| CTRI Number |
CTRI/2026/01/101955 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of Virechana Karma (a Panchakarma detoxification therapy), along with oral Kakoudumbarikadi Kashaya (50 ml twice daily) and external application of Avalgujabijadi Lepa, in the treatment of Shwitra (Vitiligo) |
|
Scientific Title of Study
|
A Controlled clinical study to evaluate efficacy of Virechana karma followed by Kakoudumbarikadi Kashaya along with Avalgujabijadi lepa in Shwitra (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 Shilpa D |
| Designation |
Post Graduate Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Dept of kayachikitsa OPD No-1,2,3,4,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,SH 17 Anchepalya,Kumbalagodu post,Bangalore-560074,Karnataka,India
Bangalore
KARNATAKA
560074
India |
| Phone |
7204421998 |
| Fax |
|
| Email |
shilpadeveraj1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Sharma M |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Dept of kayachikitsa OPD No-1 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,SH 17 Anchepalya,Kumbalagodu post,Bangalore-560074,Karnataka,India
Bangalore
KARNATAKA
560074
India |
| Phone |
9964022654 |
| Fax |
|
| Email |
drsharmamysr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Sharma M |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Dept of kayachikitsa OPD No-1 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,SH 17 Anchepalya,Kumbalagodu post,Bangalore-560074,Karnataka,India
Bangalore
KARNATAKA
560074
India |
| Phone |
9964022654 |
| Fax |
|
| Email |
drsharmamysr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shilpa D |
| Address |
Dept of kayachikitsa OPD No-1,2,3,4,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,SH 17 Anchepalya,Kumbalagodu post,Bangalore-560074,Karnataka,India |
| 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 Shilpa D |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
Dept of kayachikitsa OPD No-1,2,3,4,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,SH 17 Anchepalya,Kumbalagodu post,Bangalore-560074,Karnataka,India
Bangalore
KARNATAKA |
7204421998
shilpadeveraj1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Ayurveda and Hospital |
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 | Drug | Classical | | (1) Medicine Name: Kakoudumbarikadi Kashaya, Reference: Sahasra Yoga Kashaya Kalpana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ushnajalapana ), Additional Information: Along with Avalgujabijadi lepa as an external application | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadiradi Kashaya, Reference: Yoga Ratnakara Kushta Chikitsa , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ushnajalapana), Additional Information: Along with Avalgujabijadi lepa as an external application |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects exhibiting the Sadhya Lakshanas of Shwitra i.e.
Shwetha Mandala (white patch)
Aparisravi (non-exudate)
Ashukla Roma (no whitish discolouration of hairs)
Anagnidagdha (patches which are not caused due to burn), will be selected
Participants of irrespective gender, religion, occupation and socio-economic status within the age group
of 18 to 60 years.
Chronicity of the disease should be less than 10 years.
Subjects assessed and fit for Virechana (therapeutic purgation) |
|
| ExclusionCriteria |
| Details |
Patients with Systemic disorders like uncontrolled Diabetes mellitus, Hypertension, Hyper and
Hypothyroidism that interfering with the course of treatment
Patients unfit for Virechana karma
Patients having chronicity more than 10 years
Lesions over lip and genital areas
Congenital pigmental disorders
Other pigmented skin disorders
Secondary depigmentation disorders caused due to burns & wounds. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement noticed in reduction in signs and symptoms based on Vitiligo area severity index
(VASI) and Vitiligo Disease Activity Score (VIDA). |
Before treatment
After Virechana Krama
After 15 days of Shamanayoga
Follow up after 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant improvement noticed in the Quality of life (Vitiligo impact scale-22) of patient and reduction
in signs and symptoms of Shwitra. |
Before treatment
After Virechana Krama
After 15 days of Shamanayoga
Follow up after 45th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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="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
|
A Controlled Clinical Study To Evaluate The Efficacy Of Virechana Karma followed By Kakoudumabarikadi kashaya Along With Avalgujabijadi Lepa In Shwitra (Vitiligo) in adults of age group 18-60 years for a period of 30 days. During this study period 30 subjects diagnosed with SHWITRA (VITILIGO) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group) 15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Virechana as Shodhana karma followed by Kakoudumbarikadi Kashaya as Shamana Yoga along with Avalgujabijadi Lepa as an external application for 15 days starting from day-01 of trial, assessment of the patient during trial Before treatment, After Virechana Krama, After 15 days of Shamanayoga, Follow up after 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Virechana as Shodhana karma followed by Khadiradi Kashaya as Shamana Yoga along with Avalgujabijadi Lepa as an external application for 15 days starting from day-01 of trial, assessment of the patient during trial Before treatment, After Virechana Krama, After 15 days of Shamanayoga, Follow up after 45th day. The primary outcome measure will be Significant improvement noticed in reduction in signs and symptoms based on Vitiligo area severity index (VASI) and Vitiligo Disease Activity Score (VIDA) after 30 days. The secondary outcome measure will be Significant improvement noticed in the Quality of life (Vitiligo impact scale-22) of patient and reduction in signs and symptoms of Shwitra. after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment. |