| CTRI Number |
CTRI/2020/03/024153 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
21/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on Meganathi kuligai for UthiraVatha suronitham(Rheumatoid Arthritis) |
|
Scientific Title of Study
|
A prospective open labelled non randomized phase II clinical study on Mekanati kulikai for uthiravata curonitam (Rheumatoid arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Sathiya |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of pothu Maruthuvam Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TamilNadu
627 002
India
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TamilNadu
627 002
India
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9884132729 |
| Fax |
|
| Email |
Anbuthozher@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD s PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of pothu Maruthuvam Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TamilNadu
627 002
India
Department of pothu Maruthuvam Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TamilNadu
627 002
India
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MD s PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of pothu Maruthuvam Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TamilNadu
627 002
India
Department of pothu Maruthuvam Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TamilNadu
627 002
India
TAMIL NADU
627 002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government siddha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TamilNadu
627 002
India
|
| 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 |
| R Sathiya |
Government siddha medical college |
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TamilNadu
627 002
India
Tirunelveli
TAMIL NADU |
9884132729
Anbuthozher@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 |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Meganathi Kuligai |
1/2-1 Kundri Edai (60-130mg)/kg BW/Twice a day(orally) with honey for 45 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Symmetrical joint involvement
2.Involvement of 3 or more joints
3.Florid morning stiffness and swelling that lasts for few hours or days
4.pain,joint swelling especially in the interphalangeal joints
5.pain criteria score should be greater than or equal to 6. |
|
| ExclusionCriteria |
| Details |
1.Psoriatic arthritis
2.Gout
3.Mixed connective tissue disorders
4.SLE |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reducing the pain, swelling, early morning stiffness,deformities.
2.To assess improvement based on the disease activity pain score. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of addition effects and siddha parameters during trial period.
2. Determination of safety profile of trial drug .
3. Evaluation of Bio Chemical investigation parameters. |
45 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)
|
02/04/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a prospective open labelled phase II Non-Randomized clinical study to evaluate the therapeutic efficacy of Meganathi Kuligai in the management of Uthiravatha Suronitham ( Rheumatoid Arthritis). The trial drug will be administered at the dose of 1/2-1 Kundri Edai (60-130mg)/kgBW/ Twice a day(orally) with Honey as adjuvant for 45 days in 40 patients. The trial period of 12 months will be carrying out in Government siddha medical college and hospital, Palayamkottai, Tirunelveli, Tamil Nadu 627 002. The primary out come will be the evaluation of therapeutic efficacy of trial drug Meganathi Kuligai. The secondary outcome will be the evaluation of siddha diagnostic parameters, assessment of safety profile of trial drug , assessment of pharmacological and Bio chemical parameters of trial drug. |