| CTRI Number |
CTRI/2018/06/014450 [Registered on: 07/06/2018] Trial Registered Prospectively |
| Last Modified On: |
06/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of drug NANNARI VER OORAL KUDINEER in VALI AZHAL KEEL VAYU( Rheumatoid arthritis) |
|
Scientific Title of Study
|
A prospective open labelled phase II Non randomized clinical trial on herbal formulation of NANNARI VER OORAL KUDINEER for the treatment 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 |
Malarvizhi E |
| Designation |
PG Student |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
PG Second Year Department of Pothumaruthuvam Govt Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8807183465 |
| Fax |
|
| Email |
malarvizhielumalai90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G Subash Chandran MD Siddha PhD |
| Designation |
Lecturer |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Department Of Pothumaruthuvam Govt Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G Subash Chandran MD Siddha PhD |
| Designation |
Lecturer |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Department Of Pothumaruthuvam Govt Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD Govt Sidhha Medical College and hospital palayamkottai. Library Govt siddha medical college and hospital palayamkottai |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
Govt Siddha Medical College and hospital Palayamkottai Tirunelveli 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 |
| Malarvizhi E |
Govt Siddha Medical college and hospital |
Opd Room Number 10 PG Department of Pothu Maruthuvam Government Siddha Medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU |
8807183465
malarvizhielumalai90@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 |
VALI AZHAL KEEL VAYU, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NANNARI VER OORAL KUDINEER |
90ml Orally Thrice a day Before food for 30 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Symmetrical joint involvement Arthritis of 3 or more joints Florid morning stiffness and swelling that lasts for few hours or days Pain joints swelling especially in the interphalangeal joints Pain criteria score should be greater than or equal to 6 |
|
| ExclusionCriteria |
| Details |
Age below 18 and above 50 years Gouty arthritis Psoriatic arthritis Mixed connective tissue disorders SLE Extra pulmonary tuberculosis Other auto immune disease Chronic kidney disease Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of trial drug nannari ver ooral kudineer in vali azhal keel vayu |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of siddha diagnostic parameters safety of trial drug pharmacological and Biochemical analysis of trial drug |
30 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)
|
13/06/2018 |
| 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="2"
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 NANNARI VER OORAL KUDINEER 90ml TDS for 30 days in 40 patients during the trial period of 14 month that will be contacted in Goverment Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu The Primary outcome will be the therapeutic efficacy of trail drug NANNARI VER OORAL KUDINEER in VALI AZHAL KEEL VAYU The secondary outcome will be the evaluation of Sidha diagnostice parameters safety of trail drug Pharmacolocical and Biochemical analysis of trail drug |