| CTRI Number |
CTRI/2024/11/076852 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Preventive
Screening |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Atopic dermatitis is a chronic skin condition sometimes cause asthma. This study examines the effectiveness of carbon group homeopathic remedies, particularly graphites and petroleum. |
|
Scientific Title of Study
|
Effectiveness Of Carbon Group With Special Emphasis On Graphites And Petroleum In Cases Of Atopic Dermatitis Through EASI Score. |
| 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 Uma Kishorbhai Malaviya |
| Designation |
BHMS,PG Scholar |
| Affiliation |
Parul institute of homeopathy and research |
| Address |
101C Medicine OPD,Parul institute of homeopathy and research ,Parul University,Post limda,Waghodia,Vadodra
Vadodara
GUJARAT
391760
India |
| Phone |
9870032076 |
| Fax |
|
| Email |
malaviyauma443@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Tapas |
| Designation |
MD Hom, professor of materia Medica,Pg guide |
| Affiliation |
Parul institute of homeopathy and research |
| Address |
101C , Medicine OPD, Parul institute of homeopathy and research ,Parul University,Post limda,Waghodia,Vadodra
Vadodara
GUJARAT
391760
India |
| Phone |
9870032076 |
| Fax |
|
| Email |
mamta.tapas87086@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uma Kishorbhai Malaviya |
| Designation |
BHMS,PG Scholar |
| Affiliation |
Parul institute of homeopathy and research |
| Address |
101C, medicine OPD ,Parul institute of homeopathy and research ,Parul University,Post limda,Waghodia,Vadodra
Vadodara
GUJARAT
391760
India |
| Phone |
9870032076 |
| Fax |
|
| Email |
malaviyauma443@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of homeopathy and research Hospital ,Parul
University,Post
limda,Waghodia,Vadodra,391760
Gujrat, India. |
|
|
Primary Sponsor
|
| Name |
Dr Uma Kishorbhai Malaviya |
| Address |
Parul institute of homeopathy and research,Parul University,Post limda,Waghodia,Vadodra,391760, Gujarat, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Uma malaviya |
Parul Institute of Homeopathy and Research Hospital |
101C, medicine OPD,Parul Institute of Homeopathy and Research Hospital, Parul University,Vadodara
Vadodara
GUJARAT |
9870032076
malaviyauma443@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PIHR IECHR |
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
|
| Type |
Name |
Details |
| Intervention |
GRAPHITES |
according to remedy similarity i gave medicine and according to susceptibility i will select potency ,30/200/1m, OD/BD/TDS for 7 days |
| Comparator Agent |
PETROLEUM |
according to similarity i will give medicine and i will give potency ,30/200/1m , OD/BD/TDS, FOR 7 days |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Of both sex and all age
1.All socio-economical groups
2.Patient who diagnosed with atopic dermatitis according to clinical sign and symptoms
3.Patient who under mild to modrate atopic dermamatitis according to SCORAD score.
- Patient not on topical/steroidal treatment within last 3 months. |
|
| ExclusionCriteria |
| Details |
1.Patient diagnosed with other skin disorder other than eczema.
2.Patient who have ongoing topical/steroidal treatment. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Graphites and Petroleum in reducing symptoms of Atopic Dermatitis (AD) in patients, as measured by the Eczema Area and Severity Index (EASI) score. |
12 months , follow up every week or 2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical utility of Graphites and Petroleum in cases of atopic dermatitis. |
12 month, 4 month per patient |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/11/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Atopic dermatitis is a chronic inflammatory skin condition marked by intense itching and flare-ups, commonly linked to asthma and allergies. Conventional treatments often do not effectively restore the skin barrier. This study investigates the potential of carbon-based homeopathic remedies, particularly graphites and petroleum, as safer alternatives for managing atopic dermatitis. It utilizes the EASI score to objectively assess the severity and impact of these treatments on the condition. |