| CTRI Number |
CTRI/2025/02/080102 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Individualized Homoeopathic Medicine in LM Potency for the Management of Acne Vulgaris |
|
Scientific Title of Study
|
Utility of Individualized Homoeopathic Medicine in LM Potency for 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 Neelu |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homeopathic Medical college and Hospital, viraj khand 1, Gomtinagar, Lucknow |
| Address |
OPD -02 Department of Organon of Medicine State National Homeopathic Medical college and Hospital, viraj khand 1, Gomtinagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9956196601 |
| Fax |
|
| Email |
millie210395@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitesh Kumar Singh |
| Designation |
BHMS, MD (PSYCHIATRY), PhD (Homoeopathy) |
| Affiliation |
State National Homoeopathic Medical college and Hospital, viraj khand 1, Gomtinagar, Lucknow |
| Address |
Department of Practice of Medicine State National Homoeopathic Medical college and Hospital, viraj khand 1, Gomtinagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8874073232 |
| Fax |
|
| Email |
dramitesh04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelu |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homoeopathic Medical college and Hospital, viraj khand 1, Gomtinagar, Lucknow |
| Address |
OPD -02 Department of Organon of Medicine State National Homoeopathic Medical college and Hospital, viraj khand 1, Gomtinagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9956196601 |
| Fax |
|
| Email |
millie210395@gmail.com |
|
|
Source of Monetary or Material Support
|
| Outpatient and Inpatient Department of State National Homoeopathic Medical College and Hospital viraj khand 1 Gomti Nagar Lucknow Uttar Pradesh 226010 |
|
|
Primary Sponsor
|
| Name |
Neelu |
| Address |
Department of Homoeopathic Organon of Medicine of State National Homoeopathic Medical College and Hospital viraj khand 1 Gomti Nagar Lucknow 226010 |
| 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 Neelu |
State National Homoeopathic Medical College and Hospital viraj khand 1 Gomti Nagar Lucknow |
OPD - 02
Department of Organon of Medicine
Lucknow
UTTAR PRADESH |
9956196601
millie210395@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State National Homoeopathic Medical College and Hospital Lucknow |
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 |
NIL |
NIL |
| Intervention |
Utility Of Individualized Homoeopathic Medicine In LM Potency For The Management Of Acne Vulgaris |
Patients qualifying to inclusion criteria will be included in the study. Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in State National Homoeopathic medical college and hospital Lucknow. Homoeopathic medicines in LM potency will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization. Indicated homoeopathic medicine in LM potency starting with 0/1 will be administered as decided appropriate to the case or condition in appropriate doses. Medicines will be given oral route. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement. Patient will be studied for 6 months after enrolment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication in LM potency based on Global Acne Grading System. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 12-40 years old.
2.Participants must have a clinical diagnosis of acne vulgaris based on physical examination and/or standard acne grading systems (such as the Global Acne Grading System (GAGS).
3.Skin type: All skin types (normal, oily, combination, sensitive)
4.Sex: Both males and females
5.Willingness: Participants must provide informed consent, adhere to study protocols, and attend scheduled visits.
6.Participants must not have used any oral antibiotics, topical retinoids, oral isotretinoin, or topical corticosteroids.
7.Menstrual cycle: Females with regular menstrual cycles. |
|
| ExclusionCriteria |
| Details |
1.Other skin conditions except acne vulgaris.
2.Presence of endocrine disorders or PCOS affecting acne.
3.Pregnant or breastfeeding women.
4.Participants with psychiatric conditions.
5.Non-compliance with the study protocol or unwillingness to follow homoeopathic treatment instructions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the utility of Individualized Homeopathic Medicine in LM Potency for the management of Acne Vulgaris by Using Global Acne Grading System
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the utility of Individualized Homeopathic Medicine in LM Potency for the management of Acne Vulgaris by Using Global Acne Grading System
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/02/2025 |
| 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="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
|
Acne vulgaris is a persistent inflammatory skin condition affecting the pilosebaceous unit, characterized by papules, pustules, and nodules primarily on the face, but also potentially impacting the upper arms, trunk, and back. While predominantly affecting adolescents, acne vulgaris can also occur across various age groups. This study aims to demonstrate the long-term utility of individualized homoeopathic medicine in LM potencies for managing acne vulgaris, as measured by the Global Acne Grading System (GAGS).
|