| CTRI Number |
CTRI/2025/02/080298 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of acne vulgaris |
|
Scientific Title of Study
|
A study on efficacy of individualized homoeopathic treatment through synthesis repertory in case of acne vulgaris - A single blind randomized , placebo controlled clinical trial |
| Trial Acronym |
Treatment of acne vulgaris by synthesis repertory |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhadra Kumari |
| Designation |
PGT |
| Affiliation |
R.B.T.S Govt. Homoeopathic Medical Colleeg and Hospital |
| Address |
Department of Homoeopathic Repertory and Case Taking Academic Block R.B.T.S Govt. Homoeopathic Medical College and Hospital Muzaffarpur.
Muzaffarpur
BIHAR
842002
India |
| Phone |
6205540661 |
| Fax |
|
| Email |
subhsubh111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Kumar Rai |
| Designation |
Professor |
| Affiliation |
R.B.T.S Govt. Homoeopathic Medical Colleeg and Hospital |
| Address |
Department of Homoeopathic Repertory and Case Taking Academic Block R.B.T.S Govt. Homoeopathic Medical College and Hospital Muzaffarpur.
Muzaffarpur
BIHAR
842002
India |
| Phone |
9304734197 |
| Fax |
|
| Email |
drrajeevrai16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajiv Kumar Rai |
| Designation |
Professor |
| Affiliation |
R.B.T.S Govt. Homoeopathic Medical Colleeg and Hospital |
| Address |
Department of Homoeopathic Repertory and Case Taking Academic Block R.B.T.S Govt. Homoeopathic Medical College and Hospital Muzaffarpur.
Muzaffarpur
BIHAR
842002
India |
| Phone |
9304734197 |
| Fax |
|
| Email |
drrajeevrai16@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.B.T.S. Govt. Homoeopathic Medical College And Hospital Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Govt Homoeopathic Medical College And Hospital Muzaffarpur Bihar |
| Address |
R.B.T.S. Govt. Homoeopathic Medical College And Hospital Muzaffarpur Bihar india 842002 |
| Type of Sponsor |
Government 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 Subhadra Kumari |
R.B.T.S Govt. Homoeopathic Medical College and Hospital |
OPD 1 Medicine Dept,OPD 5 Organon Dept, OPD 6 Materia medica Dept, OPD 7 Repertory Dept R.B.T.S Govt. Homoeopathic Medical College and Hospital Muzaffarpur Bihar India 842002
Muzaffarpur
BIHAR |
6205540661
subhsubh111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RBTS Govt Homoeopathic Medical College and Hospital |
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 |
Individualised Homoeopathic Medicine through Synthesis Repertory given orally to the patient who is suffering from Acne Vulgaris in 6C 30C 200C 1M 10M & LM Potency. Dose of medicine is selected according to susceptibility of patient. The Patient was called for follow-up every 15 days. |
| Comparator Agent |
Placebo |
Other group of patient take placebo. And changes will be observe every 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient conforming with ED80.Z criteria of ICD 11.
Patient of age group 18 years to 45 years. Patients of both Male & Female. Patient who gives their written consent for participation.Individual of both sexes, all religions, all socio-economic conditions.
|
|
| ExclusionCriteria |
| Details |
Cases suffering from uncontrolled systematic illness or life-threatening infections. .Unwilling to take part and not giving consent to join the study. Diagnosed case of unstable mental or psychiatric illness affecting quality of life.
Pregnant women and lactating mother. Self-Reported immunocompromised state and undergoing homoeopathic treatment for any chronic disease.
Illiterate patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the individualised homoeopathic medicine through Synthesis Repertory have any different effect in the treatment of acne Vulgaris |
3 to 4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To demonstrate how much patients able to improve their quality of life and through GAGS SCORE. To ascertain the reliable indication of effective medicine |
3 to 4 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
19/02/2025 |
| 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 Yet Recruiting |
| 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
|
The term acne derived from the Greek word “acne” which is used in the sense of skin eruptions and “vulgara” indicates the meaning commons. It is multifunctional disease affecting pilosebaceous follicle and inflammatory papules, pustules, modules and cysts. By using individualiased Homoeopathic Medicine through the help of Synthesis Repertory to select homoeopathic remedies, administered according to homoeopathic principles, will prove effective in managing acne vulgaris and halting the disease’s progression. This approach could lead to the development of affordable treatment recommendations as alternatives to the conventional mode of treatment with no side effect
|