| CTRI Number |
CTRI/2025/09/094461 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness Of Homoeopathic Medicines in Acne |
|
Scientific Title of Study
|
An Open Label Prospective Study On The Effectiveness Of Individulaized Homoeopathic Medicine In The Management Of Acne Vulgaris |
| 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 Roshni Chaurasia |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department Of Materia Medica Nehru Homoeopathic Medical College and Hospital,B-Block defence colony
South
Delhi
110024
India
11
South
DELHI
110024
India |
| Phone |
9044725880 |
| Fax |
|
| Email |
roshanichaurasiaaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Rai |
| Designation |
Professor/Principal |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica Nehru Homoeopathic Medical College and Hospital, defence colony,new Delhi,110024
South
DELHI
110024
India |
| Phone |
8076105535 |
| Fax |
|
| Email |
principalnhmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Rai |
| Designation |
Professor/Principal |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica Nehru Homoeopathic Medical College and Hospital, defence colony,new Delhi,110024
South
DELHI
110024
India |
| Phone |
8076105535 |
| Fax |
|
| Email |
principalnhmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department of Nehru Homoeopathic Medical College and Hospital,B-Block,Defence Colony,New Delhi,INDIA 110024 |
|
|
Primary Sponsor
|
| Name |
Dr Roshni Chaurasia |
| Address |
Nehru Homoeopathic Medical College and Hospital,Defence Colony,New Delhi |
| 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 Roshni Chaurasia |
Nehru Homoeopathic Medical College and Hospital |
OPD no.7,Ground Floor,Hospital Block,Nehru Homoeopathic Medical College and Hospital,New Delhi,India,110024
South
DELHI |
9044725880
roshanichaurasiaaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,B-BLOCK, DEFENCE COLONY, NEW DELHI- 110024 |
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 |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE |
Intervention:Individualized homoeopathic medicine intervention to be conducted on patient suffering from acne vulgaris.A complete detailed case taking, analysis,evaluation and repertorisation will be done according to homoeopathic principles and then the final individualized homoeopathic medicine will be given.Mode ofadministration will be oral.Dose,Frequency,Repetition:Depending upon severity of.symptoms,susceptibility of the patient according to homoeopathic principles. Total Duration of Intervention:Each case will be given Individualized Homoeopathic Medicine for 4 months.Follow up:Follow up of cases will be done every 2 weeks till 4 months and depending upon the severity of the symptoms and as per the need and necessity of the case. |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants suffering from acne(ICD-10-CM code:L-70) ,mild (GAGS- 1-18) to moderate(GAGS 19-30) from 3 months or more
2.Participants of age group 15 -24 years
3.Participants of either sex
4.Skin type: All skin types (normal, oily, combination, sensitive)
5.Participants willing to give written consent
6. Literate patients who can read and write in English and/or Hindi.
|
|
| ExclusionCriteria |
| Details |
1.Cases suffering from uncontrolled systemic illness or life threatening infections.
2.Self reported immunocompromised state
3.Diagnosed case of unstable mental or psychiatric illness affecting quality of life.
4.Pregnant women and lactating mother.
5. Co-morbid skin conditions like Psoriasis, Lichen planus, eczema etc.
6.Cases with acne having association with endocrinal disorders e.g.PCOS , Cushing syndrome,Adrenal hyperplasia,etc.
|
|
|
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 SCORE). |
At baseline and after 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatology Life Quality Index(DLQI) |
At baseline and after 4 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
29/09/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Acne
is a common dermatological disease of adolescent and young adults. Through this study we want to evaluate Homoeopathic medicines
given in the literature and identify most effective medicines for the
management of acne vulgaris using Individualised Homoeopathy.
Primary Objective to evaluate the effectiveness of
Individualised Homoeopathic treatment in
the management of acne vulgaris using the GLOBAL Acne Grading System
(GAGS)score. Secondary Objective 1.To identify the most effective
Homoeopathic medicines,their reliable indications,potencies for the treatment
of acne vulgaris.
2.To evaluate the impact of
treatment on the quality of life assessed by DLQI. The duration of study will be for one year and each patient will be studied for 4 months period at Out Patient Department (OPD) of Nehru Homoeopathic Medical College and Hospital , New Delhi. Each individual case will be assessed according Global Acne Grading System (GAGS) and Disability Life Quality Index (DLQI) in patients of Acne at baseline and at months of 4 months. A complete detailed case taking, analysis, evaluation and individualisation of case and repertorisation will be done according to homoeopathic principles and then the final selection of medicine will be done after consulting standard Homoeopathic Materia Medica. After the completion of study, the result will be analysed and represented by using different statistical methods.
|