| CTRI Number |
CTRI/2021/02/031519 [Registered on: 24/02/2021] Trial Registered Prospectively |
| Last Modified On: |
24/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathy in pimples |
|
Scientific Title of Study
|
Individualized homeopathic medicines in treatment of acne vulgaris: Double-blind,
randomized, placebo-controlled, pilot trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1264-6335 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satyajit Naskar |
| Designation |
Lecturer, Dept. of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Research OPD, Room no 12; 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata WEST BENGAL 700046 India |
| Phone |
8981859153 |
| Fax |
|
| Email |
satya.naskar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Shyamal Kumar Mukherjee |
| Designation |
Principal and Administrator |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Principals Chamber, Administrative Division, 12, Gobinda Khatick Road, Kolkata
Kolkata WEST BENGAL 700046 India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rithika Padhi |
| Designation |
3rd BHMS undergraduate student |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Research OPD, room no. 12, 12, Gobinda Khatick Road, Kolkata
Kolkata WEST BENGAL 700046 India |
| Phone |
7063999639 |
| Fax |
|
| Email |
rithikapadhi853@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra,
Kolkata, West Bengal 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 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 |
| Satyajit Naskar |
D. N. De Homoeopathic Medical College and Hospital |
Research OPD, Room no 12; 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 Kolkata WEST BENGAL |
8981859153
satya.naskar@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: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine |
It is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition. Each dose shall consist of 4 globules (no. 30) 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 given general advices on intake of adequate water and maintaining local hygiene. Regular gentle cleansing with mild soap and water will be encouraged. Use of water based cosmetics instead of oil based cosmetics will be encouraged. Psychological counselling will be given to reduce stress. Duration of therapy: 2 months. |
| Comparator Agent |
Placebo |
Placebo, identical in appearance with and indistinguishable from
the medicine. Each dose of placebo shall consist of 4 globules (no. 30) 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. All sundry items will be procured from a Good
Manufacturing Practice
(GMP)-certified firm. Route of
administration: Oral. Patients will be given general advices on intake of adequate water and maintaining local hygiene. Regular gentle cleansing with mild soap and water will be encouraged. Use of water based cosmetics instead of oil based cosmetics will be encouraged. Psychological counselling will be given to reduce stress. Duration of therapy: 2 months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from acne vulgaris (2020 ICD-10-CM Diagnosis Code L70.0)
2. Patients of either sex
3. Patients of age between 12 and 30 years
4. Patients who are literate and capable of filling the questionnaire and providing
written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients having severe form of acne vulgaris (GAGS 31 or higher)
2. Patients using oil based cosmetics for long periods of time
3. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled
or life – threatening illness affecting quality of life or any organ failure
4. Pregnancy, puerperium and lactation
5. Substance abuse and/or dependence
6. Self-reported immune-compromised state
7. Undergoing homeopathic 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, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Acne Grading System (GAGS) |
At baseline and after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiff Acne Disability Index |
At baseline and after 2 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
24/02/2021 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet, to be published |
|
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 Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included www.dndeofficial.org/).
- For how long will this data be available start date provided 01-12-2021 and end date provided 30-11-2026?
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
|
|
Brief Summary
|
Acne vulgaris is a follicular disorder affecting susceptible pilo-sebaceous follicles, primarily of the face, neck, and upper trunk and characterized by both non-inflammatory and inflammatory lesions. It is estimated to affect 9.4% of the global population with 10-20% of some form of disorder, making it the 8th most prevalent disease worldwide and thus affect quality of life (QoL). Topical agents and synthetic retinoid isetretinoin often produce excellent results. But its use is highly regulated due to its potential for severe adverse events, primarily tetragenocity, depression, xerosis, cheilitis and occasional hypertriglyceridemia. Various complementary and alternative medicine (CAM) modalities have been introduced and found to have an important role in management of acne; however, their recommendation for treatment is limited by lack of large-scale studies and evidence about their efficacy and safety profile. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 40 patients suffering from acne vulgaris will be randomized to receive either individualized homeopathic medicines (verum; n=20) or identical-looking placebo (control; n=20). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homoeopathy in treatment of acne vulgaris and to investigate whether there are any differences in outcomes between these two groups over 2 months of intervention. Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI) will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals. |