Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
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,
Sponsors
K PATEL Phyto Extractions Pvt Ltd
Eligibility
Inclusion criteria
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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed