| CTRI Number |
CTRI/2023/01/049330 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Homoeopathic medicine in the treatment of Rheumatoid Arthritis. |
|
Scientific Title of Study
|
Exploratory study to assess the Efficacy of the Homoeopathic Medicines Medorrhinum 1m,Stelleria Media Q and Chininum Sulph 6c in combination in the treatment of Rheumatoid Arthritis patients, |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Janani |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Second floor, UG Department Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari main Road, Seeragapadi Post, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
|
| Fax |
|
| Email |
janudr.homoeo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Janani |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Second floor, UG Department Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari main Road, Seeragapadi Post, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
|
| Fax |
|
| Email |
janudr.homoeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Janani |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Second floor, UG Department Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari main Road, Seeragapadi Post, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
|
| Fax |
|
| Email |
janudr.homoeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari main Road, Seeragapadi Post, Salem Pincode 636308Â |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH47, Sankari main Road, Seeragapadi PO, Salem, Tamilnadu - 636308Â |
| Type of Sponsor |
Private 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 P Janani |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Dept of Practice of Medicine,2nd Floor, UG Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari main Road, Seeragapadi PO, Salem, Tamilnadu - 636308 Salem TAMIL NADU
Salem
TAMIL NADU |
8667601906
janudr.homoeo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M06||Other rheumatoid arthritis, (2) ICD-10 Condition: M05||Rheumatoid arthritis with rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chininum sulph 6c |
4 pills ( 30 size) per oral route every morning daily for 180 days |
| Intervention |
Medorrhinum 1m |
4 pill(30 size) per oral route weekly one dose for 180 days |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Stelleria Media Q |
5 drops in 10 ml of water per oral route morning and night daily for 180 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid arthritis |
|
| ExclusionCriteria |
| Details |
Patients with systemic Complications and deformities.
patients with Extra-articular manifestations.
Patients under Chronic medication for Rheumatoid Arthritis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in ESR,CRP,Anti CCP antibodies and Rheumatoid factor.
reduction in Rheumatoid Arthritis Impact of Disease (RAID)Scores and Visual Analogue Pain Scale.
|
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of life |
180 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/02/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid arthritis is the most common inflammatory arthritis and autoimmune disease that us associated with progressive disability,systemic complications,early death and socioeconomic costs.RA occurs in 0.5-1.0% of the adult population worldwide and is more common in women.In Indian prevalence is ranging between 0.19-2.50%.The peak incidence is between the ages of 20 and 40,the most productive years of adulthood. Patients often complain of pain & early morning joint stiffness lasting> 1 hour.Typically the small joints of hands and feet are affected with a poly articular (>5 joints) symmetric distribution.Later it may affect the large joints.The classical Extra-articular manifestations of RA are also extensive. The confirmatory diagnosis may be done with ’2010 American College of Rheumatology/ European League against Rheumatism Classification Criteria for RA’. RA has a significant negative impact on the ability to perform daily activities,including work & household tasks, and health related quality of life, The goal of treatment in RA patients is to eliminate symptoms,slow disease progression and optimize quality of life. Since the Medicine combination of Medorrhinum 1m,Stelleria Media Q and Chininum Sulph 6c has not yet been clinically tested for its effectiveness in the treatment of Rheumatoid Arthritis,the proposed Research project will be a pioneer Clinical Research outcome if preceded.
|