CTRI Number |
CTRI/2019/02/017576 [Registered on: 11/02/2019] Trial Registered Prospectively |
Last Modified On: |
08/06/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Homeopathic treatment of eczema |
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in treatment of atopic dermatitis in adults: a double blind, randomized, placebo controlled trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1224-1365 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Abdur Rahaman Shaikh |
Designation |
Undergraduate Student |
Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
Address |
12, Gobinda Khatick Road, Kolkata-700046
Kolkata WEST BENGAL 700046 India |
Phone |
7501030842 |
Fax |
|
Email |
abdurrahamanshaikh6@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Samit Dey |
Designation |
Lecturer |
Affiliation |
D.N.De Homoeopathic Medical College and Hospital |
Address |
Department of Repertory, OPD room no. 3, 12, Gobinda Khatick Road, Kolkata, West Bengal, India
Kolkata WEST BENGAL 700046 India |
Phone |
9875371414 |
Fax |
|
Email |
dr.samit@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Samit Dey |
Designation |
Lecturer |
Affiliation |
D.N.De Homoeopathic Medical College and Hospital |
Address |
Department of Repertory, OPD room no. 3, 12, Gobinda Khatick Road, Kolkata, West Bengal, India
Kolkata WEST BENGAL 700046 India |
Phone |
9875371414 |
Fax |
|
Email |
dr.samit@yahoo.com |
|
Source of Monetary or Material Support
|
D. N. De Homoeopathic Medical College & Hospital; 12, Gobinda Khatick Road,
Kolkata-700046; West Bengal |
|
Primary Sponsor
|
Name |
D N De Homoeopathic Medical College and Hospital |
Address |
OPD room 1; 12, Gobinda Khatick Road, Kolkata-700046; 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 |
Abdur Rahaman Shaikh |
D. N. De Homoeopathic Medical College & Hospital |
OPD room no 1, 12, Gobinda Khatick Road, Kolkata-700046 Kolkata WEST BENGAL |
7501030842
abdurrahamanshaikh6@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: L209||Atopic dermatitis, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Indicated homeopathic medicine in centesimal potency |
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. 10) of cane sugar, medicated with a single drop of 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. Duration of therapy: 3 months. |
Comparator Agent |
Placebo |
This arm will receive placebo, indistinguishable from verum. Each dose of placebo shall consist of 6-8 non-medicated globules (no. 10) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 3 months. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patients of 18-65 yrs of age
2. Both sexes
3. Suffering from atopic dermatitis as per UK diagnostic criteria for atopic dermatitis and POSCORAD more than 10
4. Patients already undergoing treatment for atopic dermatitis may be recruited on completely stopping medicine and after wash-out phase of 1 month
5. Literate patients
6. Signed written informed consent to participate |
|
ExclusionCriteria |
Details |
1. Patients too sick for consultation
2. Diagnosed case of unstable or psychiatric illness affecting quality of life (QoL)
3. Uncontrolled or life-threatening illness affecting QoL or any organ failure
4. Substance abuse and/or dependence
5. Pregnant and lactating women
6. Undergoing homoeopathic treatment for any chronic disease within last 6 months |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Patient Oriented Score of Atopic Dermatitis (PO-SCORAD) |
At baseline, and every month up to 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Dermatology Life Quality Index (DLQI) |
At baseline, and every month up to 3 months |
Atopic Dermatitis Burden Scale for Adults (ADBSA) |
At baseline, and every month up to 3 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)
|
13/02/2019 |
Date of Study Completion (India) |
29/05/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" 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, pruritic, inflammatory skin disease having significant impact on the quality of life (QoL) and public health costs. Despite the fact that the evidences favouring homeopathy in AD is unconvincing, and based mostly on experience or anecdotal data, it is still highly popular. We evaluated whether individualized homeopathic medicines (IH) have significant effect beyond placebo in treatment of AD. A double-blind, randomized (1:1), two parallel arms, placebo-controlled trial (n=60) was conducted at D. N. De Homoeopathic Medical College and Hospital, West Bengal. Primary outcomes were patient-oriented scoring of AD (PO-SCORAD); secondary outcomes were dermatological life quality index (DLQI), and AD burden score for adults (ADBSA); measured at baseline, and every month, up to 3 months. Effect sizes (Cohen’s d, means adjusted for differences of baseline values) were calculated on intention-to-treat sample to detect group differences. Nine patients dropped out (IH: 3, Placebo: 6). Though intra-group changes were significant, between-group differences in PO-SCORAD, DLQI and ADBSA scores were non-significant (all P > 0.05, unpaired t test) except DLQI at month 1 (mean difference 1.3, 95% confidence interval (CI) 0.2 to 2.2, P = 0.019, unpaired t test, Cohen’s d = 0.6). Group difference on DLQI after 3 months (mean difference 1.9, 95% CI -0.1 to 3.9, P = 0.064, unpaired t test, Cohen’s d = 0.5) was near significant. Although the improvements produced by IH were higher than placebo, group differences were mostly non-significant. The trial being underpowered and of short duration, cautious interpretation is necessary. |