Clinical Study to evaluate the Efficacy and Safety of Curcumin in Patients with Chronic joint pain.

Phase 3

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue,

• Registration Number: CTRI/2018/12/016560
• Lead Sponsor: K PATEL Phyto Extractions Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-12
• Study Completion: 2019-06-15
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with Uncontrolled hypertension or diabetes.
• 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 Signs and symptoms as per instigator examination	screening and End of treatment
Changes in the Rheumatoid Arthritis impact measurement scale (AIMS 2)	screening and End of treatment
Change from Baseline in the CGI (Clinical Global Impression) scale score	screening and End of treatment
X ray and Anti CCP (anti cyclic citrullinated peptide) test result analysis	screening and End of treatment
Improvement in the PGIC scale (Patients global impression of change) and quality of life	screening and End of treatment

Secondary Outcome Measures

Name	Time	Method
•Safety assessed by Adverse Events	•Subjects questionnaire
Safety assessed by Adverse Events	Subjects questionnaire

Trial Locations

Locations (1)

Parul Institute of Ayurveda and Research Parul University Iswarapura,; 🇮🇳 Vadodara, GUJARAT, India

Parul Institute of Ayurveda and Research Parul University Iswarapura,

🇮🇳Vadodara, GUJARAT, India

Dr Prasanna S Mathad

Principal investigator

9845133229

prasannamathad@gmail.com