| CTRI Number |
CTRI/2017/05/008574 [Registered on: 16/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of Rasa chendhuram internal drug for symmetrical multiple joints(Rheumatoid arthritis) |
|
Scientific Title of Study
|
An open comparative clinical study on Udhira vadha suronitham Rheumatoid arthritis with the evaluation of siddha trial drugs Rasa chendhuram(int)Roga sanjeevi thylam(ext)Ottradam
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C ARUNA |
| Designation |
Pg scholar |
| Affiliation |
Govt siddha medical college |
| Address |
Government siddha medical college
Department of sirappu maruthuvam
Room number-4
6th Anna arch road nsk nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9789974091 |
| Fax |
|
| Email |
arunahasanc7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M MOHAMED MUSTHAFA |
| Designation |
Reader |
| Affiliation |
Govt siddha medical college |
| Address |
Govt siddha medical college Department of sirappu maruthuvam
Room number-4
6th Anna arch road nsk nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9444190077 |
| Fax |
|
| Email |
spmhibiscus@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C ARUNA |
| Designation |
Pg scholar |
| Affiliation |
Govt siddha medical college |
| Address |
Govt siddha medical college
Department of sirappu maruthuvam
Room number -4
6th Anna arch road nsk nagar
Arumbakkam
chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9789974091 |
| Fax |
|
| Email |
arunahasanc7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt siddha medical college 6th Anna arch road nsk nagar
Arumbakkam
Chennai |
|
|
Primary Sponsor
|
| Name |
Govt siddha medical college |
| Address |
Govt siddha medical college 6th Anna arch road nsk Nagar
Arumbakkam
Chennai |
| 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 C ARUNA |
Arignar anna hospital Govt siddha medical college |
Govt siddha medical college
Department of sirappu maruthuvam Room number -4
Arumbakkam
Chennai
Tamil nadu
Chennai
TAMIL NADU |
9789974091
arunahasanc7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having arthritis of three or more joints pain and swelling in the distal interphalangeal joints morning stiffness patients having RAfactor positive Anti ccp positive and aneamia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Rasa chendhuram(Int) 2.Roga sanjeevi thylam(Ext) |
1.20Patients treated with rasa chendhuram (int)-65mg twice daily with honey and Roga Sanjeevi thylam (ext) application for48days |
| Intervention |
1.Rasa chendhuram(Int). 2.Roga sanjeevi thylam (Ext). 3.Ottradam |
20Patients treated with Rasa chendhuram (int)-65mg twice daily with honey and Roga Sanjeevi thylam(ext) application and ottradam for 48days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 Years
Both male and female
Morning stiffness
Pain and swelling in the distal interphalangeal Joints.
RA Factor positive
ANTI CCP POSITIVE
ARTHRITIS OF MORE THAN THREE JOINTS |
|
| ExclusionCriteria |
| Details |
Ankylosing Spondylitis
Rheumatic fever
Systemic lupus erythymatosus
Gouty arthritis
History of long term intake of steroids
Osteomyelitis
Pregnant women and lactatin mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the pain and morning stiffness |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the safety profile of the drug before and after treatment. |
12 Months |
|
|
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)
|
14/07/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients satisfying the
inclusion and exclusion criteria will be included in the trial. Modern
investigations will be carried out before treatment and at the end of the
treatment. At the end of the study the trial patients are advised to report
when there is recurrence. |