| CTRI Number |
CTRI/2025/07/091789 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of external application of Homoeopathic Mother Tincture Azadirachta indica and oral administration of Azadirachta indica dilutions in centesimal scale in treatment Acne Vulgaris |
|
Scientific Title of Study
|
A Randomised Interventional study to assess the efficacy of Azadirachta indica mother tincture externally versus its potentised preparations in centesimal scale in cases 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 |
Elangbam Chingkheinganbi |
| Designation |
Post graduate resident |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College And Research Centre |
| Address |
Speciality OPD room no.- 27 Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10 A, Sitapura Institutional Area, Goner road, Tonk road, Sitapura
Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10 A, Sitapura Institutional Area, Goner road, Tonk road, Sitapura
Jaipur
RAJASTHAN
302022
India |
| Phone |
8800859228 |
| Fax |
|
| Email |
priya3rdsep1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pushpa Kumawat |
| Designation |
Associate Professor, Department of Homoeopathic Pharmacy |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College And Research Centre |
| Address |
Dhani Nagan, Jobner, Kalwar Road, Jaipur
Speciality OPD room no. 27 Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10 A, Sitapura Institutional Area, Goner road, Tonk road, Sitapura
Jaipur
RAJASTHAN
303328
India |
| Phone |
7062207984 |
| Fax |
|
| Email |
pushpanaga88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pushpa Kumawat |
| Designation |
Associate Professor, Department of Homoeopathic Pharmacy |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College And Research Centre |
| Address |
Dhani Nagan, Jobner, Kalwar road, Jaipur
Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10 A, Sitapura Institutional Area, Goner road, Tonk road, Sitapura
Jaipur
RAJASTHAN
303328
India |
| Phone |
7062207984 |
| Fax |
|
| Email |
pushpanaga88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10 A, Sitapura Institutional Area, Goner road, Tonk road, Sitapura, Jaipur, Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10 A, Sitapura Institutional Area, Goner road, Tonk road, Sitapura, Jaipur, Rajasthan - 302022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pushpa Kumawat |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
Specialtiy OPD Room No.27, 10 A Sitapura Institutional Area , Tonk road, Goner road, Sitapur
Jaipur
RAJASTHAN |
7062207984
pushpanaga88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swasthya Kalyan Homoeopathic Medical College Institutional Ethics Committee |
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 |
HOMOEOPATHIC MEDICINE - AZADIRACHTA INDICA IN CENTESIMAL SCALE |
Oral route, Globule no. 30, Dose and repetition as per the susceptibility and requirement of the case for 3 months |
| Comparator Agent |
HOMOEOPATHIC MEDICINE - AZADIRACHTA INDICA MOTHER TINCTURE |
External application of 10 drops of mother tincture mixed with
15 ml of purified water, at night, daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
New cases of Acne vulgaris.
Patients who are not taking any medication or those who are taking other modes or allopathic treatment and are ready to stop their treatment are included after their washout period of 1 month. |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mothers will not be included in the study.
Patients suffering from any systemic illness or any advanced pathology. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help to evaluate the efficacy of Azadirachta indica in the cases of Acne Vulgaris by assessing the severity of acne lesions using the Global Acne Grading System (GAGS) score. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will help to assess and compare the efficacy of Azadirachta indica mother
tincture externally versus its potentised preparations in centesimal scale internally in
cases of Acne vulgaris. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
06/08/2025 |
| 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
|
This study is a randomised interventional study to assess the efficacy of Azadirachta indica mother tincture externally versus its potentised preparation in centesimal scale internally in cases of Acne vulgaris. The study will be conducted at Swasthya Kalyan Homoeopathic Medical College and Research Centre, Jaipur. The expected outcome is to evaluate the efficacy of Azadirachta indica by assessing the severity of acne lesions, and to assess and compare the efficacy of Azadirachta indica mother tincture externally versus its potentised preparations in centesimal scale internally in cases of Acne Vulgaris using the Global Acne Grading System (GAGS) score. The objectives of this study are to assess and compare the efficacy of Azadirachta indica mother tincture externally and its potentised preparations in Centesimal Scale internally, to assess the efficacy of Azadirachta indica mother tincture externally, and to assess the efficacy of potentised preparations of Azadirachta indica in Centesimal scale internally in cases of Acne Vulgaris using the Global Acne Grading System (GAGS). The total sample size is 68 participants. This study will be conducted for 1 year. |