| CTRI Number |
CTRI/2022/03/041296 [Registered on: 23/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy for Vitiligo |
|
Scientific Title of Study
|
A clinical study for evaluating effectiveness of individualised homoeopathic medicine in the treatment of vitiligo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Singhal |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru homoeopathic medical College and hospital,B Block Defence Colony
B block defence colony
South
DELHI
110024
India |
| Phone |
8287684579 |
| Fax |
|
| Email |
nehasinghal1208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr George Mathew |
| Designation |
Reader (NFSG) |
| Affiliation |
Nehru homoeopathic medical College and hospital |
| Address |
Nehru homoeopathic medical College and hospital B block defence colony
B block defence colony
South
DELHI
110024
India |
| Phone |
9868396617 |
| Fax |
|
| Email |
drgeorgem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Singhal |
| Designation |
Junior resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
B Block Defence Colony
B Block Defence Colony
South
DELHI
110024
India |
| Phone |
8287684579 |
| Fax |
|
| Email |
nehasinghal1208@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru homoeopathic medical College and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Neha Singhal |
| Address |
Nehru homoeopathic medical College and hospital, B block defence colony New Delhi |
| Type of Sponsor |
Other [Junior resident] |
|
|
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 Neha Singhal |
Nehru homoeopathic medical College and hospital |
B block defence colony New Delhi
South
DELHI |
8287684579
nehasinghal1208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
| Intervention |
Individualised homoeopathic medicine |
Individualised homoeopathic medicine in centesimal potency on the basis of principles of homoeopathy as per the organon of medicine. All medicines will be procured from a Good Manufacturing Practice(GMP) certified firm. |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from vitiligo. |
|
| ExclusionCriteria |
| Details |
Cases with other auto-immune disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Size of skin lesion. |
Intially at the baseline then every month upto 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VASI score.
|
Initially at the baseline then every month upto 1 year. |
| VitiQol questionnaire. |
Initially at the baseline then every month upto 1 year. |
| Skindex-16 questionnaire. |
Initially at the baseline then every month upto 1 year. |
| DLQI questionnaire. |
Initially at the baseline then every month upto 1 year. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drnehasinghal12@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is an open label, prospective, uncontrolled clinical trial for evaluating the effectiveness of individualised homoeopathic medicine in the treatment of vitiligo. The homoeopathic medicine will be administered in centesimal scale, each dose shall consist of 6-8 globules of cane sugar, moistened with the indicated medicine to be taken orally on clean tongue; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP) certified firm. The outcomes will be assessed initially at the baseline and every month upto 1 year. |