| CTRI Number |
CTRI/2025/08/093614 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To treat the Acne vulgaris by using single homoeopathic medicine in the patients from the age group 15-35 years in both sexes |
|
Scientific Title of Study
|
EFFICACY OF INDIVIDUALISED HOMOEOPATHIC MEDICINE
PRESCRIBED USING CONCEPTUAL IMAGE IN THE
MANAGEMENT OF ACNE VULGARIS ASSESSED BY GLOBAL
ACNE GRADING SYSTEM SCALE – AN EXPERIMENTAL
UNCONTROLLED DESIGN. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Minakshi Ashok Potdar |
| Designation |
PhD scholar |
| Affiliation |
SJPES HMC KOLHAPUR |
| Address |
Department of organon of medicine,SJPES HMC TARARANI CHOWK,KAWALA NAKA KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9890795034 |
| Fax |
|
| Email |
drminakshi.potdar113@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind Gaikwad |
| Designation |
Associate Professor |
| Affiliation |
SJPES HMC KOLHAPUR |
| Address |
Department of organon of medicine,SJPES HMC TARARANI CHOWK,KAWALA NAKA KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9422051639 |
| Fax |
|
| Email |
milind_sneh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Minakshi Ashok Potdar |
| Designation |
PhD scholar |
| Affiliation |
SJPES HMC KOLHAPUR |
| Address |
Department of organon of medicine,SJPES HMC TARARANI CHOWK,KAWALA NAKA KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
09890795034 |
| Fax |
|
| Email |
drminakshi.potdar113@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Minakshi Ashok Potdar |
| Address |
Department of Organon of medicine, SJPES, omoeopathic medical college, Kolhapur |
| Type of Sponsor |
Other [(self)] |
|
|
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 |
| Dr Minakshi Ashok Potdar |
SJPES homoeopthic medical college, Kolhapur |
DEPARTMENT OF ORGANON OF MEDICINE, SJPES HMC TARARANI CHOWK,KAWALA NAKA KOLHAPUR
Kolhapur
MAHARASHTRA |
09890795034
drminakshi.potdar113@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of SJPES Homoeopathic medical college |
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 |
single dose of individualised homoeopathic medicine oarally in the form of pills during First prescription and follow up after 1 month or as per requirement of patient for 6 months or till improvement which is earlier |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from acne vulgaris with parameters given in ICD 11-MMS have been taken for the study.
2.Patients between age group from 15 to 35 years suffering from acne vulgaris.
3.Patients suffering from PCOD
4.Patients having seborrheic dermatitis. |
|
| ExclusionCriteria |
| Details |
1.Patients below age 15 yrs and above 35 yrs are excluded from study.
2.Patients with k/c/o other systemic disorder like diabetes, thyroid problem etc.
3.Patients with k/c/o autoimmune disorders.
4.Acne vulgaris complicated with other skin diseases.
5.Pregnant and lactating mothers.
6.Patients suffering from Psoriasis.
7.Patients suffering from depression |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.By observing the changes after treatment in clinical findings.
2pre treatment and post treatment findings of GAGS score of the patients will be verified and assessed by using appropriate standerdised statistical tests. |
After minimum 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drminakshi.potdar113@gmail.com].
- For how long will this data be available start date provided 06-12-2028 and end date provided 01-12-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is non controlled experimental study aims to evaluate the efficacy of individualized homoeopathic medicine prescribed after using conceptual image in the treatment of acne vulgaris.in this study the conceptual image is used to find out the individualized homoeopathic remedy in cases of acne vulgaris. The study seeks to explore the complete picture of individual suffering from acne vulgaris which include not only physical complaints but his mind ,constitution and miasm also. During the study the pre and post treatment findings of GAGS score of the patients will be recorded and verified and assessed after 6 months for final outcome assessment. |