| CTRI Number |
CTRI/2024/05/067867 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of BBCR Homoeopathic Repertory in treatment of Eczema |
|
Scientific Title of Study
|
A clinical study on the utility of BBCR in cases of Eczema- A Prospective observational Study |
| 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 Pranjal kumar |
| Designation |
PG Scholar |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital Muzaffarpur, Bihar |
| Address |
OPD- 1-6 and PG Building
R.B.T.S. Govt. Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar.
Muzaffarpur
BIHAR
842002
India |
| Phone |
919450289657 |
| Fax |
|
| Email |
pranjalkumar0803@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit |
| Designation |
HOD, Dept. of Homoeopathic Repertory and Case taking |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital |
| Address |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar.
Muzaffarpur
BIHAR
842002
India |
| Phone |
7765802619 |
| Fax |
|
| Email |
amitrisdth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit |
| Designation |
HOD, Dept. of Homoeopathic Repertory and Case taking |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital |
| Address |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar.
Muzaffarpur
BIHAR
842002
India |
| Phone |
7765802619 |
| Fax |
|
| Email |
amitrisdth@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.B.T.S. Govt. Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital |
| Address |
Ramdayalu Nagar, 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 Pranjal Kumar |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar, 842002 |
OPD-1,5,6 in Hospital Building
Muzaffarpur
BIHAR |
919450289657
pranjalkumar0803@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RBTS Govt. Homoeopathic Medical College and Hospital- IEC |
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 |
Constitutional Homoeopathic Medicine |
BBCR Homoeopathic Repertory is consulted for repertorozation and medicine will be prescribed. Potency will be used from 6C ,30C,200C,1M. Medicine will be administrated by oral route. Follow up done in every 15 days. Study will be minimum 3 month for each subject |
| Comparator Agent |
NIL |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 30-50 will be included.
Both male and female patients will be included.
Only clinically diagnosed patients as per signs/symptoms of eczema will be included. |
|
| ExclusionCriteria |
| Details |
Patients taking allopathic treatment will be excluded.
Patients using any kind of medicinal ointments, steroidal creams, lotions will be excluded.
Pregnant women will be excluded.
Lactating women will be excluded.
Patient having a history of surgery will be excluded.
Patients taking any Ayurvedic treatment will be excluded.
Patients having addiction to tobacco, alcohol, smoking will be excluded.
Patients having any other co-morbidities like Diabetes, Hypertension, Cardiac diseases, Cancer will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected from the study that it will increase the scope of BBCR in selecting homoeopathic medicines in treatment of skin diseases especially eczema and will provide a good alternative to the conventional mode of treatment with no side effects. It will also bring statistically more significant changes in the POEM scale. |
3-4 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out group of homoeopathic medicines effective in managing the cases of eczema and
To see the changes in Patient-Oriented Eczema Measure (POEM scale) in eczema. |
3-4 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| 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="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
|
In Cases of Eczema, using the BBCR Repertory can aid Homoeopaths in identifying potential remedies based on individual symptoms presented by the patients. |