| CTRI Number |
CTRI/2025/02/080651 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECTIVENESS OF VIRECHAN KARMA, POOTIKADI LEPA, KHADIR KASHAYAM IN THE MANAGEMENT IN SHWITRA (VITILIGO) - A CLINICAL STUDY |
|
Scientific Title of Study
|
EFFECTIVENESS OF VIRECHANA KARMA, POOTIKADI LEPA AND KHADIR KASHAYAM IN THE MANAGEMENT OF SHWITRA (VITILIGO) - A CLINICAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Pandey |
| Designation |
PG Scholar |
| Affiliation |
Pt Khushilal Sharma government autonomous ayurvedic college and institute bhopal |
| Address |
PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda college and institute, Science Hills, Nehru Nagar
BhopaL
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
07898278912 |
| Fax |
|
| Email |
pandeymanisha027@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kamini soni |
| Designation |
Associate professor |
| Affiliation |
Pt Khushilal Sharma government autonomous ayurvedic college and institute bhopal |
| Address |
PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda college and institute, Science Hills, Nehru Nagar
BhopaL
PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda college and institute, Science Hills, Nehru Nagar
BhopaL
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8770037353 |
| Fax |
|
| Email |
skamini382@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha Pandey |
| Designation |
PG Scholar |
| Affiliation |
Pt Khushilal Sharma government autonomous ayurvedic college and institute bhopal |
| Address |
PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda college and institute, Science Hills, Nehru Nagar
BhopaL
PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda college and institute, Science Hills, Nehru Nagar
BhopaL
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
07898278912 |
| Fax |
|
| Email |
pandeymanisha027@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda college and institute, Science Hills, Nehru Nagar
BhopaL |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Ayurveda college and institute, Science Hills, Nehru Nagar BhopaL |
| Address |
PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda college and institute, Science Hills, Nehru Nagar
BhopaL |
| Type of Sponsor |
Government funding agency |
|
|
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 Manisha Pandey |
Pt Khushilal Sharma Govt Ayurveda Collega and Institute Bhopal |
PG Department of panchakarma Pt Khushilal Sharma Govt Ayurveda Collega and Institute Bhopal
Bhopal
MADHYA PRADESH |
7898278912
pandeymanisha027@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Pt. Khushilal Sharma Government Ayurveda Institute, Bhopal (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L569||Acute skin change due to ultraviolet radiation, unspecified. Ayurveda Condition: SVITRAH, (2) ICD-10 Condition:L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue. Ayurveda Condition: SVITRAH, (3) ICD-10 Condition:L568||Other specified acute skin changesdue to ultraviolet radiation. Ayurveda Condition: SVITRAH, (4) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: charak samhita chikitsa chapter 7, Procedure details: virechan karma 7-11 days according to patient kosth)
(1) Medicine Name: khadira kashay, Reference: charak chikista chapter 7, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 1 Months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: pootikadi lepa, Reference: shushruta samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 100(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: khadir kashaym, Reference: charak chikitsa chapter 7, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having signs and symptoms of Shwitra (Vitiligo)
2 Patients of both the sex between 20 to 59 years of age
3 Patients fulfilling the diagnostic criteria of Shwitra
4 Willing to sign the written consent for participation in the study
5 Patients fit for Virechana Karma
|
|
| ExclusionCriteria |
| Details |
Patient with other chronic Systemic disease like serious Cardiac, Hepatic disease, Hypertension, Diabetes Mellites, Ischemic heart disease, Anemia, Tuberculosis, Malignancy, etc. will be excluded.
Pregnant and Lactating women will not be included in the study.
Patients contraindicated for Virechana Karma as per Ayurvedic classics. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study, we will be able to demonstrate the effectiveness of Virechana karma, Pootikadi Lepa, and Khadir Kashayam in the management of Shwitra(vitiligo) - A Clinical Study |
12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study, we will be able to demonstrate the effectiveness of Virechana karma, Pootikadi Lepa, and Khadir Kashayam in the management of Shwitra(vitiligo) - A Clinical Study |
11 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="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
|
From this study, it is expected that at the end of the study we would be able to demonstrate the effectiveness of virechan karma, pootikadi lepa, and khadir kashayam in the management of shwitra(vitiligo). it is further expected that this study would be able to provide conclusive inputs to assess the efficacy of the ayurvedic management of shwitra. |