| CTRI Number |
CTRI/2025/03/082231 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic medicines for Acne vulgaris |
|
Scientific Title of Study
|
THE EFFECT OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN CENTESIMAL POTENCY IN COMPARISON WITH 50-MILLESIMAL POTENCY FOR THE TREATMENT OF PATIENTS HAVING ACNE VULGARIS: AN OPEN LABEL, RANDOMIZED DOUBLE-ARM STUDY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1319-4217 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita Panja |
| Designation |
Post Graduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
DEPARTMENT OF PRACTICE OF MEDICINE 265 266 Acharya Prafulla Chandra Road Kolkata
Kolkata WEST BENGAL 700009 India |
| Phone |
8420915919 |
| Fax |
|
| Email |
amrita1995panja@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rajat Chattopadhyay |
| Designation |
PRINCIPAL and ADMINISTRATOR |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
DEPARTMENT OF PRACTICE OF MEDICINE 265 266 Acharya Prafulla Chandra Road Kolkata
Kolkata WEST BENGAL 700009 India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rajat Chattopadhyay |
| Designation |
PRINCIPAL and ADMINISTRATOR |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
DEPARTMENT OF PRACTICE OF MEDICINE 265 266 Acharya Prafulla Chandra Road Kolkata
Kolkata WEST BENGAL 700009 India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, 265, 266 Acharya Prafulla Chandra Road, Kolkata - 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 |
| AMRITA PANJA |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PRACTICE OF MEDICINE, ROOM NO 17 AND 21, 265, 266 Acharya Prafulla Chandra Road, Kolkata - 700009, West Bengal Kolkata WEST BENGAL |
8420915919
amrita1995panja@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: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individual Homoeopathic Medicine in 50 millesimal potency |
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 one globule no. 10 of the indicated remedy is dissolved in 120 ml (8 tablespoonful) of dist. water with 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 tablespoonful). This is stirred thoroughly and from it a dose l teaspoonful (approx. 5ml) is given to the patient, to be taken orally in empty stomach. Dose and repetition depending up on the individual requirement of the case. patients are advised to refrain from taking tea, coffee, alcoholic beverages like whisky, brandy etc, and foods possessing medicinal qualities like onion, pepper, cloves, cinnamon, ginger, and bitter substance, old rancid foods etc. All medicines will be procured from a Good Manufacturing practice (GMP) certified firm. |
| Intervention |
Individual Homoeopathic Medicine in Centesimal Potency |
Intervention is planned as administering indicated homoeopathic remedies in centesimal potency. Each dose consisted of 1 cane sugar globule moistened with the indicated medicine, 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. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. All the patients clinically diagnosed as having Acne vulgaris [ICD11 code: ED80] characterised by comedones papules, pastules, nodules on face and trunk.
2. Age 10 to 50 years.
3. Both sexes and transgenders.
4. Patients giving written informed consent (for ages 18 to 50 years)/assent (for ages 10 to 17 years) to participate.
5. Patients with known but controlled systemic disease. |
|
| ExclusionCriteria |
| Details |
1. Patients not giving written informed assent and/or consent to participate.
2. Patients using oil-based cosmetics for 6 months.
3. Patients under hormonal treatments.
4. Co-morbid skin conditions like Psoriasis, Lichen planus, eczema etc.
5. Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent people.
6. Pregnant and puerperal women and lactating mothers.
7. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
8. Substance abuse or dependence.
9. Self-reported immune-compromised state.
10. Undergoing homoeopathic treatment for any chronic disease within the last 6 months.
11. Simultaneous participation in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the effects of individualised homoeopathic medicines prescribed in centesimal potency with individualised homoeopathic medicines prescribed in 50-millesimal potency. |
At the baseline, and every one month up to 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of life quality index.
2. Finding out multifactorial causation. |
At the baseline, and every one month up to 3 months. |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
18/03/2025 |
| 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) |
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
|
Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition typically manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. Along with its polymorphic clinical presentations, it has the potential to cause varying degree of scarring. Recent research has provided insights into the role of the sebaceous gland and the pro-inflammatory activity of the cutaneous microbiome. During puberty, alteration of the sebaceous lipid profile, called dysseborrhoea, stress, irritation, use of cosmetics and potential dietary factors lead to inflammation and formation of different types of acne lesions. Additionally, dysbiosis, the process leading to a disturbed skin barrier and disequilibrium of the cutaneous microbiome, resulting in the proliferation of P. acnes strains, is another important process that triggers acne. Following screening using specific selection (inclusion and exclusion criteria) criteria and obtaining consent, eligible 90 participants will be included in the trial (45 in each group). Individualized Homoeopathic medicines will be prescribed either in Centesimal potency or 50-millesimal (as per random number chart) after proper Case-taking, consultation with Materia medica and Repertory. Following that, the outcomes will be assessed initially at the baseline, and every one month up to 3 months, as per GAGS score, CADI scale and DLQI scale. |