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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  
Name  Address 
None  NA 
 
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  
Status 
Not Applicable 
 
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.

 
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