| CTRI Number |
CTRI/2018/10/016160 [Registered on: 25/10/2018] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of white patch |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines in Treatment of Vitiligo: Double-Blind, Randomized, Placebo-Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1221-7704 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Avaranjika |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Block–GE, Sector–III, Salt Lake, Kolkata–700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8778968586 |
| Fax |
|
| Email |
kannanavaranjika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swapan Paul |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, Room no - 12 & 13, Block–GE, Sector–III, Salt Lake, Kolkata–700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swapan Paul |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, Room no - 12 & 13, Block–GE, Sector–III, Salt Lake, Kolkata–700106
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block–GE, Sector–III, Salt Lake, Kolkata–700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block–GE, Sector–III, Salt Lake, Kolkata–700106 |
| 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 |
| K Avaranjika |
National Institute of Homoeopathy |
Department of Homoeopathic Materia Medica; Room no 12 & 13, Block - GE, Sector - III, Salt Lake, Kolkata - 700106
Kolkata
WEST BENGAL |
8778968586
kannanavaranjika@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicines in 50 millesimal potencies |
Intervention is planned as administering indicated homoeopathic medicines in fifty-millesimal potencies, as decided appropriate to the case or condition. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. Doses should be taken orally in empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of therapy: 6 months. |
| Comparator Agent |
Placebo |
This arm, will receive placebo, indistinguishable from verum. Each single non-medicated cane sugar globules of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup, to be taken orally in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Suffering from Vitiligo for at least last 3 months
2. Patients of both sexes
3. Age between 18-65 years
4. Literate; able to read English and/or Bengali
5. Patients who have not taken any treatment since last 2 weeks for Vitiligo |
|
| ExclusionCriteria |
| Details |
1. Patients who are too sick for consultation
2. Unwilling to take part and not giving consent to join the study
3. Unable to read patient information sheet
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure
5. Pregnancy and lactation
6. Substance abuse and/or dependence
7. Self-reported immune-compromised state
8. Undergoing homoeopathic treatment for any chronic disease within last 6 months. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vitiligo area scoring index (VASI) evaluateing disease extent and severity |
At baseline, 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitiligo Specific Health Related Quality of Life Instrument (VitiQOL) |
At baseline, 3rd month and 6th month |
| Dermatological Life Quality Index (DLQI) questionnaire |
At baseline, 3rd month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet, to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vitiligo is
an acquired de-pigmentation disorder
characterized by loss
of melanocytes from epidermis. Worldwide prevalence
of Vitiligo ranges
is 0.4 and 2% and in India the relative prevalence
varied between 0.46
and 8.8%. Studies reveals a
positive role of homoeopathy in Vitiligo
where varying degrees
of repigmentation was reported. In this prospective, double
blind, randomised, placebo controlled, parallel arm trial at National Institute
of Homoeopathy, 60 patients suffering from vitiligo will be randomised in 1:1
ratio into either individualised homeopathic medicines in 50 millesimal scale
or identical placebo. VASI will be used as the primary outcome measure and VitiQoL
questionnaire and DLQI as secondary outcome measures, measured at baseline, 3rd
month and 6th month. At the end of 6 months, comparative analysis
will be carried out to detect group differences, if any. Results will be
published in scientific journals. |