| CTRI Number |
CTRI/2018/02/012040 [Registered on: 21/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2018 |
| 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 trial drug MATHIYOOSHNA RASAYANAM(Internal),NYMPATHY THYLAM(External)on UTHIRAVATHA SURONITHAM (Rheumatoid Arthritis). |
|
Scientific Title of Study
|
An Open Clinical Study to evaluate the clinical efficacy of siddha sasthric formulation "MATHIYOOSHNA RASAYANAM "(Internal)"NYMPATHYTHYLAM" for the treatment of UTHIRAVATHA SURONITHAM. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Aysha |
| Designation |
Pg student |
| Affiliation |
Govrnment Siddha Medical College |
| Address |
Department Of Pg Sirappu Maruthuvam
Govrnment Siddha Medical College
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
aysha.mdsiddha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S Poongodi kanthimathi |
| Designation |
HOD of the department |
| Affiliation |
government siddha medical college |
| Address |
Department Of Pg Sirappu Maruthuvam
Govrnment Siddha Medical College
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Aysha |
| Designation |
Pg student |
| Affiliation |
Govrnment Siddha Medical College |
| Address |
Department Of Pg Sirappu Maruthuvam
Govrnment Siddha Medical College
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
aysha.mdsiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of pg sirappu maruthuvam department government siddha medical college
Library of government siddha medical college
|
|
Primary Sponsor
Modification(s)
|
| Name |
Dr S Neelavathi |
| Address |
Principal
Government siddha medical college and hospital
palayamkottai
Tirunelveli
|
| 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 S Aysha |
Government Siddha Medical College |
OP No 4
Pg sirappu maruthuvam department
Tirunelveli
TAMIL NADU |
8428621182
aysha.mdsiddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pain in all major and minor joints
swelling of joints
morning stiffness more then one hour
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mathiyooshna Rasayanam 6.022 gm(twice a day)(Internal)
Nympathy Thylam 30 ml(External)for 40 days
|
Mathiyooshna Rasayanam 6.022 gm(twice a day)(Internal)
Nympathy Thylam 30 ml(External)for 40 days |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Symmetrical joint involvement
Arthritis of 3 or more joints.
Rheumatoid factor positive or negative
Morning stiffness.
Swelling especially in the inter phalangeal joint.
Patients who are willing for admission and stay in IPD for 40 days or willing to attend OPD
Patient who is willing to undergo radiological investigation and give blood and urine samples for laboratory investigation.
Patient willing to sign the informed consent stating that he/she will consciously stick to the treatment during 40 days but can OPD out of the trial of his/her own conscious discretion.
|
|
| ExclusionCriteria |
| Details |
Systemic illness
Pregnancy and lactation
History of trauma
Neurological disorder
Tubercular arthritis
Any other serious illness
Psoriatic arthritis
Gouty arthritis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the pain and weakness |
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha Diagnostic Parameters |
40 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)
|
05/09/2017 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Phase II
criteria based clinical study to evaluate the clinical efficacy of siddha herbo
mineral formulation of
Mathiyooshna Rasayanam(Internal) 6.002gram Bd and
Nympathy Thylam 30 ml (External) on UTHIRAVATHA
SURONITHAM (Rheumatoid Arthritis) for 40 days
in 40 patients during the trial period of 1 year 6 months that will be
conducted in government siddha medical college palyamkottai tamil nadu the
primary out come is Reducing the pain and weakness by the trail drug Mathiyooshna Rasayanam (Internal) and Nympathy Thylam (external) the secondary outcome will be the Evaluation of siddha diagnostic
parameters.
|