| CTRI Number |
CTRI/2018/04/013446 [Registered on: 24/04/2018] Trial Registered Prospectively |
| Last Modified On: |
13/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Homeopathic treatment of white patches on skin |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines and Psoralea corylifolia mother tincture external application in vitiligo: an open randomized pragmatic trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abijit Chattopadhyay |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7003547446 |
| Fax |
|
| Email |
drac.nih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anaitullah Ahmad Mir |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7006951253 |
| Fax |
|
| Email |
civildefence12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anaitullah Ahmad Mir |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
7006951253 |
| Fax |
|
| Email |
civildefence12@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
| Type of Sponsor |
Private 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 |
| Abhijit Chattopadhyay |
National Institute of Homoeopathy, Govt. of India |
OPD room no. 12 and
13, Dept. of Homoeopathic Materia Medica; Block GE,
Sector III, Salt Lake,
Kolkata 700106
Kolkata
WEST BENGAL |
7003547446
drac.nih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of National Institute of Homoeopathy |
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 |
Indicated homeopathic
medicines in centesimal or fifty
millesimal potencies |
Indicated homeopathic
medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v
ethanol) in 5 ml of distilled
water; dosage and repetition
depending upon the individual
requirement of the cases. 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. Medicines are to be taken orally on clean tongue with empty stomach. Duration of therapy: 6
months |
| Comparator Agent |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies plus Psoralea corylifolia mother tincture external application |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v ethanol) in 5 ml of distilled water; dosage and repetition depending upon the individual requirement of the cases. 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. Medicines are to be taken orally on clean tongue with empty stomach. Along with this, Psoralea corylifolia mother tincture external application; to apply locally by moistening cotton with the medicine, followed by exposure to sunlight for minimum 15 minutes. If local irritation becomes troublesome, the medicine will be diluted in 1:10 ratio in normal cold water. If local irritation still persists, it will be further diluted in 1:20 ratio and will be continued; otherwise the patient will be discontinued from the study. Duration of therapy: 6 months |
| Comparator Agent |
Psoralea corylifolia mother tincture external application |
Psoralea corylifolia mother tincture external application; to apply locally by moistening cotton with the medicine, followed by exposure to sunlight for minimum 15 minutes. If local irritation becomes troublesome, the medicine will be diluted in 1:10 ratio in normal cold water. If local irritation still persists, it will be further diluted in 1:20 ratio and will be continued; otherwise the patient will be discontinued from the study. Duration of therapy: 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65 years
2. Both sexes
3. Literate; able to read English or Bengali
4. Suffering from vitiligo for at least last 3 months |
|
| ExclusionCriteria |
| Details |
1. Patients who are too sick for consultation
2. Patients not giving consent to take part
3. Diagnosed cases of unstable psychiatric illness or other systemic disease or infection affecting quality of life or any vital organ failure
4. Pregnancy and lactation
5. Self-reported immune-compromised state
6. Substance abuse and/or dependence
7. Undergoing homeopathic treatment for any chronic disease within last 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vitiligo Area Scoring Index (VASI) |
Baseline, after 3 months and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitiligo Quality of Life Questionnaire (VitiQoL) |
Baseline, after 3 months and after 6 months |
| Dermatological Life Quality Index (DLQI) questionnaire |
Baseline, after 3 months and after 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/04/2018 |
| Date of Study Completion (India) |
27/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None 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 a common chronic skin depigmentation
disorder. It is due to stoppage of melanin formation by the melanocytes and presents
as asymptomatic depigmented macules anywhere on the body including mucous
membranes of lips and genitalia. In vitiligo, there is a marked reduction or even
absence of melanocytes and melanin in the epidermis. It affects around 0.5%-1% of the world population. As high as 8.8% prevalence have been reported in
India, where considerable stigma is attached to the disease. Vitiligo patches can appear anywhere on the
skin, but commonly affected sites include the area around the orifices, the
genitals or any sun-exposed areas such as the face and hands. The hair and
rarely, the eyes may also be affected. Fifty percent of cases appear before the age of
20, with the disfigurement resulting in psychiatric morbidity in 16-35% of
those affected. Depression, sleep disturbances, suicidal thoughts, suicidal attempts,
difficulties in relationships, and avoidance of social situations have been
reported in individuals afflicted by vitiligo before adulthood. In India, in particular, it ranges from 6.25-18%.
Some studies reveal it as high as 40%. In 19th century, practitioners acknowledged limitations for
treatment of this condition and suggested Sulphide of Arsenicum to lessen the
patch. The homoeopathic literature suggest a number of medicines for the conditions. In a recent review, 11 research papers related to homoeopathy on vitiligo
were identified. The investigators also identified a recently
published case series revealing promising role of homoeopathy in treatment of
vitiligo. Under such circumstances, the authors consider
it very important to undertake a pragmatic trial with adequate methodological
rigor. In this prospective, open, randomized, three parallel
arms, pragmatic trial, 60 patients suffering from vitiligo will be randomized to either individualized homeopathic medicines (IH; n=20), or Psoralea corylifolia mother tincture external application (PC; n=20), or both (IH + PC; n=20). Outcomes will be measured in terms of VASI, VitiQoL, and DLQI, measured at baseline, after 3 months, and after 6 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals. |