| CTRI Number |
CTRI/2025/05/087138 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Individualized Homoeopathic treatment of eczema |
|
Scientific Title of Study
|
The Effect of Individualized Homoeopathic Medicines in Centesimal Potency in Comparison with Fifty-Millesimal Potency in the treatment of Atopic Dermatitis in Adults :An open -Label, Randomized Double -Arm Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U11111322-7546 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukanya Banerjee |
| Designation |
PG student |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of medicine; The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal,265,266 Acharya prafulla Chandra Road, Kolkata ,West Bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
9123046739 |
| Fax |
|
| Email |
sukanyabanerjee32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.(Dr.)Himangshu Hait |
| Designation |
HOD ,Department of Practice of Medicine |
| Affiliation |
|
| Address |
Department of Practice of medicine; The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal,265,266 Acharya prafulla Chandra Road, Kolkata ,West Bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433565680 |
| Fax |
|
| Email |
drhaithait@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukanya Banerjee |
| Designation |
PG student |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of medicine; The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal,265,266 Acharya prafulla Chandra Road, Kolkata ,West Bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
9123046739 |
| Fax |
|
| Email |
sukanyabanerjee32@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Hom,oeopathic Medical College and Hospital,Govt. of West Bengal,265,266 Acharya Prafulla Chandra Road,Kolata 700009,West Bengal |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265,266 Acharya Prafulla Chandra Road,Kolkata 700009,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 |
| Dr Sukanya Banerjee |
The Calcutta Homoeopathic Medical College and Hospital |
OPD no.21;The Calcutta Homoeopathic Medical College and Hospital 265-266,APC Road,kolkata-700009
Kolkata
WEST BENGAL |
9123046739
sukanyabanerjee32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The 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 |
| Comparator Agent |
Individualized homoeopathic medicines in centesimal potencies |
Comparator arm(IHM in centesimal potency): treatment will be started from 6C,30C or 200C, as appropriate to the case and gradually increased as per homoeopathic principles. Each dose will consist of 4-6 cane sugar globules no 40,medicated with single drop of the indicated medicine preserved in 90% v/v ethanol; The required doses will be determined as per requirement of individual cases. Potencies will be increased gradually depending upon the outcomes as per homoeopathic principles dosage will be adjusted as requirement of the case. All medicines will be procured from a Good Manufacturing practice (GMP) certified firm.Medicine to be taken orally .Dose and frequency of repetition will be depended on the individual case of disease.Duration of therapy is 6 months. |
| Intervention |
Individualized homoeopathic medicines in fifty millesimal potencies |
Experimental arm(verum):Intervention is planned as administering indicated homoeopathic medicines
in 50 millesimal potencies, as decided appropriate to the case or condition. In 50 millesimal scale, each dose
shall consist of one globule no: 10 of the indicated remedy is dissolved in 120 ml (8 tablespoonful) of dist.
water with the addition of some rectified spirit then the vial is succussed and after that one tablespoon
(approx. 15ml)of the medicinal solution is taken and put in a glass of water of about 120 ml( 8
tablespoonfuls). This is stirred thoroughly and a dose (l teaspoonful) of 5ml is given to the patient,to be
taken orally in an empty stomach .Dose and repeatation depend on the individual requirement of the case
.All medicines will be procured from a Good Manufacturing practice (GMP) certified firm.Total duration of intervention is 6 months.Dose and frequency will be depended on the individual case as mentioned earlier,medicine will be taken orally.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed cases of AD(ICD-11 CODE EA80.2)nas per Hanifin Rajka diagnostic criteria,
2.SCORAD values more than 10,
3.Patients of18-65 years of age and of either sex,
4.Literate patients;ability to read Bengali and /or English
5.Patients giving written consent to participate in the trial,
6.Patients already undergoing treatment for AD were planned to be recuited on completely stopping the medicines and after wash-out phase of 1 month |
|
| ExclusionCriteria |
| Details |
1.Uncontrolled or life threatening illness,any organ failure and other comorbidities,vulnerable population-unconscious,ambulatory,
2.Patients who are too sick for consultation,differently abled,terminally ill or critically ill patients abuse and/or dependence
3.Pregnant and lactating women,puerperal mothers, psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scoring Atopic Dermatitis (SCORAD) |
At baseline,at every 4 weeks, upto 24weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatological life quality index(DLQI) |
At baseline,every 4 weeks,up to 24weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Atopic dermatitis (AD) is the most common inflammatory skin disorder, affecting up to 25percent of children and 10percent of adults, depending on the geographical area, with almost 25percent of the patients reporting symptoms only after adulthood., The characteristic clinical features of the highly pruritic eczematous lesions, consisting of papules and patches and the subsequent exudation and excoriation in the acute phase as well as the chronic lichenified, hyperpigmented lesions. It ranks as the most prevalent skin disorder based on disability-adjusted life-years by the World Health Organization. A gradual increase in the prevalence of AD has been observed recently and it can be ascribed to environmental changes consequent to rapid development all over the world. A rising trend in AD has been observed in India also in last four decades. The predominant mode of treatment in modern medicine for AD not beneficent, steroid have marked side effects. long term corticosteroid use poses risk for adverse effects like skin atrophy. The effectiveness of homoeopathic drug in managing the AD needs to be verified .However , any adequately powered clinical trial to examine the efficacy of IH in treatment of AD has been lacking till date .This current work is aimed to compare the effectiveness of fifty millesimal potencies with that of centesimal potencies of individualized homoeopathic medicines(IHMs)in atopic dermatitis in adults.A 6 months, open-label, randomized, two parallel arms, clinical trial will be conducted on 70 patients of atopic dermatitis at the outpatients of The Calcutta Homoeopathic Medical College and Hospital. Participants will be randomized to receive IHMs, either in centesimal or in fifty millesimal potencies. Scoring for atopic dermatitis (SCORAD)will be the primary outcome measure; Dermatological life quality index(DLQI)will be the secondary outcome measures ;all will be measured at baseline and every month ,up to 6 months. Parametric and non-parametric tests will be used as inferential statistics as per normality or non-normality of data distribution respectively to detect group diffrences.Results will be published in scientific journals. |