| CTRI Number |
CTRI/2022/05/042720 [Registered on: 23/05/2022] Trial Registered Prospectively |
| Last Modified On: |
20/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Homoeopathic Medicine and Kali Bromatum in treatment of Acne vulgaris. |
|
Scientific Title of Study
|
Usefulness of Individualized Homoeopathic medicine versus Kali Bromatum in treatment of Acne Vulgaris: A Comparative study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalpana Devi Rajput |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room number 311
Floor number 3
Department of Paediatrics
Bakson Homoeopathic Medical College and Hospital
36B Knowledge park 1 Phase 1
Greater Noida
Distt Gautam Buddha Nagar
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8115257869 |
| Fax |
|
| Email |
kalpanadevirajput534@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Gontiya |
| Designation |
Associate Professor and Guide |
| Affiliation |
Bakson Homoeopathic medical college and Hospital |
| Address |
Room number 311
Floor number 3rd
Department of Paediatrics
Bakson Homoeopathic Medical College and Hospital
36B Knowledge park 1 Phase 1
Greater Noida
Distt Gautam Buddha Nagar
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8115257869 |
| Fax |
|
| Email |
ritugontiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Garg |
| Designation |
Head of Department |
| Affiliation |
Bakson Homeopathic Medical college and Hospital |
| Address |
Room number 311
Floor number 3rd
Department of Paediatrics
Bakson Homoeopathic Medical College and Hospital
36B Knowledge park 1 Phase 1
Greater Noida
Distt Gautam Buddha Nagar
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room number G 22
Ground floor
36B Knowledge Park 1 Phase 1
Greater Noida
Distt Gautam Budhha Ngar |
| 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 |
| Kalpana Devi Rajput |
Bakson Homoeopathic Medical college and Hospital |
Out patient Department
Room number 1
Groud floor
36B Knowladege Park 1 Phase 1
Greater Noida
Distt Gautam Budhha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
8115257869
kalpanadevirajput534@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee Bakson 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 |
Group A Homoeopathic medicine
|
First dose at the start of the treatment.
Globule Form. 30 pill size
Oral route of administration
Follow up at every 15 days
Repetition of dose according to the follow up
|
| Intervention |
Group B Kalium bromatum |
First dose at the start of the treatment
Oral route of administration
Centesimal Scale
Globules form 30 pill size
follow up every 15 days
Repetition of dose according to follow up |
| Comparator Agent |
NIl |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients will be selected between the age group of 12-18 years.
2 Patient showing symptoms of Acne Vulgaris: Open Comedones (Black head), closed comedons (white head), papules and pustules and Nodulocystic acne. |
|
| ExclusionCriteria |
| Details |
1 Patient under any other medication for Acne.
2 Patient suffering from of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in severity of Acne vulgaris using Global Acne Grading System (GAGS) |
12 month study
5 months enrollment
6 month follow up
1 month analysis
GAGS will be used at Baseline, 3 months and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
26/05/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tilte: Usefulness of Individualized Homoeopathic Medicine Versus Kali Bromatum in Treatment of Acne Vulgaris: A Comparative study Aim : To evaluate the usefulness of individualized homoeopathic medicine versus kali bromatum in the treatment of Acne Vulgaris Objective: Primary Objective: To study the usefulness of individualized homoeopathic medicine in comparison with kali bromatum for the treatment of Acne Vulgaris Secondary Objective : To assess the GAGS (GLOBAL ACNE GRADING SYSTEM SCORE) after the treatment with individualized medicine or Kali Bromatum in the Caes of Acne Vulgaris.
Sample size will be 68, distributed in to 2 groups GROUP A INDIVIDUALIZED HOMOEOPATHIC MEDICINE will be prescribed (n=34) GROUP B KALI BROMATUM will be prescribed (n=34) |