| CTRI Number |
CTRI/2025/03/081835 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How well do homoeopathic medicines work for treating dermatitis |
|
Scientific Title of Study
|
A clinical study to assess the effectiveness of homoeopathic medicines in the cases of dermatitis using DLQI & EASI scale |
| 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 Sanskriti Mishra |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Organon of Medicine 10 11 and 12 Ward No 36 Dr M P K Homoeopathic Medical College Hospital and Research Centre A constituent college of Homoeopathy University Saipura Sanganer
Jaipur
RAJASTHAN
302029
India |
| Phone |
8239121798 |
| Fax |
|
| Email |
dr.sanskritim2711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shri Mohan Sharma |
| Designation |
Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
10 11 and 12 Ward No 36 Dr M P K Homoeopathic Medical College Hospital and Research Centre A constituent college of Homoeopathy University Saipura Sanganer
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829152756 |
| Fax |
|
| Email |
dr.shrimohansharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanskriti Mishra |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Organon of Medicine 10 11 and 12 Ward No 36 Dr M P K Homoeopathic Medical College Hospital and Research Centre A constituent college of Homoeopathy University Saipura Sanganer
Jaipur
RAJASTHAN
302029
India |
| Phone |
8239121798 |
| Fax |
|
| Email |
dr.sanskritim2711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital of Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
DR M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
10 11 And 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| 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 Sanskriti Mishra |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department Of
Organon Of Medicine
Opd Room No 2 Dr M P
K Homoeopathic
Medical College
Hospital And Research
Centre A Constituent
College Of
Homoeopathy
University 10 11 12
Ward No 36 Saipura
Sanganer Jaipur
Rajasthan 302029
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8239121798
dr.sanskritim2711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L20-L30||Dermatitis and eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine
Selected On The Basis Of
Totality Of Symptoms
|
Homoeopathic Medicines Shall
Be Given Orally In Centesimal
Potency As Per Case And
Hahnemannian Guidelines
Given In The 5th Edition Of
Organon Of Medicine In The
Form Of Globule No 40 Dose
And Repetition As Per Need Of Case and reassessment at the end of 3 month
|
| Comparator Agent |
Not applicable since single arm study |
Not applicable since single arm study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving voluntary consent for the study Patients diagnosed with various forms of dermatitis
Patients with a history of dermatitis for at least 3 months |
|
| ExclusionCriteria |
| Details |
Patients with severe systemic illnesses or other skin conditions that could interfere with the study eg psoriasis
Patients currently on systemic immunosuppressive therapy or other treatments that could interfere with the study
Pregnant or breastfeeding women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
According to the score obtained (pre and post treatment) from the DLQI and EASI scale
Spotting the direction of Hering law of cure
Noticing pre dominant miasm in cases of dermatitis
|
Pre score will be taken at baseline of treatment and post score will assessed at the end of the study that is 12 weeks using the DLQI and EASI scale
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study is expected to show effectiveness of homoeopathic medicines selected on the basis of totality of symptoms in cases of dermatitis |
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/03/2025 |
| 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 Yet Recruiting |
| 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
|
AIM To Assess the Effectiveness of Homoeopathic Medicines in the Cases of Dermatitis. OBJECTIVES 1)To evaluate the impact of homeopathic treatment on the quality of life of patients suffering with dermatitis, as measured by the DLQI (Dermatology Life Quality Index) scale, before and after treatment. 2)To evaluate the efficacy of homoeopathic treatment in reducing the severity of dermatitis symptoms as measured by the EASI (Eczema Area And Severity Index) scale, before and after treatment. 3)To analyse the treatment according to Hering’s Law of Cure, in cases of dermatitis using HELAT (Hering’s law assessment tool). 4)To assess the Pre - dominant miasm in the cases of Dermatitis. |