| CTRI Number |
CTRI/2020/10/028751 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
23/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of the Homoeopathic Medicine Simarouba glauca in the treatment of Rheumatoid Arthritis |
|
Scientific Title of Study
|
Single Blind Randomized Experimental Study to Assess the Efficacy of Simarouba glauca 6C, 12C and 30C 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 H Venkatesan |
| Designation |
Research Coordinator & Associate Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Dept of Practice of Medicine, Second Floor, PG Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Venkatesan |
| Designation |
Research Coordinator & Associate Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Dept of Practice of Medicine, Second Floor, PG Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO, Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Venkatesan |
| Designation |
Research Coordinator & Associate Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Dept of Practice of Medicine, Second Floor, PG Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO, Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari main Road,
Seeragapadi PO, Salem, Tamilnadu - 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH47, Sankari main Road, Seeragapadi PO, Salem, Tamilnadu - 636308 |
| 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 H Venkatesan |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No : 5 B - Dept of
Practice of Medicine,2nd Floor, PG Block, Vinayaka Missions
Homoeopathic Medical
College and Hospital,
NH47, Sankari main
Road, Seeragapadi PO,
Salem, Tamilnadu -
636308
Salem
TAMIL NADU
Salem
TAMIL NADU |
9865134561
venkathompath@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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Simarouba glauca 12C |
5 Medicated Globules of 30 Size will be prescribed orally in morning & night every day before food to each patient for Minimum 90 days duration. |
| Intervention |
Simarouba glauca 30C |
5 Medicated Globules of 30 Size will be prescribed orally in morning & night every day before food to each patient for Minimum 90 days duration. |
| Intervention |
Simarouba glauca 6C |
5 Medicated Globules of 30 Size will be prescribed orally in morning & night every day before food to each patient for Minimum 90 days duration. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Clinically Diagnosed 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
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Serum Rheumatoid Factor and Erythrocyte Sedimentation Rate levels of each Patient after the completion of treatment |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the ‘Rheumatoid Arthritis Impact of Disease (RAID) Questionnaire Score’ |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2020 |
| 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="8"
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 (RA) is
the most common inflammatory arthritis and autoimmune disease that is
associated with progressive disability, systemic complications, early death and
socioeconomic costs.[1]
RA occurs in 0.5-1.0% of the adult population worldwide
and is more common in women.[2,3] Its 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.[3,4]
Complex aetiological factors like genotype(50%),
environment, age, gender, family history, smoking, etc., can cause RA. These triggers
entail several inflammatory cascades leading to persistent synovial inflammation
and associated damage to articular cartilages.[5] About
80% of RA patients are Seropositive for Rheumatoid Factor (Normal range: 0-20 U/ml)
and its presence predicts a more aggressive & destructive course.[6]
Patients often complain of pain & early morning joint
stiffness lasting >1 hour. Typically the small joints of hands and feet are affected
with a polyarticular (>5 joints) symmetric distribution. Later it may affect
the large joints.[7]
The confirmative diagnosis may be done with ‘2010
American College of Rheumatology / European League against Rheumatism
Classification Criteria for RA’.[8]
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.
Simarouba galuca (Lakshmi Taru) is a herb well
known for its medicinal uses including Rheumatoid Arthritis.[10,11] Recent
In-vitro studies have evidenced the anti-inflammatory activity of its extracts
in Arthritis Models.[12,13] But no evidence is available for its
Human Use. This information intended me to do a Comparative Experimental Study
of this medicine in different Homoeopathic potencies, to check its
Effectiveness and Anti-inflammatory property in RA patients. Bibliography:
1.
McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. New
England Journal of Medicine. 2011-Dec 8;365(23):2205-19.
2.
Smolen JS, Aletaha D, et.al. Rheumatoid arthritis. Lancet[Internet].
2016; 388 (10055):2023-2038.
3.
Handa R, et.al. Literature review of rheumatoid arthritis in
India. International journal of rheumatic diseases. 2016-May;19(5):440-51.
4. Carmona L, et.al.
(2010). Rheumatoid arthritis. Best Practice & Research Clinical
Rheumatology, 24(6):733-45.
5.
Scott DL, et.al. (2010). Rheumatoid arthritis. The Lancet,
376(9746):1094-1108.
6.
Firestein GS. Evolving concepts of rheumatoid arthritis. Nature.
2003-May;423(6937):356-61.
7.
Ankoor S. et.al. Rheumatoid Arthritis. Harrison’s Principles of
Internal Medicine. 19th Edition. McGraw Hill. 2015:2136-37.
8.
Aletaha D, et al. 2010 Rheumatoid arthritis classification
criteria: American College of Rheumatology/European League Against Rheumatism
collaborative initiative. Arthritis & rheumatism. 2010-Sep;62(9):
2569-81.
9.
https://www.medassignments.com/rheumatoid-arthritis-7111 (Last accesses 20.07.2020)
10.
Sharanya VK, et.al. A pharmacological review on simarouba glauca.
Int.J.Pharma.Res.Rev. 2016-Jun;5:32-6.
11. Bhattacharyya RK, Debbarma N, et.al. Medicinal plants-Simarouba glauca and Dillenia
indica. Int.J. Minor Fruits, Medicinal and Aromatic Plants.
2018;4(2):42-5.
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