Health Condition 1: M17- Osteoarthritis of knee
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 18 to 70 years of age with 1:1 ratio. 2. NRS score of â?¥ 5 pain at the time of screening. 3. BMI 18 to 29kg/m2. 4. WOMAC score for Pain - 2 or more for any two activities. Stiffness â?? 1 or more for any one activity. Physical function â?? sub-score 10 or more. 5. Doctor diagnosed OA of knee â??with Kellgrenâ??Lawrence classification grades 2-3. 6. Ability to follow all instructions in the study protocol and be willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of any underlying back pain, inflammatory arthropathy, rheumatoid arthritis, severe osteoarthritis, fibromyalgia, gout or knee surgery within the past 6 months. Additionally, include any anticipated surgeries in the next 4 months and details of any hyaluronic acid treatments, either alone or in combination with Intra-articular corticosteroid injections received within the past 3 months. 2. BMI â?¥ 30. 3. Alcohol dependence 4. Smoking status more than 1 pack cigarettes per day. 5. Psychotic tendencies such as schizophrenia, taking any psychotropic medicines. 6. Psychedelic or narcotic substance use. 7. Co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease or limit normal function in the judgment of the investigator. 8. History of the use ointments used for pain within the past 2 weeks, any antibiotics, NSAIDs, steroids, over-the-counter pills as well as any supplements taken for joint pain three months prior to your screening. 9. 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. 10. Positive pregnancy, breast feeding, pregnancy planning. 11. Subjects who have participated in a similar investigation in the past three months. 12. Unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the WOMAC recommended index of joint painTimepoint: Baseline, Week 6, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess OARSI performance-based testsTimepoint: Baseline, Week 6, Week 12;Change in NRS scoreTimepoint: Baseline, Week 6, Week 12;Change in anti-inflammatory and antioxidant biomarkersTimepoint: Baseline, Week 6, Week 12;To assess the safety by blood biochemistry, vitalsTimepoint: Baseline, Week 12 | — |
Countries
India
Contacts
Arjuna Natural Private Limited