| CTRI Number |
CTRI/2018/12/016562 [Registered on: 07/12/2018] Trial Registered Prospectively |
| Last Modified On: |
06/12/2018 |
| 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 RASA CHENDURAM IN PATIENTS HAVING RHEUMATOID ARTHRITIS |
|
Scientific Title of Study
|
EVALUATION OF RASA CHENDURAM FOR UTHIRAVAATHA SURONITHAM(RHEUMATOID ARTHRITIS)-AN OPEN CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sabarmathi S |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college |
| Address |
Post Graduate
Department of General medicine
Government Siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8870285172 |
| Fax |
|
| Email |
sabarmathi44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu N |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college |
| Address |
Post Graduate
Department of General medicine
Government Siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabarmathi S |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college |
| Address |
Post Graduate
Department of General medicine
Government Siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8870285172 |
| Fax |
|
| Email |
sabarmathi44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha medical college |
| Address |
Government Siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106 |
| 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 Sabarmathi S |
Arignar Anna Government Hospital for Indian Medicine |
Room no 2
Siddha Department
Arignar Anna hospital
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU |
8870285172
sabarmathi44@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 |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
RASA CHENDURAM |
130 mg of Rasa chenduram is administrated orally once a day with Pepper powder for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 50 years
Both male and female
Arthritis of 3 or more joints
Morning stiffness more than 1 hour
Symmetrical Arthritis
Arthritis of hand joints
Anti-Cyclic citrullinated Peptide (Anti CCP) Positive |
|
| ExclusionCriteria |
| Details |
Age below 18 and above 50 years
Rheumatic fever
Psoriatic arthritis
Reiters arthritis
Gouty arthritis
Systemic Lupus Erythematosus
Progressive systemic sclerosis
Pregnant women and lactating mothers
Any other serious systemic illness
will be excluded clinically or based on available medical reports
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is mainly assessed by reduction in clinical symptoms measured by Universal pain assessment(Visual analogue scale) |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
10/12/2018 |
| 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)?
|
|
Brief Summary
|
This is a single Non-randomized open clinical trial to study the safety and efficacy of siddha trial drug RASA CHENDURAM. The trial drug is given 130mgs once a day for 48 days. Clinical trial is conducted after conducting preclinical toxicity study. The trial drug RASA CHENDURAM is mentioned in ANUBOGA VAIDHIYA NAVANEETHAM - Part V. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically. |