| CTRI Number |
CTRI/2017/05/008469 [Registered on: 03/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2017 |
| 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 evaluate the efficacy of Siddha drugs Gandhaga Rasayanam (Internal) & Navanatha sittha thailam (External) in patients having multiple joint pain |
|
Scientific Title of Study
|
An open pilot study on Uthiravatha suronitham (Rheumatoid arthitis) with the trial drug Gandhaga rasayanam (Internal) and Navanatha sittha thailam (Ext) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Shrisaranya |
| Designation |
PG Scholor |
| Affiliation |
Govt siddha medical college |
| Address |
Department of sirappu maruthuvam,
Govt siddha medical college,
No.6, Anna arch Road, NSK Nagar, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8098372738 |
| Fax |
|
| Email |
drshrisaranya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Shrisaranya |
| Designation |
PG Scholor |
| Affiliation |
Govt siddha medical college |
| Address |
Department of sirappu maruthuvam,
Govt siddha medical college,
No.6, Anna arch Road, NSK Nagar, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8098372738 |
| Fax |
|
| Email |
drshrisaranya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Mohamed mustafa |
| Designation |
Head of the department |
| Affiliation |
Govt siddha medical college |
| Address |
Department of sirappu maruthuvam,
Govt siddha medical college,
No.6, Anna arch Road, NSK Nagar, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9444190077 |
| Fax |
|
| Email |
spmhibiscus@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt siddha medical college,
No.6, Anna arch Road, NSK Nagar, Arumbakkam, Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Govt siddha medical college |
| Address |
Dept. of sirappu maruthuvam,
Govt siddha medical college,
Chennai, 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 M Shrisaranya |
Arignar Anna Hospital of Indian Medicine and Homoeopathy |
Room No.4, Siddha Division, Department of Sirappu maruthuvam, Arignar Anna Hospital of Indian Medicine and Homoeopathy, Arumbakkam, Chennai 600106
Chennai
TAMIL NADU |
8098372738
drshrisaranya@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 |
Patients having arthritis of three or more joints , Patients having RA factor POSITIVE , morning stiffness, CRP positive and anemia., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gandhaga rasayanam (int) |
Gandhaga rasanayam (int)_500mg twice daily with hot water for 48 days |
| Intervention |
Navanadha sittha thailam (ext) |
Navanadha sittha thailam (ext)_10ml external application for 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having arthritis of 3 or more joints
2. Morning stiffness
3. RA factor positive
4. C-Reactive Protein (CRP) positive
5. Anti Cyclic Citrullinated Peptide (Anti CCP) Positive
5. Patients who are willing to undergo laboratory investigations |
|
| ExclusionCriteria |
| Details |
1. Rheumatic fever
2. History of sulphur allergy
3. Psoriatic arthropathica,
4. Progressive systemic sclerosis
5. Gouty arthritis,
6. Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain and swelling and morning stiffness |
12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the safety parameters of the drug before and after treatment |
12months |
|
|
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)
|
16/08/2016 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a Non Randomized open clinical trial. During this trial period 500 mg of Gandhaga Rasayanam (Internal) with hot water, twice a day and 10 ml of Navanatha Sittha thailam (External) is administered for 48 days in patients having Uthiravatha suronitham (Rheumatoid arthritis). All the details regarding the study will be documented and the result will be published. |