| CTRI Number |
CTRI/2018/12/016560 [Registered on: 07/12/2018] Trial Registered Prospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study to evaluate the Efficacy and Safety of Curcumin in Patients with Chronic joint pain. |
|
Scientific Title of Study
|
A Prospective, Interventional, Randomized, Parallel, Double blind, Placebo Controlled Clinical Study to evaluate the Efficacy & Safety of Curcumin in Patients with Chronic joint pain (Rheumatoid Arthritis). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/KPPE/0710/83 Version:01 Dated:10 Jul 2018 |
Protocol Number |
| ICBio/CR/KPPE/0710/83 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanna S Mathad |
| Designation |
Associate professor ( physician Ayurveda ) |
| Affiliation |
Parul institute of ayurveda and research |
| Address |
Parul institute of ayurveda and research, faculaty of ayurveda, Parul university Iswarapura Tq. Waghodia,
Vadodara
GUJARAT
391760
India |
| Phone |
912668260219 |
| Fax |
2668260201 |
| Email |
prasannamathad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
ICBio Clinical Research Pvt. Ltd.
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore - 560 097, India
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
ICBio Clinical Research Pvt. Ltd.
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore - 560 097, India
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| K. PATEL Phyto Extractions Pvt. Ltd.
A/101, Alaknanda,
Annasaheb Vartak Marg, TPS III
Borivali W, Mumbai: 400092
|
| K. PATEL Phyto Extractions Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
K PATEL Phyto Extractions Pvt Ltd |
| Address |
Village Talwada, Behind Old Sales Tax check Post,
NH-8, Bhilad,
Taluka: Umergaon, District: valsad,
Gujarat- 396105
|
| 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 |
Parul Institute of Ayurveda and Research Parul University Iswarapura, |
Parul Institute of Ayurveda and Research
Parul University Iswarapura,
Tq: Waghodia District: Vadodara
Gujrat-391760
Vadodara
GUJARAT |
9845133229
2668260201
prasannamathad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curcumin (35 % curcuminoids) |
Pharmaceutical form Capsule Dosing schedule in the study,2 capsules per day ( two times in a day ) |
| Comparator Agent |
Placebo |
Pharmaceutical form Capsule Dosing schedule in the study-2 capsules per day ( two times in a day ) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Men and women with age of 40 to 65 with a diagnosed Rheumatoid Arthritis from last 3 month.
2.Willing to give written informed consent.
Participants who are able to visit the medical institutions throughout the study period
3. Subjects who have not participated in a similar investigation in the past 3 month
4. Subject is willing and able to comply with all trial requirements
|
|
| ExclusionCriteria |
| Details |
1. Patients with Uncontrolled hypertension or diabetes.
2. Patients with Hepatic or renal impairment
3. Patients with Current or expected use of anticoagulant
4.Candidates for imminent joint replacement
5. Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
6.Participation within 30 days prior to screening in another investigational study
7.Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
Any serology positive
Pregnant (or) Lactating
Previous history of allergic reaction to curcumin
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the PGIC scale (Patients global impression of change) and quality of life
Improvement in Signs and symptoms as per instigator examination
Changes in the Rheumatoid Arthritis impact measurement scale (AIMS 2)
Change from Baseline in the CGI (Clinical Global Impression) scale score
X ray and Anti CCP (anti cyclic citrullinated peptide) test result analysis
|
screening and End of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Safety assessed by Adverse Events
•Subjects questionnaire
|
screening and EOT |
Safety assessed by Adverse Events
Subjects questionnaire
|
screening to End of the treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/12/2018 |
| Date of Study Completion (India) |
15/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
15. Sambaiah, K., Ratankumar, S., Kamanna, V. S., Satyanarayana, M. N., Rao, M. V. L. (1982) J. Food Sci. Technol. 19, 187—190. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The Curcuminoid are natural phenols that are responsible for the yellow color of turmeric. Curcumin can exist in several tautomeric forms, including a 1, 3-diketo form and two equivalent enol forms. The present study is conducted to evaluate safety and efficacy of Curcumin in Patients with Chronic joint pain (Rheumatoid Arthritis).
30 subjects was enrolled in the study. |