Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Turmeric-Boswellia extract: Turmeric-Boswellia extract in sesame oil (Rhuleave-K)
500mg once daily for 12 weeks
Control Intervention1: Placebo: Polysorbate 80, PEG 400
500 mg once da
Sponsors
Arjuna Natural Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female 18 to 70 years of age with 1:1 ratio NRS score greater than or equal to 5 pain at the time of screening. BMI 18-29kg/m2. WOMAC score for Pain - 2 or more for any two activities. Stiffness – 1 or more for any one activity. Physical function – sub score 10 or more. Doctor diagnosed OA of knee – with Kellgren–Lawrence classification grades 2-3.
Exclusion criteria
Exclusion criteria: History of underlying back pain, all kinds of inflammatory arthropathy and rheumatoid arthritis, severe osteoarthritis, fibromyalgia, gout and history of knee surgery within the past 6 months, expectations of surgery in the next 4 months, hyaluronic acid alone or along with Intra-articular corticosteroid injections within the preceding 3 months. BMI greater than or equal to 30. High alcohol intake ( greater than 2 standard drinks per day). Smoking status not more than 1 pack per day. Psychotic tendencies such as schizophrenia, taking any psychotropic medicines. Psychedelic or narcotic substance use. Co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease or limit normal function. Concomitant medications antibiotics, NSAIDS, steroids, OTC pills and ointments for pain 1 week, taking any kind of supplements for joint pain before screening. Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study. Positive pregnancy, breast feeding, pregnancy planning. Subjects who have not participated in a similar investigation in the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in womac total scoreTimepoint: Baseline, day 5, weeks 6 & 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in OARSI performance-based tests scoreTimepoint: Baseline, day 5, weeks 6 & 12.;Change in present pain intensity as measured using NRS scaleTimepoint: Baseline, day 5, weeks 6 & 12.;Change in range of motion as measured by goniometry scoreTimepoint: Baseline, day 5, weeks 6 & 12. | — |
Countries
India
Contacts
Public ContactSooraj Rajasekharan Kartha
Arjuna Natural Pvt Ltd
Outcome results
None listed