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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  
Name  Address 
None  NA 
 
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  
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  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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included www.dndeofficial.org/).

  6. 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.

  7. 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.

 
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