| CTRI Number |
CTRI/2025/08/093367 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of Shwitra by Dhatri Khadiradi kashaya and Avalgujadi lep |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF DHATRI KHADIRADI KASHAYAM AND AVALGUJADI LEPA IN THE MANAGEMENT OF SHWITRA VITILIGO |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Badadwal |
| Designation |
MD Scholar |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7984553815 |
| Fax |
|
| Email |
poojabadadwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lajwanti Keswani |
| Designation |
Professor |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
940656409 |
| Fax |
|
| Email |
123laj321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Badadwal |
| Designation |
MD Scholar |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7984553815 |
| Fax |
|
| Email |
poojabadadwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Khushilal Sharma Government Ayurveda College Behind Manit Science Hills and Institute Bhopal India 462003 |
|
|
Primary Sponsor
|
| Name |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
| Address |
Science Hills Behind Manit Kolar Road Bhopal MP India 462003 |
| 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 Pooja Badadwal |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
PG Department Of samhita Siddhant Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal
Bhopal
MADHYA PRADESH |
07984553815
poojabadadwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Pt Khushilal Sharma Govt Ayurveda College And Institute Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: VITIL, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatri khadiradi kashayam, Reference: Chakradatta samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: group 2 is placebo group | | 2 | Comparator Arm (Non Ayurveda) | | - | Semolina powder capsule | capsule filled with semolina powder route oral dose 500mg for 30 days frequency bid |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
Patients age group between 18-55years
Patients having Shwitra patch with normal sensation in touch
Patients who are willing to participate in the study
Duration of the disease being 1-2 years |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
Patients suffering from other systemic disorders like renal failure hepatic disorders cancer HIV and endocrine system related disorders with prolonged medication history
Shwitra due to Agnidagdha or other injuries Vranaja shwitra
White patches on lips and genital organs
Congenital Shwitra and other depigmentory disorders
Shwitra caused by other autoimmune conditions
Pregnant and lactating women
Exanthematous rashes or any other inflammatory skin disease |
|
|
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 should be able to evaluate the outcome of Dhatrikhadiradi Kashayam and Avalgujadi lep in the management of Shwitra within thirty days of the trial |
it is expected that within four weeks of the trial there will be significant result of the trial |
|
|
Secondary Outcome
|
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="6"
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
|
Various skin problems affect approximately 20-30% of the world population and worldwide prevalence of Shwitra is observed as 1-2%. Th The highest incidence has been recorded in India, based on dermatologic outpatient’s record. India is considered to have the highest prevalence in the world, at about 8.8% has also been reported irrespective of races especially to dark skinned colour.Shwitra is associated with significant quality -of-life impairment in routine activities, employment and many psychological as well as social problems for patients.Sometimes people with this condition may face discrimination, misconceptions about their appearance. Some individuals may experience feelings of embarrassment, isolation, low self-esteem due to societal attitudes towards their skin condition. Ayurveda has reached zenith of knowledge in samhita kala regarding the application of Lepa for therapeutic and cosmetic purpose. Therefore, there is a need for study to re-establish the concept of Lepana Karma and Aushadha Yoga already described in the Samhita. Drugs mentioned in Dhatrikhadiradi Kashayam are mainly Tridoshamak, Raktaprasadak in nature,soit can be used internally and katu tikta rasa, ruksha guna, katu vipak of the Bakuchi and ushna guna of Gomutra increase blood circulation locally or help in adequate formation of Prakrut Bhrajak Pitta in the skin. These two formulations that may be effectively treat Shwitra along with increasing the quality of life. |