| CTRI Number |
CTRI/2024/06/068638 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| 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 on Poora Maathirai in the management of Uthiravatha suronitham (Rheumatoid Arthritis) among patients attending OPD and IPD of Government Siddha Medical College and Hospital, Palayamkottai |
|
Scientific Title of Study
|
A Prospective, open labelled, single arm, non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Poora Maathirai in the management of Uthiravatha suronitham (Rheumatoid arthritis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JANARTHANAN A |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital palayamkottai |
| Address |
OP number 10, PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli, India
Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7010614052 |
| Fax |
|
| Email |
janarthanan4797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Uma Kalyani |
| Designation |
Lecturer grade II |
| Affiliation |
Government Siddha Medical College and Hospital palayamkottai |
| Address |
OP number 10, PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli, India
Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8072685509 |
| Fax |
|
| Email |
sukgsmc2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T Komalavalli Alias Mehala |
| Designation |
Head Of the Department |
| Affiliation |
Government Siddha Medical College and Hospital palayamkottai |
| Address |
OP number 10, PG department of Pothu Maruthuvam,Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, India
Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of government siddha medical college and hospital, Tiruvananthapuram mail road,Palayamkottai, Tirunelveli-627002, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
| Address |
PG DEPARTMENT OF POTHU MARUTHUVAM, GOVERNMENT
SIDDHA MEDICAL COLLEGE, TIRUVANANTHAPURAM MAIN
ROAD, 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 |
| JANARTHANAN A |
Government Siddha Medical College and Hospital |
PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, India
Tirunelveli
TAMIL NADU |
7010614052
janarthanan4797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Government Siddha Medical College and Hospital, Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Poora Maathirai |
DOSAGE: 1 to 2 Tablets(Twice a day orally) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Pain and early morning stiffness
2.Those who are willing to participate in this study
3.RA factor test – positive
4.Anti CCP – positive
5.CRP above 20 mg/L
6.ESR elevated
7.ANA TEST in few selected cases
|
|
| ExclusionCriteria |
| Details |
1.Other degenerating joint diseases - osteoarthritis, sero negative spondylo arthritis, ankylosing spondylitis
2.Infectious joint diseases like, Tuberculosis, chronic poly arthritis in chickungunia viral infection.
3.Metabolic joint diseases like gout.
4.Patient who is on DMARD. (eg: methotrexate)
5.Pregnancy and lactating mother.
6.Chronic renal & liver disease patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing the symptoms of Uthiravatha suronitham (Rheumatoid Arthiritis) and to determine the efficacy of Poora Maathirai |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various Siddha literatures & modern journals for literature review on Uthiravatha suronitham.
2.To perform physicochemical, phytochemical, bio chemical analysis of Poora Maathirai.
3.To evaluate safety profile for acute & sub-acute toxicity of Poora Maathirai
4.To evaluate pharmacological activities of Poora Maathirai.
5.To study other cofactors related to disease like age, sex, dietary habits, family history, & socioeconomic status.
6.To study about the prevalence of Uthiravatha suronitham relation with diet & lifestyle.
7.To evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in Uthiravatha suronitham during trial period.
8.To evaluate dhegi of Uthiravatha suronitham patients.
9.To evaluate modern parametric changes in Uthiravatha suronitham.
10.To assess the quality of life of Uthiravatha suronitham patients.
11.To document Bio statistical analysis. |
6 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)
|
25/06/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is A Prospective, open labelled, single arm, non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Poora Maathirai in the management of Uthiravatha suronitham (Rheumatoid arthiritis). After purification of trial drugs, Poora maathirai will be prepared and administered at the dosage of 1 to 2 tablets for 48 days for 40 Rheumatoid Arthritis patients ( 20 OP and 20 IP Patients). The primary outcome will be to evaluate the therapeutic effectiveness of Siddha herbal Poora Maathirai in the management of Uthiravatha suronitham(Rheumatoid arthritis).The secondary outcome will be to collect various Siddha literatures and modern journals for literature review of Uthiravatha suronitham, to perform physicochemical, phytochemical, bio chemical analysis of Poora Maathirai, to evaluate safety profile for acute and sub-acute toxicity of -Poora Maathirai, to evaluate pharmacological activities of Poora maathirai, to study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status, to study about the prevalence of Uthiravatha suronitham relation with diet and lifestyleto evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) for Uthiravatha suronitham during trial period, to evaluate Dhegi of Uthiravatha suronitham patients, to evaluate modern parametric changes in Uthiravathasuronitham, to assess the quality of life of Uthiravatha suronitham patients, to document Bio statistical analysis. |