| CTRI Number |
CTRI/2025/07/091687 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Homoeopathic treatment in Vitiligo for change in area, stage and spread of depigmented patch after treatment for 1 year |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic medicine (IH) and Arsenic
Sulphuratum Flavum (ASF) in LM Potency in Vitiligo-A Single blind,
Randomized, Comparative, Parallel group 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 |
Dr Renu Bala |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Research Institute (Homoeopathy) under Central Council for Research in Homoeopathy |
| Address |
Room No 210
Clinical Research Department
Central Research Institute (Homoeopathy),Sector -2, Janakipuram extension,
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09140570079 |
| Fax |
|
| Email |
drrenu3011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Bala |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Research Institute (Homoeopathy) under Central Council for Research in Homoeopathy |
| Address |
Room No 210
Clinical Research Department
Central Research Institute (Homoeopathy),Sector -2, Janakipuram extension,
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09140570079 |
| Fax |
|
| Email |
drrenu3011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 309
Department of Clinical Research
Central Council for Research in Homoeopathy
61-65, Institutional area, Opposite D block, Janakpuri, New Delhi
New Delhi
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area, Opposite D block, Janakpuri, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 Renu Bala |
Central Research Institute (Homoeopathy) |
Room No 210
Department of Clinical Research
Central Research Institute (Homoeopathy),Sector -2, Janakipuram extension,Lucknow
Lucknow
UTTAR PRADESH |
09140570079
drrenu3011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arsenic Sulphuratum Flavum for 12 months |
Specific homoeopathic medicine |
| Intervention |
Individualized Homoeopathic medicine for 12 months |
Homoeopathic medicine after repertorization of totality of symptoms |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Vitiligo lesion (1 or more) on any part of the body.
2. At least one patch to be more than 3cm in length and 3cm in width.
3. Patients of 18 year or more age group and both sex.
4. Patient giving written consent for study and photographic evidence |
|
| ExclusionCriteria |
| Details |
• Patients on any other (allopathic/ ayurvedic/ naturopathic) treatment either topical or
systemic for Vitiligo.
• Patient on laser or Phototherapy treatment for Vitiligo lesion.
• Patient on treatment with immune-modulating oral medications for other NCD or
systemic illnesses.
• Patient suffering with other skin conditions (like dermatophytosis, scabies, ringworm,
eczema etc.)
• Patients with hypothyroidism, or vitamin B 12 deficiency(below 200 pg/mL).
• Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Vitiligo European Task Force (VETF) scale |
At baseline and every month till 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in
1) Vitiligo Quality of life (VitiQoL)
2) Stigma Scale for Chronic Illnesses 8-item version (SSCI-8)
3) Laboratory parameters of Anti tyrosinase antibodies and Alpha Melanocyte Stimulating
Hormone. |
VitiQoL, SSCI-8 at baseline,one month interval till 12 months
Laboratory parameters at baseline, 6 month and 12 month |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="3"
Months="0"
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
|
The present study has been designed to compare the response to individualized homoeopathic treatment in LM scale and ASF in LM scale in vitiligo, using standardized parameters for assessment. The study will be conducted in compliance with this protocol, according to Declaration of Helsinki and Good Clinical Practice in India. Null hypothesis (H0) There is no significant difference between IH and ASF with respect to change in area, stage and spread of depigmented patchesin patients of Vitiligo measured on identified parameters. Alternative Hypothesis (Ha) There is a significant difference between IH and ASF with respect to change in area, stage and spread of depigmented patches in patients of Vitiligo measured on identified parameters |