| CTRI Number |
CTRI/2024/07/071720 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy for Contact Dermatitis |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicine In The Treatment Of Contact Dermatitis Using Eczema Area And Severity Index :A Single Blind Randomized Placebo Controlled Trial |
| 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 GAYATRIBEN BALUBHAI CHAUHAN |
| Designation |
BHMS MD SCHOLAR |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
DEPT. OF ORGANON OF MEDICINE,JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE,PARUL UNIVERSITY,LIMDA,WAGHODIA
Vadodara
GUJARAT
391760
India |
| Phone |
09537478541 |
| Fax |
|
| Email |
gayuchauhan1703@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARTHA SARATHI MANDAL |
| Designation |
PROFESSOR,ORGANON OF MEDICINE |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
DEPT. OF ORGANON OF MEDICINE,
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE ,PARUL UNIVERSITY,LIMDA,WAGHODIA
Vadodara
GUJARAT
391760
India |
| Phone |
09375095471 |
| Fax |
|
| Email |
partha.mandal27317@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PARTHA SARATHI MANDAL |
| Designation |
PROFESSOR,ORGANON OF MEDICINE |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
DEPT. OF ORGANON OF MEDICINE,
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE,PARUL UNIVERSITY,LIMDA,WAGHODIA
Vadodara
GUJARAT
391760
India |
| Phone |
09375095471 |
| Fax |
|
| Email |
partha.mandal27317@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,PARUL UNIVERSITY,LIMDA,WAGHODIA,
VADODARA,GUJARAT,391760 |
|
|
Primary Sponsor
|
| Name |
DR GAYATRIBEN BALUBHAI CHAUHAN |
| Address |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,PARUL UNIVERSITY,LIMDA,WAGHODIA,VADODARA,GUJARAT,391760 |
| Type of Sponsor |
Other [SELF] |
|
|
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 GAYATRIBEN BALUBHAI CHAUHAN |
JAWAHARLAL NEHRU HOMOEOPATHIC HOSPITAL |
DEPT.OF MEDICINE ROOM NO.110,JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE,PARUL UNIVERSITY,LIMDA,WAGHODIA
Vadodara
GUJARAT |
09537478541
gayuchauhan1703@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L259||Unspecified contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PLACEBO |
placebo group patients will receive identical placebo(globules moistened with dispensing alcohol)as an add on to standard protocol treatment. Dose repetition will be a similar pattern to medicinal group. |
| Intervention |
Sulphur,Graphites,Psorinum,Petroleum,Natrum Muriaticum,Arsenicum Album,Mezereum,Alumina,Rhus toxicodendron,Vinca Minor etc. |
Individualized Homoeopathic Medicines like Sulphur, Graphites, Psorinum,Petroleum,Natrum Muriaticum, Arsenicum Album, Mezereum, Alumina, Rhus toxicodendron, Vinca Minor, etc. are prescribed to individuals having contact dermatitis on the basis of strict homoeopathic principles. Administration of the medicine will follow a sublingual route. A suitable potencyÂ
(30/200/1M, etc.) will be prescribed as per the necessity of the case. Repetition of the dose of homoeopathic medicine will be done as per the requirements of the case. The dose will be administered and evaluated until the disappearance of the symptoms of contact dermatitis. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Pre-diagnosed cases of Contact Dermatitis.
2.All Socio-economic status.
3.Subjects who give informed consent to participate in study.
4.Cases which have EASI SCORE less then 51 of contact dermatitis |
|
| ExclusionCriteria |
| Details |
1.Patient having severe, non treatable complication of Contact Dermatitis.
2.Advanced and irreversible pathological cases which require immediate medical attention.
3.Cases which have EASI SCORE more than 51 very severe disease contact dermatitis
4.Patients taking other modes of treatment for contact dermatitis.
5.Contact Dermatitis in pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Homoeopathic Medicines are effective in Contact Dermatitis.
2.Reduction in symptoms of Contact Dermatitis. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the outcome in homoeopathic medicinal group & placebo group by analyzing the improvement in the Contact Dermatitis With The Help Of ECZEMA AREA AND SEVERITY INDEX.
2.To assess the severity of patients before & after treatment in cases of Contact Dermatitis Using ECZEMA AREA AND SEVERITY INDEX. |
3 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2024 |
| 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)
|
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
|
The study is a randomized ,single blind ,parallel group ,placebo controlled trial comparing individualized homoeopathic medicine group for patients with contact dermatitis . the primary outcome is difference in outcome between homoeopathy group and placebo group in cases of contact dermatitis .to assess the severity of patients before and after treatment in cases of contact dermatitis using eczema area and severity index .
|