| CTRI Number |
CTRI/2018/01/011617 [Registered on: 30/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
An Ayurvedic Clinical study to evaluate the efficacy of different forms and doses of CURCUMIN for Rheumatoid Arthritis patients. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Four Arm, Parallel Group Study To Evaluate The Comparative Efficacy Of Different Forms And Doses Of Curcumin With That Of A Placebo In Active Rheumatoid Arthritis Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanna Mathad |
| Designation |
Vice Principal |
| Affiliation |
Nil |
| Address |
Shikashana Prasaraka Samitis
DHANVANTARI AYURVEDA COLLEGE
HOSPITAL AND RESEARCH CENTRE
SIDDAPUR
UTTARA KANNADA DIST. KARNATAKA
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
08389231551 |
| Fax |
|
| Email |
prasannamathad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Mathad |
| Designation |
Vice Principal |
| Affiliation |
Nil |
| Address |
Shikshana prasaraka samitis,
Dhanvantari ayurveda college
hospital and research centre,
Siddapur.
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
08389231551 |
| Fax |
|
| Email |
prasannamathad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeevan |
| Designation |
Project Manager |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
#17/51, 11th Cross, 1st Main, Sanjeevininagar, Bangalore
Bangalore
KARNATAKA
560072
India |
| Phone |
08971246104 |
| Fax |
|
| Email |
bd@agilepharmaservice.com |
|
|
Source of Monetary or Material Support
|
| Plant Lipids (P) Limited Kolenchery, Cochin -
682311, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Plant Lipids P Limited |
| Address |
Kolenchery, Cochin-682311, Kerala, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Prasanna S Mathad |
DHANVANTARI AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE |
Room Number3, Ayurvedic Department.
DHANVANTARI AYURVEDA COLLEGE
HOSPITAL AND RESEARCH CENTRE,
SIDDAPUR - 581355
UTTARA KANNADA DIST. KARNATAKA
Uttara Kannada
KARNATAKA |
09448630289
prasannamathad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DHANVANTARI AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
RHEUMATOID ARTHRITIS PATIENTS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active :CURCUMIN
Comparator:Plcebo |
All enrolled 48 subjects will be divided into four groups of 12 each. Each group will receive either treatment A, B C or D containing the same active ingredient |
| Intervention |
Curcumin 500 mg, Curcumin 250 mg, white curcumin |
oral route of administration, One capsule per day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i.Patients with active RA for at least one (1) year, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
ii.Receiving treatment on an outpatient basis.
iii.Active disease at the time of screening. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the comparative efficacy of curcumin (low & high dose), white curcumin with that of a placebo |
Screening – (Day - 7)
Baseline visit – (Day 0)
Visit 2 (Day 30)
Visit 3 (Day 60)
Visit 4 (Day 90) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. To assess the safety & tolerability of active products
b. To assess changes in various biomarkers during the study period among all the study group subjects.
|
Day 0
Day 30
Day 60
Day 90 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/02/2016 |
| Date of Study Completion (India) |
20/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized, double blind, placebo controlled,
four arm, parallel group study
To evaluate the comparative efficacy of curcumin
(low & high dose), white curcumin with that of a placebo
|