| CTRI Number |
CTRI/2024/04/065968 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of L.M potency in treatment of Atopic Dermatitis. |
|
Scientific Title of Study
|
Usefulness of fifty millesimal potency in management of Atopic Dermatitis in young adults: An exploratory 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 |
Manisha Kumari |
| Designation |
P.G Scholar |
| Affiliation |
Bakson Homeopathic Medical College And Hospital |
| Address |
Room No. F14 1st floor Department of Homeopathic Pharmacy Knowledge Park 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9097866786 |
| Fax |
|
| Email |
manisharauniyar121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manisha Kumari |
| Designation |
P.G Scholar |
| Affiliation |
Bakson Homeopathic Medical College And Hospital |
| Address |
Room No. F14 1st floor Department of Homeopathic Pharmacy Knowledge Park 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9097866786 |
| Fax |
|
| Email |
manisharauniyar121@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CP Sharma |
| Designation |
Professor & HOD of Department of Homeopathic Pharmacy |
| Affiliation |
Bakson Homeopathic Medical College And Hospital |
| Address |
Room No. G22 Ground floor Principal Office Bakson Homeopathic Medical College And Hospital Knowledge Park 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9899101747 |
| Fax |
|
| Email |
principal@bakson.net |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic medical college and hospital |
| Address |
Room No G22
Ground Floor
Principal Office
Bakson Homeopathic Medical College And Hospital Knowledge Park 1 Greater Noida |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manisha Kumari |
Bakson Homeopathic Medical College And Hospital Knowledge Park 1 Greater Noida 201310 |
Out Patient Department (OPD) Room No 1 Ground Floor Bakson Homeopathic Medical College And Hospital Knowledge Park 1 Greater Noida 201310
Gautam Buddha Nagar
UTTAR PRADESH |
9097866786
manisharauniyar121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bakson Homeopathic Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homeopathic Medicine |
Oral root of administration Medicine used in liquid form L.M potency first dose is given after taking the case Subsequent doses after each followup Potency according to the case
15 months duration of study
6months enrollment 6 months treatment and followup
3 months for data analysis |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Age group from 15 to 24 years for both genders
Diagnosed patients by Hanifin and Rajka criteria
History of recurrence of disease in past 5 years
|
|
| ExclusionCriteria |
| Details |
Any other dermatological condition associated with Atopic Dermatitis
Any bacterial or viral infections
Patients with psychiatric diseases
Patient who are not able to comply to the study protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected to have positive changes on EASI Scale. |
EASI scale will be performed at 4th 8th 12th upto 24th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
10/05/2024 |
| 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="3"
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 to assess the role of homeopathic medicine in L.M potency to the treatment of Atopic Dermatitis Sample size is 31 Single Arm Study 15 month study Screening by hanifin and rajka criteria Scale used for treatment is DLQI and EASI It is expected to see the positive changes in these scales |