Clinical Study to evaluate the Efficacy and Safety of Curcumin in Patients with Chronic joint pain.
- Conditions
- Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- CTRI/2018/12/016560
- Lead Sponsor
- K PATEL Phyto Extractions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in the PGIC scale (Patients global impression of change) and quality of life <br/ ><br>Improvement in Signs and symptoms as per instigator examination <br/ ><br>Changes in the Rheumatoid Arthritis impact measurement scale (AIMS 2) <br/ ><br>Change from Baseline in the CGI (Clinical Global Impression) scale score <br/ ><br>X ray and Anti CCP (anti cyclic citrullinated peptide) test result analysis <br/ ><br>Timepoint: screening and End of treatment
- Secondary Outcome Measures
Name Time Method â?¢Safety assessed by Adverse Events <br/ ><br>â?¢Subjects questionnaire <br/ ><br>Timepoint: screening and EOT;Safety assessed by Adverse Events <br/ ><br>Subjects questionnaire <br/ ><br>Timepoint: screening to End of the treatment