| CTRI Number |
CTRI/2026/03/106524 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of selected Homoeopathic medicines (Asterias Rubens Azadirachta Indica Eugenia Jambos and Juglans Regia) in the management of Acne. |
|
Scientific Title of Study
|
Exploring efficacy of Lesser known Homoeopathic Therapeutics (Asterias Rubens, Azadirachta Indica, Eugenia Jambos & Juglans Regia) in management of Acne : A clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pritikaben Maheshkumar Patel |
| Designation |
MD Scholar Part 2 |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari |
| Address |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari
Near Devina Park Society Gandevi Road Navsari Gujarat, 396445, PG Division, 5th Floor Homoeopathic POM Department.
Navsari GUJARAT 396445 India |
| Phone |
7567599946 |
| Fax |
|
| Email |
pritikapatel95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Endreshkumar |
| Designation |
Associate Professor Of Practice of Medicine |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari |
| Address |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari
Near Devina Park Society Gandevi Road Navsari Gujarat, 396445, PG Division, 5th Floor Homoeopathic POM Department.
Navsari GUJARAT 396445 India |
| Phone |
9672519750 |
| Fax |
|
| Email |
endreshkatiyar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Endreshkumar |
| Designation |
Associate Professor Of Practice of Medicine |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari |
| Address |
S. S. Agrawal Homoeopathic Medical College And General Hospital, Navsari
Near Devina Park Society Gandevi Road Navsari Gujarat, 396445, PG Division, 5th Floor Homoeopathic POM Department.
Navsari GUJARAT 396445 India |
| Phone |
9672519750 |
| Fax |
|
| Email |
endreshkatiyar@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. S. Agrawal Homoeopathic Medical College and General Hospital, Navsari |
|
|
Primary Sponsor
|
| Name |
S. S. Agrawal Homoeopathic Medical College and General Hospital, Navsari |
| Address |
Near Devina Park Society, Gandevi Road, Navsari, 396445 |
| Type of Sponsor |
Private medical college |
|
|
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 Pritikaben Maheshkumar Patel |
S. S. Agrawal Homoeopathic Medical College and General Hospital, Navsari, Gujarat |
Medicine OPD, Ground floor, S.S Agrawal Homoeopathic Medical College and General Hospital near devina park society gandevi road
Navsari, Gujarat - 396445 Navsari GUJARAT |
7567599946
pritikapatel95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, S.S. AGRAWAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L709||Acne, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asterias Rubens, Azadirachta Indica, Eugenia Jambos & Juglans Regia |
Homoeopathic medicines Asterias Rubens, Azadirachta Indica, Eugenia Jambos & Juglans Regia will be prescribe on the basis of individual totality of symptoms. The dose and potency will be selected on the basis of the patient susceptibility and necessity of case. Administration will be through oral route and follow up will be taken in every 2-3 weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
According to diagnostic criteria patient of both sexes & patient’s age above 14 years to 50 years cases will be included.
|
|
| ExclusionCriteria |
| Details |
Patients of age group below 14 years and above 50 years, Patients whose GAGS scale score is more than 39 will be excluded, Patients who are pregnant and lactating will be also excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Global Acne Grading System (GAGS) score from baseline after treatment with selected homoeopathic medicines in patients with Acne vulgaris and Acne rosacea. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the symptomatic relief before and after treatment with the help of GAGS scale. |
9 month |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
25/03/2026 |
| 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="9" 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
|
This dissertation titled “Exploring efficacy of Lesser known Homoeopathic Therapeutics (Asterias Rubens, Azadirachta Indica, Eugenia Jambos & Juglans Regia) in management of Acne: A Clinical Study” is submitted to Veer Narmad South Gujarat University, Surat, as partial fulfillment for the degree of MD (Hom.) in Practice of Medicine. Acne is a chronic inflammatory disorder of the pilosebaceous unit commonly affecting adolescents and young adults, significantly impacting psychological and social well-being. Conventional treatments, though effective, are often associated with adverse effects. Homoeopathy offers a holistic and individualized approach; however, lesser-known remedies such as Asterias Rubens, Azadirachta Indica, Eugenia Jambos, and Juglans Regia, though used in clinical practice, lack sufficient scientific evaluation. This prospective experimental clinical study will be conducted at S.S. Agrawal Homoeopathic Medical College and Hospital, Navsari, including 80 cases selected through purposive sampling. Diagnosed cases of Acne Vulgaris and Acne Rosacea above 14 years of age will be assessed using the Global Acne Grading System (GAGS) before and after treatment to evaluate improvement. The study aims to determine the clinical efficacy of these lesser-known homoeopathic medicines in reducing acne severity and associated symptoms, thereby contributing evidence-based support to homoeopathic dermatological practice. |