| CTRI Number |
CTRI/2024/12/078821 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of homeopathy in teen age acne |
|
Scientific Title of Study
|
Utility of the complete repertory in management of acne
In teen age, and preparation of a repertory & visual
Therapeutics for the same
|
| 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 Vijay Parmar |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical Collage |
| Address |
Department of Case taking and Repertory, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT
360002
India
Rajkot
GUJARAT
360002
India |
| Phone |
9925481813 |
| Fax |
|
| Email |
sanjivani7372@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashyap Premasawala |
| Designation |
HOD and Professor |
| Affiliation |
Rajkot Homoeopathic Medical Collage |
| Address |
Department of Case taking and Repertory, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT
360002
India
Rajkot
GUJARAT
360002
India |
| Phone |
9727173799 |
| Fax |
|
| Email |
k2krp@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Parmar |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical Collage |
| Address |
Department of Case taking and Repertory, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT
360002
India
Rajkot
GUJARAT
360002
India |
| Phone |
9925481813 |
| Fax |
|
| Email |
sanjivani7372@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Case taking and Repertory, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot Rajkot GUJARAT 360002 India
Rajkot
GUJARAT
360002
India |
|
|
Primary Sponsor
|
| Name |
Rajkot homeopathic medical collage |
| Address |
Department of Case taking and Repertory, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot Rajkot GUJARAT 360002 India
Rajkot
GUJARAT
360002
India |
| 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 Vijay Parmar |
Rajkot Homoeopathic Medical College |
Department of Case taking and Repertory, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot Rajkot GUJARAT 360002 India
Rajkot
GUJARAT
360002
India
Rajkot
GUJARAT |
9925481813
sanjivani7372@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L70||Acne, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic
Medicine |
Individualized homoeopathic
medicine selected using
Complete repertory.
Mode of Administration: Oral
(sublingual) Selection of
potency, dose and repetition :
individualised medicine will be
presecribed in 30, 200, 1 M
potency. selection of dosage,
potency and repitition will be
according to susceptibility of
patient and principles of
organon of medicine
duration of intervention is minimum 3 months after first prescription
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria: Patients aged 13-19 years.
Both genders (Male and Female) will be considered. |
|
| ExclusionCriteria |
| Details |
Patients with other systemic illness or serious pathological conditions.
Patients above 20 years and below 13 years of age.
Patients taking other therapeutic measures or those having any other diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study Utility of The Complete Repertory in Management of Acne in Teen Age. |
follow up every 15 days up to 4 to 6 follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Significant Improvement: Sense of well being with no complains of relapse of the
symtoms.
2. Moderate Improvement: Patient relieved from presenting complaint in frequency
and intensity
3. Status Quo: When there is neither increase nor decrease in the intensity of the
symtoms
|
follow up every 15 days up to 4 to 6 follow up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="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
|
AIM
To Study Utility of the Complete Repertory in Management of Acne in Teen Age, and
Preparation of an easy tool like Repertory & Visual Therapeutics for the same for showing
efficacy of homeopathy in dealing with the aforesaid issue. Sample Size: 40 cases ï‚· Selection of Cases: Randomly select cases based on the criteria set by "Sainath
Homoeopathic Hospital" affiliated with Rajkot Homoeopathic Medical College. ï‚· Statistical Methods: In the forthcoming analysis, we will employ a comprehensive
approach to scrutinize the data, utilizing a range of statistical tools such as frequency
tables, percentages, diagrams, and graphs. This extensive examination will not only
involve the presentation of descriptive statistics but will also encompass the
illustration of results through various visual representations.
CRITERIA FOR WITHDRAWAL AND DROP-OUT
Withdrawal Criteria:
ï‚· Withdrawal is also considered if the disease worsens despite treatment.
Drop-Out Criteria:
ï‚· Cases with no follow-ups are considered for drop-out.
ï‚· Cases with inadequate follow-ups (less than 3 irregular follow-ups) are also eligible
for drop-out.
INTERVENTION GUIDELINES
ï‚· Individualized Homoeopathic Medicine selection is based on the Totality of
Symptoms for each case as their similimum.
ï‚· Potency, dose, and repetition are determined by the patient’s susceptibility. CASE-TAKING PROCEDURE
Guidelines for case taking, as outlined by Dr. Hahnemann in aphorisms §83-§104, are
adhered to when using the Case Performa at Sainath Homoeopathic Hospital
RECORDS
All the records will be maintained as per standard procedure of institution.
RESPONSE WILL BE ANALYSED IN FOLLOWING WAY 1. Significant Improvement: Sense of well being with no complains of relapse of the
symtoms. 2. Moderate Improvement: Patient relieved from presenting complaint in frequency
and intensity 3. Status Quo: When there is neither increase nor decrease in the intensity of the
symtoms
HYPOTHESIS ï‚· Null Hypothesis (H0):
There is no significant difference in the treatment outcomes for ACNE individuals
receiving homoeopathic intervention. ï‚· Alternative Hypothesis (H1):
There is a significant difference in the treatment outcomes for ACNE individuals
receiving homoeopathic intervention.
|