CTRI Number |
CTRI/2021/10/037553 [Registered on: 25/10/2021] Trial Registered Prospectively |
Last Modified On: |
25/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Siddha |
Study Design |
Single Arm Study |
Public Title of Study
|
A Clinical trial to study the effect of the drug Chanthirothaya Mathirai in management of patients having Rheumatoid Arthritis(Uthiravatha Suronitham) |
Scientific Title of Study
|
Phase II Non-Randomized Open Clinical Evaluation of Siddha Medicine Chanthirothaya Mathirai for the management of Uthiravatha Suronitham (Rheumatoid Arthritis) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sudhaadevi PV |
Designation |
PG Scholar |
Affiliation |
Government Siddha Medical College |
Address |
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
9698999897 |
Fax |
|
Email |
suhaashini65@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Chitra SM |
Designation |
Lecturer |
Affiliation |
Government Siddha Medical College |
Address |
Department of General Medicine Government Siddha Medical College Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
9444177230 |
Fax |
|
Email |
chittu758@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sudhaadevi PV |
Designation |
PG Scholar |
Affiliation |
Government Siddha Medical College |
Address |
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
944251397 |
Fax |
|
Email |
suhaashini65@gmail.com |
|
Source of Monetary or Material Support
|
Government Siddha Medical College 6 Anna Arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu |
|
Primary Sponsor
|
Name |
Government Siddha Medical College |
Address |
Post graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamilnadu |
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 Sudhaadevi PV |
Aringnar Anna Government Hospital of Indian Medicine |
Room no S1 Siddha Department 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 Chennai TAMIL NADU |
9698999897
suhaashini65@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: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
CHANTHIROTHAYA MATHIRAI |
360 mg of Chanthirothaya Mathirai is administered twice a day with Indhuppu legiyam for 48 days |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
Age limit of 20-55 years
Anti Cyclic Citrullinated Peptide(AntiCCP)-5ml or more and RA positive
H/O Morning stiffness for more than 1 hour
Multiple joint involvement
Symmetreical Arthritis
Rheumatoid Nodules
|
|
ExclusionCriteria |
Details |
H/O Rheumatic fever
H/O Psoriatic Arthropathy
H/O Reiters Arthritis
H/O Systemic Lupus Erythematous
H/O Sjogrens syndrome
H/O Progressive Systemic Sclerosis
H/O Any other serious systemic Illness
Pregnant women, Lactating Mothers |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Primary outcome is mainly assessed by reduction in clinical symptoms measured by Universal pain Assessment Scale(Visual Analogue Scale) |
48 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Secondary Outcome is assessed by comparing the safety parameters before and after treatment |
48 days |
|
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 2 |
Date of First Enrollment (India)
|
25/10/2021 |
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
|
Not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This is a Single Non randomised open clinical trial to study the safety and efficacy of Siddha trial Drug Chanthirothaya Mathirai. The trial drug is given 360mg of tablet twice a day for 48 days. Clinical trial is conducted after conducting Pre clinical toxicity study. The trial drug Chanthirothaya mathirai is mentioned in Anuboga Vaithiya Sigamani. During this trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically |