| CTRI Number |
CTRI/2025/02/080330 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Create and Test a Tool for Measuring the Severity of Vitiligo and Its Response to Treatment. |
|
Scientific Title of Study
|
An Analytical Study to Develop and Validate a Tool for Assessing the Severity of Shvitra and Evaluate Its Concordance Through Intervention. |
| 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 Anagha M S |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
3rd floor Academic block All India Institute of Ayurveda New Delhi India
South
DELHI
110076
India |
| Phone |
9539248164 |
| Fax |
|
| Email |
dr.anaghams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand More |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
3rd floor Academic block All India Institute of Ayurveda New Delhi.
South
DELHI
110076
India |
| Phone |
8830389544 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand More |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
3rd floor Academic block All India Institute of Ayurveda New Delhi.
South
DELHI
110076
India |
| Phone |
8830389544 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of roga nidana evum vikriti vigyan,3rd floor, academic block,All India Institute of Ayurveda,Gautampuri,sarita vihar, south Delhi pin 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda New Delhi |
| Address |
Gautampuri Awas Sarita Vihar New Delhi 110076 |
| Type of Sponsor |
Government medical college |
|
|
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 Anagha MS |
All India Institute of Ayurveda |
OPD Number 8,ground floor,hospital block,Gautampuri p.o. Saita Vihar South Delhi
South
DELHI |
9539248164
dr.anaghams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational Research and Biostatistics |
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: Sashilekha vati, Reference: Yogaratnakara Svitra Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -(2) Medicine Name: Bakuchi tailam, Reference: Rasaratna samuchayam, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Taila should be applied along with exposure to sunrays in morning during 7 to 8 am of effected parts during summer season and 8 to 9 am during winter season. Duration of oil application is from 5 to 45 minutes |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling 2024 ICD-10-CM Diagnosis Code L80 criteria.
Patient presenting with Saadya Lakshana of Shvitra (~Vitiligo)
Generalized and segmental stable vitiligo.
Patient who will give informed consent
|
|
| ExclusionCriteria |
| Details |
Active vitiligo defined by presence of confetti lesions trichrome lesion and Koebner phenomenon.
Pregnant women and breastfeeding or those who have recently delivered a baby within the past 6 months.
Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks.
Topical steroids within the prior 2 weeks.
Currently undergoing UVB light therapy or history of light therapy within the past 8 weeks. Enrolled in a clinical study of any other investigational drug or device.
Prescription medication or cosmetics containing: retinoids glycolic acid salicylic acid or any other remedies that might affect the healing process. Non-medicated moisturizers are allowed.
Self-reported history of chronic alcohol or drug abuse within 12 months prior to screening or any condition associated with poor compliance as judged by the investigation.
Subjects with active vitiligo treatment with other drug system for at least 3 months.
Lesions over the palms genital and burnt areas.
Subject having another systemic disease and other skin diseases.
Subjects with known allergies impaired cardiac hepatic and renal function.
History of malignancy.
Subjects suffering with Autoimmune disorders.
Any other condition or laboratory value that would in the professional opinion of the investigators potentially affect the subject response or the integrity of the data or would pose an unacceptable risk to the subject.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in severity of lesion or completion in study period whichever is earlier. |
0 day 1 month 2 month 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study evaluates changes in the Shvitra Severity Scale vitiligo extent using Wood’s lamp melanin content using Mexameter interferon-gamma levels using ELISA and CXCL10 gene expression using RT-PCR in participants treated with Shashilekha Vati internally and Bakuchi Taila externally over 90 days. Clinical validation of the tool will be achieved by correlating these parameters. |
0 day 1 month 2 month 3 month |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="2"
Days="30" |
|
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
|
This study aims to develop and validate the Shvitra Severity Scale to assess the severity of vitiligo in patients. The primary objective is to create a validated tool for classifying patients based on their condition’s severity, aiding treatment decisions. The secondary objective evaluates the efficacy of two Ayurvedic treatments Shashilekha Vati 250 mg twice a day internally and Bakuchi Taila externally for 90 days. Treatment outcomes will be assessed after 90 days using the developed Shvitra Severity Scale, Wood’s lamp Mexameter interferon-gamma levels CXCL10 gene expression and the VIS-22 quality of life questionnaire. This study fills a gap by introducing a validated severity scale improving patient classification treatment evaluation and supporting evidence based Ayurvedic practices for vitiligo. |