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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2018
INTERVENTION: Intervention1: Dr. Prasanna S. Mathad: Dr. Prasanna S. Mathad Assistant Professor Dept. of Rasashastra and Bhaishajya Kalpana. Parul Institute of Ayurveda and Research Parul University Iswarapura, Tq: Waghodia District: Vadodara Gujrat‐391760 Intervention2: PLACEBO: Placebo CAPSULE K. Patel phyto Extraction Pvt. Ltd., Village Talwada, Behind Old Sales Tax check Post, NH‐8, Bhilad, Taluka: Umergaon, District: valsad, Gujarat‐ 396105 Intervention3: Curcumin (35 % curcuminoids)capsule: K. Patel phyto Extraction Pvt. Ltd Intervention4: Curcumin (35 % curcuminoids): Pharmaceutical form Capsule Dosing schedule in the study,2 capsules per day ( two times in a day ) Control Intervention1: placebo: placebo capsule Manufacturing Company: K. PATEL Phyto Extractions Pvt. Ltd. Control Intervention2: Curcumin (35 % curcuminoids)bioavailable capsule: K. Patel phyto Extraction Pvt. Ltd., Village Talwada, Behind Old Sales Tax check Post, NH‐8, Bhilad, Taluka: Umergaon, District: valsad, Gujarat‐ 396105 Control Intervention3: placebo capsule: K. Patel phyto Extraction Pvt. Ltd., Village Talwada, Behind Old Sales Tax check Post, NH‐8, Bhilad, Taluka: Umergaon, District: valsad, Gujarat‐ 396105 Control Intervention4: Placebo: Pharmaceutical form Capsule Dosing schedule in the study‐2 capsules per day ( two times in a day ) CONDITION: Diseases of the musculoskeletal system and connective tissue PRIMARY OUTCOME: 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 ; Timepoint: screening and End of treatment SECONDARY OUTCOME: â?¢Safety assessed by Adverse Events ; â?¢Subjects questionnaire ; Timepoint: screening and EOT Safety assessed by Adverse Events ; Subjects questionnaire ; Timepoint: screening to End of the treatment 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
Epistemonikos ID: 71654f827eeac73d07579efbf3581d809fbb251b
First added on: Mar 24, 2022