechana karma along with Shamana Aushadha in Group A and only Shamana Aushadha in Group B in the managment of Shvitra w.s.r to vitiligo, that will be conducted in Government Ayurvedic Medical College and Hospital at Patna, Bihar in the Department of Panchakarma. In each group, there will be 20 patients and study will be conducted for 60 days with follow up at every 15 days. |