| CTRI Number |
CTRI/2024/12/078152 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of acne in adolescents and young adults |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial using individualized homoeopathic medicines in acne vulgaris in adolescents and young adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-3781 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Beena Das |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College And Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9476091765 |
| Fax |
|
| Email |
beenadas553@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Md Sakhawat Hossain |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2, 12, Gobinda khatick road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433852961 |
| Fax |
|
| Email |
imdrhossain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Sakhawat Hossain |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2, 12, Gobinda khatick road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433852961 |
| Fax |
|
| Email |
imdrhossain@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College And Hospital 12 Gobinda Khatick Road Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College And Hospital |
| Address |
12 Gobinda Khatick Road
Kolkata
700046 |
| 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 Beena Das |
D N De Homoeopathic Medical College and Hospital |
Department of Materia Medica OPD no PG2 and Department of Skin OPD no 9
Kolkata
WEST BENGAL |
9476091765
beenadas553@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking placebo plus concomitant care |
Placebos that is identical in appearance to the verum along with the advices on general management. Each dose will be consisting of 4 cane sugar globules no.40 moistened with 90% v/v ethanol, to be taken orally on a clean tongue on empty stomach ;potencies and repetition will be
depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating , drinking, smoking , brushing teeth within 30 minutes of taking the globules and will be asked to suck globules rather than simply swallowing it. All medicines will be administered from a Good manufacturing practice
(GMP) certified firm. Concomitant care include regular cleansing of face with water and soft soap ,avoidance of oil based cosmetics water based cosmetics can be used, stress minimization, pricking should be avoided , intake of fibrous food to be encouraged, avoidance of dairy food, diet with low glycemic index. Dose: Individualized, Frequency: Individualized, Duration of therapy 16 weeks, Route of administration per oral. |
| Intervention |
Individualized homoeopathic medicines in individualized dosage plus concomitant care |
Administration of indicated individualized homoeopathic
medicines in centesimal potency. Each dose will be consisting of 4 globules (no 40) of cane sugar, medicated with a single drop of indicated medicine (preserved in 90% v/v ethanol), is to be taken orally in an empty stomach; potencies and repetition will be
depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating , drinking, smoking , brushing teeth within 30 minutes of taking the globules and will be asked to suck globules rather than simply swallowing it. All medicines will be administered from a Good manufacturing practice GMP certified firm. Concomitant care include regular cleansing of face with water and soft soap ,avoidance of oil based cosmetics water based cosmetics can be used, stress minimization, pricking should be avoided , intake of fibrous food to be encouraged, avoidance of dairy food, diet with low glycemic index Dose: Individualized, Frequency: Individualized, Duration of therapy 16 weeks, Route of administration per oral. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 10-39 years.
2. Patients of either sex and transgender.
3. Patients with acne vulgaris (ICD -11 code ED80.Z) with GAGS score (moderate, 19-30) form from 3 months or more.
4. History of typical variable skin symptoms: presence of comedones , papules ,pustules or
nodules.
5. Patient having oily texture of the skin with prominent follicular openings.
6. Typical distribution of acne at face (nose, cheeks, forehead, etc.) trunk ,back and chest.
7. Patients able to understand English/Hindi/Bengali. |
|
| ExclusionCriteria |
| Details |
1. Patient having mild GAGS 1 to 19, severe GAGS 31 to 38, to very severe GAGS more than 39, forms of acne .
2. Patient using oil based cosmetics for long period.
3. Patient who are too sick for consultation.
4. Patient denying consent or assent voluntarily.
5. Vulnerable population including unconscious ,non ambulatory, terminally or critically ill patients, mentally incompetent people.
6. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting the quality of life or any organ failure.
7. Tobacco chewing or smoking, alcoholism or any other form of substance abuse or dependence.
8. Pregnant and puerperal women, lactating mothers.
9. Self reported immune compromised state.
10. Already undergoing homoeopathic treatment for chronic diseases other than acne within the last 1 month.
11. Simultaneous participation in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Acne Grading Scale (GAGS) |
Baseline, and every month, up to 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acne-Specific Quality of Life Questionnaire (Acne-QoL) |
Baseline , and every month, up to 4 months |
| Measure Yourself Medical Outcome Profile v.2 (MYMOP-2) |
Baseline , and every month, up to 4 months |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [beenadas553@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
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