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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
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