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CTRI Number  CTRI/2024/05/066805 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment of Acne vulgaris 
Scientific Title of Study   Effect of predetermined carbon group remedies in treatment of acne vulgaris: a pre-post clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paulami Sarkar 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy 
Address  Department of Homoeopathic Materia Medica, GE Block, Sector-III, Bidhannagar, Kolkata- 700106

Kolkata
WEST BENGAL
700106
India 
Phone  9732977043  
Fax    
Email  paulamisarkar9046@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratima Pal 
Designation  Assistant Professor 
Affiliation  National Institute of Homoeopathy 
Address  Department of Homoeopathic Materia Medica, GE Block, Sector-III, Bidhannagar, Kolkata- 700106

Kolkata
WEST BENGAL
700106
India 
Phone  7679507608  
Fax    
Email  dr.pratimapal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratima Pal 
Designation  Assistant Professor 
Affiliation  National Institute of Homoeopathy 
Address  Department of Homoeopathic Materia Medica, GE Block, Sector-III, Bidhannagar, Kolkata- 700106


WEST BENGAL
700106
India 
Phone  7679507608  
Fax    
Email  dr.pratimapal@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, GE Block, Sector- III, Bidhannagar, Kolkata- 700106 
 
Primary Sponsor  
Name  National Institute of Homoeopathy 
Address  GE Block, Sector- III, Bidhannagar, Kolkata- 700106 
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 
Dr Paulami Sarkar  National Institute of Homoeopathy  OPD Department of Homoeopathic Materia Medica(Room no.-18) GE Block, Sector- III, Bidhannagar, Kolkata- 700106
Kolkata
WEST BENGAL 		 9732977043

paulamisarkar9046@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of National Institute of Homoeopathy  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  Carbo animalis, Carbo vegetabilis and Carboneum sulphuratum  Intervention is planned as administering indicated predetermined carbon group of drugs (Carbo animalis, Carbo vegetabilis and Carbonium sulphuratum) either in Centesimal or Fifty Millesimal potencies, as decided appropriate to case or condition. In case of Centesimal potency, the medicine will be prescribed as each dose of the medicine consisting of 4 cane sugar globules of no. 30 moistened with the indicated homoeopathic medicine. While the Fifty Millesimal potency dispensed as one poppy seed size cane sugar globule of no. 10 moistened with the indicated homoeopathic medicine will be dissolved in 120ml of distilled water and 1 drop of rectified spirit will be added. This preparation will be divided into suitable doses. Dosage and repetition will be decided depending upon the individual requirement of the cases. Patient will be advised to take the medicine orally in empty stomach. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) - certified firm. Non pharmacological general management will not be given to the patient as there is no control arm. Each case will be followed up monthly and also as per requirements of the patient. Duration of therapy six months. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.All the patients clinically diagnosed as having Acne vulgaris (ED80.Z).
2.Patients of both sexes between age group of 12-30 years.
3.Patients suffering from Acne vulgaris willing to participate and take treatment regularly and co-operating for regular follow-up will be included.
4.Acne vulgaris patients, after individualization most similar remedy found in any of the three predetermined carbon group of remedies (Carbo animalis, Carbo vegetabilis and Carboneum sulphuratum).
5.Patients knowing Bengali/English/Hindi.
 
 
ExclusionCriteria 
Details  1.Patients of acne scars with co-morbid skin conditions like Psoriasis, Lichen planus, eczema etc.
2.Acne patients diagnosed with unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
3.Patient with substance abuse and/or dependence.
4.Patients under treatment with OCP, IUCD or NSAIDs.
5.Pregnant and lactating mothers.
6.Patient under the treatment of any other acne therapy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Global Acne Grading System (GAGS)  Baseline, 3rd month and 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
Cardiff Acne Disability Index (CADI)  Baseline, 3rd month and 6th month 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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 
Date of First Enrollment (India)   12/05/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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

  3. 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.

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [paulamisarkar9046@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    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 - NA
Brief Summary  
Acne vulgaris is a persistent chronic skin inflammatory condition affecting people all over the world, mostly adolescents and young adults. The Global Burden of Disease Study found that acne vulgaris is the eighth most common skin disease, with an estimated global prevalence (for all ages) of 9.38%. The visual appearance of acne and its sequelae, including scarring and pigment changes, frequently results in significant social and psychological morbidity with an increased risk of anxiety, depression, and suicidal ideation. Complementary and alternative medicines (CAM) are of increasing interest to people in acne therapy and generally regarded as safe. After thorough search in different databases few trials were identified regarding homoeopathic approach in acne management. Various homoeopathic literatures highly advocate the use of Carbo animalis, Carbo vegetabilis and Carboneum sulphuratum for treating acne cases. However in clinical practice these remedies are seldom used in acne therapy. Under such cicumstances, we intend to undertake a pre-post clinical trial to find out the effect of potentised homoeopathic medicine of carbon group namely Carbo animalis, Carbo veg and Carboneum sulphuratum as individualized homoeopathic medicines (IHMs) in cases of Acne vulgaris. A prospective, open label, single arm, pre-post clinical trial will be conducted on 39 participants of age group 12-30 years with complaints of acne vulgaris. The objectives are to detect the changes in Global Acne Grading System (GAGS), Cardiff Acne Disability Index (CADI) score at baseline, 3rd month and at 6 months and to analyse the comparative changes in mild, moderate, severe and very severe form of acne vulgaris with predetermined carbon group of remedies. The statistical analysis plan will follow the intension-to treat (ITT) approach. The score obtained from the patient on the said validated instrument before and after treatment will be compared and results will be analysed by using paired z-test. The result will be published in scientific journals.
 
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