| CTRI Number |
CTRI/2026/01/102394 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy Other (Specify) [Individualized Homoeopathic Management] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different Homoeopathic treatment in cases of pimples |
|
Scientific Title of Study
|
Comparative Study To Assess Efficacy Of Individualized Homoeopathic Medicine Versus Berberis Aquifolium Mother Tincture In Treating Acne Vulgaris ; Randomised Control 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 |
Dr Aishwarya Shankar Jadhav |
| Designation |
PG Scholar |
| Affiliation |
Dr J.J. Magdum Homoeopathic Medical College |
| Address |
Department of Practice of Medicine Division Homoeopathy Room no 4 Dr J J Magdum Homoeopathic Medical college shirol wadi road Laxmi Nagar Jaysingpur Tal Shirol 416101
Kolhapur MAHARASHTRA 416101 India |
| Phone |
8928014708 |
| Fax |
|
| Email |
aishwaryasunanda@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sneha Mahadeo Jogdande |
| Designation |
Guide And Assistant Professor |
| Affiliation |
Dr J.J. Magdum Homoeopathic Medical College |
| Address |
Department of Practice of Medicine Division Homoeopathy Room no.4 Dr J J Magdum Homoeopathic Medical college shirol wadi road Laxmi Nagar Jaysingpur Tal Shirol 416101
Kolhapur MAHARASHTRA 416101 India |
| Phone |
7507554241 |
| Fax |
|
| Email |
snehajogdande29@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aishwarya Shankar Jadhav |
| Designation |
PG Scholar |
| Affiliation |
Dr J.J. Magdum Homoeopathic Medical College |
| Address |
Department of Practice of Medicine Division Homoeopathy Room no.4 Dr J J Magdum Homoeopathic Medical college shirol wadi road Laxmi Nagar Jaysingpur Tal Shirol 416101
Kolhapur MAHARASHTRA 416101 India |
| Phone |
8928014708 |
| Fax |
|
| Email |
aishwaryasunanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr J J Magdum Homoeopathic Medical College Shirol Wadi Road Laxmi Nagar Jaysingpur Tal Shirol Dist Kolhapur Maharashtra 416101 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Shankar Jadhav |
| Address |
Dr J J Magdum Homoeopathic Medical College Shirol Wadi Road Laxmi Nagar Jaysingpur Tal Shirol Dist Kolhapur Maharashtra 416101 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Aishwarya Shankar Jadhav |
Dr J J Magdum Homoeopathic Medical College and Hospital |
Department of Practice of Medicine Division Homoeopathy Room no.4 Dr J J Magdum Homoeopathic Medical college shirol wadi road Laxmi Nagar Jaysingpur Tal Shirol 416101 Kolhapur MAHARASHTRA |
8928014708
aishwaryasunanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr J.J. Magdum 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 |
| Comparator Agent |
Berberis aquifolium |
Berberis Aquifolium Mother Tincture 10 to 15 Drops TID |
| Intervention |
Homoeopathic management |
Individualized Homoeopathic medicines 4 globules per dose as per potency as per individual case
Frequency as per susceptibility of individual case
Route of administration Oral
Duration of intervention 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Case Fulfilling The Case Definition With Icd 11 -Ed80.0 To Ed80.3 Of Acne Vulgaris
Patient With Active Acne , Chronic Or Recurring Acne
Age Individuals Aged 18 To 35 Years
Patient with all gender will be considered
|
|
| ExclusionCriteria |
| Details |
Severe Acne and acne Variants
Acne conglobata or Acne fulminans requiring immediate allopathic intervention.
Acne Due To Underlying Medical Condition
Secondary To Systemic And Endocrine Disorder like
Pcos Cushing Syndrome Autoimmune Condition Immuno compromised State Thyroid Disorder Etc Or Certain Medication Corticosteroid Isotretinion Therapy Within Past 6 Month
Presence of other chronic skin diseases
e.g.eczema psoriasis fungal infection etc that may interfere with acne assessment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome assessment will be done by Global Acne Grading system |
Outcome assessment will be done at
Baseline pre study GAGS Scale will be applied at 0 days
Mid study follow up will be taken at every 7 days
Post study GAGS Scale will be applied at the end of 2 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
09/02/2026 |
| 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="1" Months="6" 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 study is randomized parallel group clinical trial designed to evaluate and compare the efficacy of individualized homoeopathic medicines with Berberis aquifolium mother tincture in the management of acne vulgaris. Participants will be randomly allocated into two groups. One group will receive individualized homoeopathic treatment based on the totality of symptoms and constitutional characteristics, while the comparator group will receive Berberis aquifolium mother tincture a commonly used specific homoeopathic remedy for acne vulgaris. The study aims to assess clinical improvement in acne severity using Global Acne Grading System and overall patient response over a defined follow-up period, thereby providing evidence on the comparative effectiveness of individualized homoeopathic prescribing versus a Berberis aquifolium mother tincture. |