| CTRI Number |
CTRI/2025/07/090031 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of rheumatoid arthritis |
|
Scientific Title of Study
|
A clinical study on the efficacy of Homoeopathic constitutional medicine in the management of Rheumatoid Arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suman sinha |
| Designation |
Pg scholar |
| Affiliation |
Rbts govt hom medical college |
| Address |
At-singhia ghat ward number 9,near brahamsthan ,singhia buzurg
At-singhia ghat ward number 9,near brahmasthan ,singhia buzurg
Samastipur
BIHAR
848236
India |
| Phone |
9128085424 |
| Fax |
|
| Email |
sumananjali0734@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vivek kumar shail |
| Designation |
Associate professor |
| Affiliation |
Rbts govt hom medical college |
| Address |
Rbts govt homoeopathic medical college hospital ramdayalu nagar muzaffarpur Bihar 842002
Muzaffarpur
BIHAR
842002
India |
| Phone |
8298994658 |
| Fax |
|
| Email |
drviknih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman sinha |
| Designation |
Pg scholar |
| Affiliation |
Rbts govt hom medical college |
| Address |
Rbts govt homoeopathic medical college and hospital muzaffarpur Bihar 842002
Muzaffarpur
BIHAR
848236
India |
| Phone |
09128085424 |
| Fax |
|
| Email |
sumananjali0734@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rbts govt homoeopathic medical college |
| Address |
Ramdayalu nagar muzaffarpur Bihar India 842002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suman sinha |
Rbts govt homoeopathic medical college and hospital muzaffarpur Bihar |
Ramdayalu nagar muzaffarpur 842002
Muzaffarpur
BIHAR |
09128085424
sumananjali0734@gmail.com |
| Dr suman sinha |
Rbts govt homoeopathic medical college and hospital muzaffarpur Bihar |
opd no 1 opd no 3 opd no 4 opd no 5
Muzaffarpur
BIHAR |
9128085424
sumananjali0734@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RBTSGHMC AND H IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional homoeopathic medicine. |
Medicine will be selected on the basis of totality of symptom and constitution of the patient.Medicine will be administrated by oral route.Potency will be used from 30c,200c,1M.
Follow up done in every 12 to 18 days.Study will be minimum for 3 months.Synthesis repertory is consulted for repertorozation if essential. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
RA factor positive and or anticcp positive
confirmed cases of rheumatoid arthritis
male and female
give consent for participation in study |
|
| ExclusionCriteria |
| Details |
above 50 and below 20 year
Ra negative case
comorbidities condition
the patient not give consent for study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of study there is constant amelioration of problem as per their symptmatology
|
At the end of 3-4 month of study there is constant amelioration of problem as per their symptmatology
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| At the end of study there is constant amelioration of the problem patient becomes healthy and come back in normal condition |
After 6 follow up |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
12/07/2025 |
| 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="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
|
Rheumatoid arthritis primarily affect synovium and adjacent tissues as it is a multisystem inflammatory disease of unknown etiology characterized by a symmetric polyarthritis the most common form of chronic inflammatory arthritis the development and expression of the disease are most importantly determined by immunogenic factors individuals are identified at 13 times greater risk of developing bony erosions at 1 years when conserved amino acid sequence in the third hyper variable region of HLADRB1 COMBINES WITH POSITIVE rheumatoid factor improvement in the cases of rheumatoid arthritis after administration of medicine prescribed based upon the totality of symptom due to medicine effect and evaluate the efficacy of homoeopathic constitutional medicine in curing the cases of rheumatoid arthritis |