A study of Liposomal Curcumin in Arthritis
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2020/03/024221
- Lead Sponsor
- SSV Phytopharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Men and non-pregnant women who are at least 20 years and under 75 years of age; and
Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria
Pain defined by a level of greater than or equal to 5 on Numeric Pain Rating Scale (NPRS)
Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and
Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication.
Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.
Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.
Recent myocardial infarction (within the prior 12 weeks).
Unstable angina pectoris.
Known or suspected renal insufficiency defined as creatinine >1.5mg/dl.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the pain index was measured on Numeric Pain Rating Scale (NPRS) and Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain scoreTimepoint: 30 days
- Secondary Outcome Measures
Name Time Method Safety and efficacyTimepoint: 30 days