| CTRI Number |
CTRI/2019/10/021712 [Registered on: 18/10/2019] Trial Registered Prospectively |
| Last Modified On: |
18/08/2022 |
| 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 medicines for eczema |
|
Scientific Title of Study
|
A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1241-7121 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjukta Mandal |
| Designation |
Postgraduate Trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal |
| Address |
Dept. of Materia Medica, OPD No. 6 and 9 (PG OPD), Drainage Canal Road, Doomurjola
Haora
WEST BENGAL
711104
India |
| Phone |
8981702402 |
| Fax |
|
| Email |
m.sanjukta@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bulu Saha |
| Designation |
Professor and Head |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal |
| Address |
Dept. of Materia Medica, OPD No. 6, Drainage Canal Road, Doomurjola
Haora
WEST BENGAL
711104
India |
| Phone |
9051066612 |
| Fax |
|
| Email |
bulusaha52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal |
| Address |
Dept. of Pathology and Microbiology, OPD No. 3 (Medicine III), Drainage Canal Road, Doomurjola
Haora
WEST BENGAL
711104
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Govt. of West Bengal; Drainage Canal Road, Doomurjola, Howrah 711104, West Bengal |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College Hospital Govt of West Bengal |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104, West Bengal |
| 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 |
| Sanjukta Mandal |
Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Govt. of West Bengal |
Dept. of Materia Medica, OPD No. 6 and 9 (PG OPD), Drainage Canal Road, Doomurjola
Haora
WEST BENGAL |
8981702402
m.sanjukta@yahoo.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: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic
medicines in centesimal
potencies and in individualized dosage |
Intervention is planned as administering indicated homeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 globules (no. 20) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with 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. Patients will be instructed to maintain local hygiene. Duration of therapy: 6 months. |
| Comparator Agent |
Placebo, indistinguishable in
appearance from verum |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 6-8 globules (no. 20) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be instructed to maintain local hygiene. Duration of therapy: 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed cases of AD (ICD-10-CM code L20.9) as per UK diagnostic criteria
2. PO-SCORAD more than 10
3. Age: 18-65 years
4. Both sexes
5. Literate patients; ability to read Bengali
6. Patients giving written consent to participate
7. Patients already undergoing treatment for AD were planned to be recruited on completely stopping the medicines and after wash-out phase of 1 month |
|
| ExclusionCriteria |
| Details |
1. Patients who were too sick for consultation
2. Diagnosed cases of unstable psychiatric or uncontrolled or life-threatening systemic illness affecting QoL or any organ failure
3. Substance abuse and/or dependence
4. Pregnant and lactating women
5. Patients undergoing homeopathic treatment for any chronic disease within last 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient-oriented Scoring of Atopic Dermatitis (PO-SCORAD) |
At baseline, and every month up to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatological Life Quality Index (DLQI) questionnaire |
At baseline, and every month up to 6 months |
| Atopic Dermatitis Burden Scale for Adults (ADBSA) |
At baseline, and every month up to 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 2 |
|
Date of First Enrollment (India)
|
21/10/2019 |
| Date of Study Completion (India) |
18/06/2021 |
| 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
Modification(s)
|
Atopic dermatitis (AD) is a chronic, relapsing condition, caused by gene interaction, and immunological, environmental and pharmacological abnormalities. Since last four decades, rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, research evidences are inadequate. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in treatment of AD. In this 6-months, double-blind, randomized, placebo-controlled trial (n=60), patients were randomized to receive either IHMs (n=30) or identical-looking placebos (n=30). Primary outcome measure was Patient Oriented Scoring of Atopic Dermatitis (PO-SCORAD); secondary outcomes were Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) – all were measured at baseline and every month, up to 6 months. Group differences were calculated on intention-to-treat sample. After 6 months of intervention, group differences became statistically significant favoring IHMs against placebos on the primary outcome. Group differences on the secondary outcomes, though favored homeopathy, still were non-significant. Thus, IHMs performed significantly better than placebos in treatment of AD in adults. |