| CTRI Number |
CTRI/2024/06/068342 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
To study the role of homoeopathic medicines in cases of eczema |
|
Scientific Title of Study
|
A clinical study to assess the effectiveness of individualised Homoeopathic medicine in cases of Eczema |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr komalben Dilipsinh Vansadiya |
| Designation |
PG scholar |
| Affiliation |
Rajkot Homoeopathic Medical College Parul University |
| Address |
Department of practice of medicine, rajkot homoeopathic medical college, b/h jainath petrol pump gondal road rajkot 360002
Rajkot GUJARAT 360002 India |
| Phone |
9737461271 |
| Fax |
|
| Email |
komalvansadiya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shailendra Bhamar |
| Designation |
proffesor (practice of medicine) & PG GUIDE |
| Affiliation |
Rajkot Homoeopathic Medical College Parul University |
| Address |
Department of practice of medicine, rajkot homoeopathic medical college, b/h jainath petrol pump gondal road rajkot 360002
Rajkot GUJARAT 360002 India |
| Phone |
9737461271 |
| Fax |
|
| Email |
shailendra.bhamar17970@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr komalben Dilipsinh Vansadiya |
| Designation |
PG scholar |
| Affiliation |
Rajkot Homoeopathic Medical College Parul University |
| Address |
Department of practice of medicine, rajkot homoeopathic medical college, b/h jainath petrol pump gondal road rajkot 360002
Rajkot GUJARAT 360002 India |
| Phone |
9737461271 |
| Fax |
|
| Email |
komalvansadiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College,behind jainath complex makkam chowk gondal road, rajkot 360002,Gujarat India |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College Parul UNiversity |
| Address |
Behind Jainath Complex, makkam chowk, gondal road,Rajkot 360002 , Gujarat,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 Komalben Dilipsinh Vansadiya |
Rajkot Homoeopathic Medical College attached with Sainath Medical College,Parul University |
Behind jainath complex,makkam chowk,gondal road,Rajkot
Department : Practice of Medicine
Division -A
Room Number - 104 Rajkot GUJARAT |
9737461271
Komalvansadiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research - Rajkot Homoeopathic Medical College (RHMC),Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine selected on the basis of totality of symptoms
Doses based on the Susceptibility of the patients in 30,200 or 1M potency.
Route of Administration is orally.
frequency of repeatation depending upon symptoms 7days,15days,1month
total duration upto 3 months
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
I. Samples of both sexes and all ages will be taken.
II. Cases of chronic eczema will be taken.
|
|
| ExclusionCriteria |
| Details |
I. Life-threatening complications are excluded in this study.
II. Patient with immune compromised are excluded in this study.
III. Pregnant and lactating females are excluded in this study.
IV. Patient with other skin diseases with same manifestation are excluded.
v. case with irregular follow up. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess The Effectiveness Of Individualized Homoeopathic Medicine In Case Of Eczema |
12 Weeks, 24 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Check The Patients Response To The Medicine |
12 Weeks, 24 Weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/06/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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
|
NEED FOR STUDY : Eczema is a skin disease which is associated with many cosmetic concern for the person including feeling of embracement and stigmatization as well as challenges to opportunities and interpersonal relationships. Eczema flare up may causes a person to stressed, anxious or depressed. They may also experience fatigue and social withdrawal due to their physical and mental health symptoms. People with eczema may feel depressed, ashamed or hopeless about their situation, which can affect their mental well being and also withdrawal or avoid social activities, physical activities and relationships. Children with eczema feels embraces at school and especially when the affected areas are difficult to cover such as face, scalp, hands. In adults also very difficult situation in the person who is working in good professional job. Natural treatment of eczema currently is of considerable interest among dermatologist. For the holistic natural treatment of eczema classic homoeopathic medicines are useful. The major advantage of homoeopathic medicine in the conventional dermatological practice include low cost, easily availability, easy to administration, patient acceptability and reduction in the topical steroid use. Eczema was estimated to affect 245 million people globally in 2015 or 3.34 percentage population. Atopic eczema is most common type and may generally starts in childhood. Research suggest that homoeopathic treatment for allergies may be ideal because this type of therapy acts as an immunoregulator, immunomodulator, possibly regulating or reviving the immune system. Homoeopathy being one of the most effective line of treatment, it can be helpful in treating eczema but reversal of it is also possible in early stages with proper Homoeopathic medication and lifestyle modification. |