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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.

 
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