| CTRI Number |
CTRI/2025/01/079366 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Use Of Homoeopathy in Contact Dermatitis |
|
Scientific Title of Study
|
Role Of Individualized Homoeopathic Medicine In Treatment Of Contact Dermatitis Using Homoeopathic Medical Repertory An Open Label, Prospective Clinical 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 Sengar Chetan Harisingh |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homeopathy |
| Address |
OPD Room No. 10. Department of Repertory,National Institute of Homeopathy
GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 India
Kolkata
WEST BENGAL
700106
India |
| Phone |
8160358427 |
| Fax |
|
| Email |
chetan2031999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binod kumar bhagat |
| Designation |
Proffessor |
| Affiliation |
National Institute of Homeopathy |
| Address |
OPD Room No. 10. Department of Repertory,National Institute of Homeopathy
GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 India
Kolkata
WEST BENGAL
700106
India |
| Phone |
8220003741 |
| Fax |
|
| Email |
dr.binodkbhagat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binod kumar bhagat |
| Designation |
Proffessor |
| Affiliation |
National Institute of Homeopathy |
| Address |
OPD Room No. 10. Department of Repertory,National Institute of Homeopathy
GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 India
Kolkata
WEST BENGAL
700106
India |
| Phone |
8220003741 |
| Fax |
|
| Email |
dr.binodkbhagat@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homeopathy GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 India. |
|
|
Primary Sponsor
|
| Name |
National Institute of Homeopathy |
| Address |
National Institute of Homeopathy GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 India. |
| 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 Sengar Chetan Harisingh |
National Institute of Homeopathy |
OPD No 10, Department of Repertory National Institute of Homeopathy GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 India
Kolkata
WEST BENGAL |
8160358427
chetan2031999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L230||Allergic contact dermatitis due tometals, (2) ICD-10 Condition: L240||Irritant contact dermatitis due todetergents, (3) ICD-10 Condition: L231||Allergic contact dermatitis due toadhesives, (4) ICD-10 Condition: L232||Allergic contact dermatitis due tocosmetics, (5) ICD-10 Condition: L233||Allergic contact dermatitis due todrugs in contact with skin, (6) ICD-10 Condition: L234||Allergic contact dermatitis due todyes, (7) ICD-10 Condition: L235||Allergic contact dermatitis due toother chemical products, (8) ICD-10 Condition: L236||Allergic contact dermatitis due tofood in contact with the skin, (9) ICD-10 Condition: L238||Allergic contact dermatitis due toother agents, (10) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause, (11) ICD-10 Condition: L241||Irritant contact dermatitis due tooils and greases, (12) ICD-10 Condition: L242||Irritant contact dermatitis due tosolvents, (13) ICD-10 Condition: L243||Irritant contact dermatitis due tocosmetics, (14) ICD-10 Condition: L244||Irritant contact dermatitis due todrugs in contact with skin, (15) ICD-10 Condition: L245||Irritant contact dermatitis due toother chemical products, (16) ICD-10 Condition: L246||Irritant contact dermatitis due tofood in contact with skin, (17) ICD-10 Condition: L248||Irritant contact dermatitis due toother agents, (18) ICD-10 Condition: L249||Irritant contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic
medicine |
Indicated individualized
homoeopathic medicine will be
prescribed after the repertorisation of the case using rubrics within Homoeopathic Medical
repertory. Dose and frequency
of the selected medicine will be as per the susceptibility of the case.Follow up will be done monthly till 6 months from the Baselines |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Case Of Chronic Contact Dermatitis in the Age group 18 to 65 years & of Both the sexes.
Literate Patients willing to give written informed consent. Patients who can read or write or understand Hindi English Bengali.
Patients already undergoing regular oral/topical conventional therapy for C.D may be recruited only if the medications are stopped completely 3 months prior to the treatment.
|
|
| ExclusionCriteria |
| Details |
Diagnosed cases of unstable mental or psychiatric illness or uncontrolled or life-threatening illness.
Pediatric age group & Lactating Women.
Substance abuse & or dependence Patient under the treatment of any other therapy.
Patients not willing to participate in the study.
Patients not willing to undergo any investigation, if so advised.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient-Oriented Scoring for Atopic Dermatitis |
Baseline & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Socio-demographic data
Statical analysis
Statistical Inferences |
Baseline & 6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
03/02/2025 |
| 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="6"
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
|
Contact dermatitis (CD) is very common, Chronic
relapsing inflammatory skin diseases that affects all age groups, The quality of life of patients & public
health cost is significantly affected by CD. The two most common types of CD
are allergic & irritant. In Most cases, both types as eczematous lesions on
uncovered part of body, Particularly the hands. 1. Sample will be selected following preliminary & detailed screening using specified selection criteria. 2. Inclusion & exclusion criteria are strictly followed. 3. After consideration of dropout cases a minimum 42 patients will be enrolled for the study. 4. Case taking will be done as per the strict homoeopathic principle. 5. Base line scoring will be taken using POSCORADS. 6. Analysis & evaluation of each case will be done. 7. Miasmatic analysis will be done. 8. Repertorization will be done in Homoeopathic Medical Repertory. 9. Final selection of the remedy will be done after consultation with Materia Medica. 10. Potency,Dose & repetition of the indicated remedies will be guided strictly as per homeopathic principles. 11. General managment including apppropriate diet & regimen will be adivsed. 12. Subsequent prescriptions follow-ups will be generated acccording to relevant homoeopathic principles & will be recorded in follow up sheets. 13. The baseline data will be compared with the data obtained in 6th month. 14. The score obtained by the patients will be compared & result will be analyzed statistical methods & interference will be done thereafter. |