| CTRI Number |
CTRI/2023/06/053615 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The efficacy of Individualized Homoeopathic medicine in case of eczema |
|
Scientific Title of Study
|
To evaluate the efficacy of Individualized Homoeopathic medicine in case of eczema |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravin kumar singh |
| Designation |
Assistant professor Dept of Materia Medica |
| Affiliation |
RBTS govt homeopathic medical college and hospital |
| Address |
RBTS Govt Homeopathic medical college muzaffarpur
Ram dayalu road
Bihar Muzaffarpur BIHAR 842002 India |
| Phone |
9430001076 |
| Fax |
|
| Email |
drpravinsingh83@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pravin kumar singh |
| Designation |
Assistant professor Dept of Materia Medica |
| Affiliation |
RBTS govt homeopathic medical college and hospital |
| Address |
RBTS Govt Homeopathic medical college muzaffarpur
Ram dayalu road
Bihar
Muzaffarpur BIHAR 842002 India |
| Phone |
9430001076 |
| Fax |
|
| Email |
drpravinsingh83@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pravin kumar singh |
| Designation |
Assistant professor Dept of Materia Medica |
| Affiliation |
RBTS govt homeopathic medical college and hospital |
| Address |
RBTS Govt Homeopathic medical college and hospital muzaffarpur
Bihar 842002
near Ramdayalu nagar station muzaffarpur Bihar
Muzaffarpur BIHAR 842002 India |
| Phone |
9430001076 |
| Fax |
|
| Email |
drpravinsingh83@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS GOVT HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL MUZAFFARPUR |
|
|
Primary Sponsor
|
| Name |
RBTS GOVT HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL MUZAFFARPUR |
| Address |
Near Ramdayalu nagar station
muzaffarpur bihar
842002 |
| Type of Sponsor |
Government 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 Pravin Kumar Singh |
OPD of Dept of Dermatology of RBTS Govt Homoeopathic Medical College and Hospital |
Near Ramdayalu Nagar station PO Ramna Muzaffarpur Bihar 842002 Muzaffarpur BIHAR |
9430001076
drpravinkumarsingh83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patient of both the sexes
patient presenting with the symptoms of eczema
is group between 20-50years of age
having written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
case with gross pathological evidences
patients having diabetes hypertension cardiovascular diseases
psychiatric patient
patients required emergency medical intervention patience
pregnant women and lactating |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of the patient |
0 to 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
All the outcome will
be assessed by Atopic Dermatitis Severity Index (ADSI) at baseline (0 month) and after 3 months. |
0 to 3 month |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/06/2023 |
| Date of Study Completion (India) |
30/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Eczema is a chronic, complex, often relapsing inflammatory skin disease. Eczema derives from Greek Word ‘to boil’ which means tiny vesicles. The clinical presentation of eczema includes pruritus, xerosis, and eczematous lesions, and its pathology is characterized by interactions between skin barrier defects and immune dysregulation. There is a consistent association of eczema with other atopic and allergic conditions including asthma and atopic rhinitis. Primary lesions of eczema may include papules, erythematous macules, and vesicles which can coalesce to form patches and plaques. In severe eczema, secondary lesions from infection or excoriation, marked by weeping and crusting, may predominate. Long-standing dermatitis is dry and is characterized by thickened, scaling skin (Lichenification) Eczema is most commonly seen in infancy, with female predominance of eczema presentation occurring during the reproductive period of 15-49yrs.In the overall population, the 12-month adult prevalence of eczema was 4.4% in the EU with individual country ranges of 2.2%. Prevalence rates were higher among females than among males. With the help of homoeopathy, we will evaluate the effect of skin disease only various organ like lungs, liver, renal etc. Allopathic medicine should destroy the local symptom by the tropical application of external remedies, under the belief that he cures the whole disease, where nature makes up for its loss by rousing the internal malady and other symptoms that previously existed in a latent state side by side with the local affection. |