| CTRI Number |
CTRI/2022/01/039550 [Registered on: 19/01/2022] Trial Registered Prospectively |
| Last Modified On: |
18/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of Homoeopathic medicines in the treatment of Facial Pimples. |
|
Scientific Title of Study
|
Clinical study to access the effectiveness of the constitutional Homoeopathic Medicines in the management of Acne Vulgaris. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Dixit |
| Designation |
Post Graduate Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO,
Salem
TAMIL NADU
636308
India |
| Phone |
7350184439 |
| Fax |
|
| Email |
dixitaparna1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Venkatesan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO,
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Venkatesan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO,
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari main Road,
Seeragapadi PO, Salem, Tamilnadu - 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH47, Sankari main Road,
Seeragapadi PO, Salem, Tamilnadu - 636308 |
| 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 H Venkatesan |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No : 3 D - PG Dept of
Practice of
Medicine OPD Unit, Ground Floor, Hospital Block, Vinayaka
Missions Homoeopathic
Medical College and
Hospital, NH47, Sankari
main Road,
Seeragapadi PO,
Salem, Tamilnadu -
636308
Salem
TAMIL NADU |
9865134561
venkathompath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, (2) ICD-10 Condition: L703||Acne tropica, (3) ICD-10 Condition: L708||Other acne, (4) ICD-10 Condition: L709||Acne, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic Medicine |
Suitable Homoeopathic Medicines will be selected according to the Homoeopathic Principles of Symptom Similarity and Guiding symptoms and will be Prescribed to the patient. The medicines will be Prescribed in 30 and 200 Centesimal Potency. 5 Medicated globules of 30 size will be prescribed orally to the patients in Morning before food. Treatment will be given for minimum 3 Months according to the Health Status of the Patients. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical manifestations of Acne Vulgaris
Patients those who have given their consent for study |
|
| ExclusionCriteria |
| Details |
Patients who require surgical involvement for treatment
Patients with major complications or with involvement of systemic illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic Improvement and Improvement in Global Acne Grading System Scores |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
03/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
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 Chronic Inflammation of Pilosebaceous units. It is Eighth most common disease prevailing and mostly 80% - 90% of teenagers or young adolescents are affected as during Puberty secretion of Androgen hormone is more. Although being more prevalent in young age group it can occur in an individual at any age and in both sex. Not a life threatening, but leads to scaring so calls for proper treatment. In this scenario I took up the topic to study the effectiveness of constitutional homoeopathic medicine in treatment of Acne Vulgaris. |