| CTRI Number |
CTRI/2023/04/051281 [Registered on: 04/04/2023] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY THE EFFECTIVENESS OF HOMOEOPATHIC MEDICINES IN ACNE VULGARIS |
|
Scientific Title of Study
|
A PROSPECTIVE COMARATIVE STUDY TO EVALUATE THE EFFICAY OF HOMOEOPATHIC MEDICINES- ASTERIA RUBENS,EUGENIA JAMBOS,KALI BROMATUM IN ACNE VULGARIS USING ACNE-QOL QUESTIONNAIRE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR FREEDA M JOSEPH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
NH 47
SANKARI
MAIN ROAD
SEERAGAPADI
SALEM
PIN 636308
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
NH 47
SANKARI
MAIN ROAD
SEERAGAPADI
SALEM
PIN 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9497477956 |
| Fax |
|
| Email |
freedajose92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR FREEDA M JOSEPH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
NH 47
SANKARI
MAIN ROAD
SEERAGAPADI
SALEM
PIN 636308
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
NH 47
SANKARI
MAIN ROAD
SEERAGAPADI
SALEM
PIN 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9497477956 |
| Fax |
|
| Email |
freedajose92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR FREEDA M JOSEPH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
NH 47
SANKARI
MAIN ROAD
SEERAGAPADI
SALEM
PIN 636308
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
NH 47
SANKARI
MAIN ROAD
SEERAGAPADI
SALEM
PIN 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9497477956 |
| Fax |
|
| Email |
freedajose92@gmail.com |
|
|
Source of Monetary or Material Support
|
| VINAYAKA MISSION RESEARCH FOUNDATION DEEMED TO BE UNIVERSITY
SANKARI MAIN ROAD
ARIYANOOR
SALEM
636308
|
|
|
Primary Sponsor
|
| Name |
VINAYAKA MISSION RESEARCH FOUNDATION DEEMED TO BE UNIVERSITY |
| Address |
VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
NH 47
CHINNASEERAGAPADI
SALEM
636308
SANKARI MAIN ROAD
SEERAGAPADI
SALEM
PIN 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 FREEDA M JOSEPH |
Vinayaka Mission Homoeopathic Medical college and Hospital |
Psychiatry OPD
Ground floor
hospital block
Vinayaka Mission Homoeopathic Medical College and Hospital
NH-47,
Sankari Main Road
Seeragapadi
Salem
PIN 636308
Salem
TAMIL NADU |
9497477956
freedajose92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL SALEM |
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 |
Asteria rubens 30 |
4 Pills (30 SIZE) per oral route daily 3 doses for 30 days. |
| Intervention |
Eugenia jambos 30 |
4 pills (30 size) Per oral route daily 3 doses for 30 days. |
| Comparator Agent |
Kali bromatum 30 |
4 pills (30 size) per oral route daily 3 doses for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 BOTH MALES AND FEMALES WITH ACNE VULGARIS WILL BE INCLUDED ACCORDING TO LEEDS CLASSIFICATION OF ACNE VULGARIS REVISED BY CUNLIFFE 2003
2 ADOLESCENCE AND ADULT GROUP WILL BE SELECTED.
3 PATIENTS WITH THE AGE GROUP OF 14-45 YEARS WILL BE SELECTED.
4 DISEASES WITH HORMONAL IMBALANCES AND PREGNANCY WILL BE INCLUDED IN THE STUDY. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO UNDERSTAND THE EFFECTIVENESS OF HOMOEOPATHIC DRUGS IN TREATING ACNE VULGARIS |
AT BASELINE AND EVERY THREE MONTHS UP TO NINE MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE SEVERITY OF ACNE VULGARIS BY LEEDS CLASSIFICATION OF ACNE VULGARIS REVISED BY CUNLIFFE 2003 |
AT BASELINE AND EVERY THREE MONTHS UP TO NINE MONTHS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/04/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous units.it is believed to be the most common disease of the skin.It develops earlier in females than in males.Severity of the disease varies markedly from one individual to another.Grading systems based on the clinical appearance of lesions as well as lesion counting are useful in assessing the severity of the acne vulgaris. |