| CTRI Number |
CTRI/2019/05/019031 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
08/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on Kodiveli chooranam for Vali Azhal Keel Vayu(Rheumatoid Arthritis) |
|
Scientific Title of Study
|
A Prospective open labelled phase-II Non-randomized clinical trial on
kodiveli chooranam for the tratment of Vali Azhal Keel Vayu(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 Srikajan |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9384121796 |
| Fax |
|
| Email |
srikajan1978@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD PhD |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Komalavalli MD PhD |
| Designation |
Associate Professor |
| Affiliation |
Govt Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD facilities and central library of Govt Siddha Medical College and Hospital
|
|
|
Primary Sponsor
|
| Name |
Govt Siddha Medical College and Hospital |
| Address |
Palayamokottai
Tirunelveli
TamilNadu
627002 |
| 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 Srikajan |
Govt Siddha Medical College and Hospital |
OP Number10
PG Department of Pothu maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
9384121796
srikajan1978@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 |
Kodiveli Chooranam |
20mg/kg/Body weight BD B/F with water for 45 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 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
5.Extra pulmonary tuberculosis |
|
|
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. |
45days |
|
|
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 |
45days |
|
|
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)
|
13/05/2019 |
| 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
|
None yet |
|
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 KODIVELI CHOORANAM in the management of vali azhal keel vayu (Rheumatoid arthritis).The trial drug will be administered at the dose of 20mg/kg/Body weight BD before food along with water 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 TamilNadu. The Primary out come will be the evaluation of therapeutic efficacy of trial drug KODIVELI CHOORANAM . The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of trial drug |