| CTRI Number |
CTRI/2024/12/077933 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of Homoeopathy In The Treatment Of Atopic Dermatitis Among Adults |
|
Scientific Title of Study
|
Effect Of Individualized
Homoeopathic Medicine In The Treatment Of Atopic Dermatitis Among Adults : A Prospective Pre And Post Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR UTKARSH ASHISH |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
Basement Floor
Room No B 16
Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7217833299 |
| Fax |
|
| Email |
dr.utkarshashish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANAMIKA BAKSHI |
| Designation |
Guide & Associate Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
OPD No 2
Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8377015300 |
| Fax |
|
| Email |
dr.anamikabakshi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AKSHAY MATHUR |
| Designation |
HOD & Professor Department of Practice Of Medicine |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
Basement Floor
Room No B 16
Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College And Hospital 36 B Knowledge Park 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Bakson Homoeopathic Medical College And Hospital Room No G22 Ground Floor 36B Knowledge Park 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
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 Utkarsh Ashish |
Bakson Homoeopathic Medical College and Hospital |
Outpatient Department (OPD) Room No 1 Ground Floor Bakson Homoeopathic Medical College and Hospital Room No 1 36 B Knowledge Park 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7217833299
dr.utkarshashish@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: L20||Atopic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Homoeopathic Medicine |
Pill form
30 pill size
Oral route of administration
Centesimal scale
First dose at the time of case taking
Subsequent doses according to follow up for a period of 6 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged between 18 and 59 years.
Diagnosed cases of Atopic Dermatitis by Hanifin and Rajka criteria.
Participants already on allopathic medication/topical agents for Atopic Dermatitis will be included after 15 days of washout period.
|
|
| ExclusionCriteria |
| Details |
Participants with other severe dermatological conditions or autoimmune diseases.
Participants suffering from any severe systemic illness , immuno-compromised conditions, severe psychiatric issues.
Pregnant or lactating women.
Participants who are not able to comply to the study protocol.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that there will be improvement in Dermatology Life Quality Index (DLQI) scale indicating better quality of life |
15 month study.
6 months enrolment
6 months follow up
3 months analysis
Dermatology Life Quality Index (DLQI) scale will be assesses at baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that there will be reduction in the Eczema Area and Severity Index score from baseline to the end of the study period |
15 month study.
6 months enrolment
6 months follow up
3 months analysis
Eczema Area and Severity Index (EASI) Scale will be assessed at baseline and after 6 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
20/12/2024 |
| 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 aims to explore the role of individualized homoeopathic medicine in the treatment of Atopic Dermatitis Sample size 35 Prospective pre and post clinical study 15 months study Scale used for assessment are DQLI scale and EASI scale Baseline score and final score at the end of treatment will be used for final assessment It is expected that there will be improvement in Dermatology Life Quality Index (DLQI) scale indicating better quality of life and reduction in Eczema Area and Severity Index (EASI) score |