Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Maxicuma 100 capsule: 2 capsules of Maxicuma equivalent to 100 to be orally administered with water once daily after the breakfast for the treatment duration of 90 Days
Intervention2: M
Sponsors
India Glycols Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 45-65 years (both inclusive) of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2. 2. Unilateral or bilateral OA of the knee for greater than 3 months (NICE criteria) Note: According to the criteria from NICE, patients can be diagnosed with knee OA if they are 45 years or older, have movement-related joint pain and either no morning knee joint related stiffness or stiffness of 30 min or less. 3. Subjects with radiographic evidence by Kellgren - Lawrence grade 2 or 3 4. Female subjects of childbearing potential must be using a medically acceptable and reliable form of birth control. (Hormonal pills and intra-uterine devices are not considered as a reliable method of contraception). Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 5. VAS score during the most painful knee movement between 40-70 mm 6. Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs. 7. Screening parameters are within normal range or considered not clinically significant by the Principal Investigator 8. Drug naive subjects or subjects willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever including topical application (OTC or prescription) and Omega 3 fatty acids during the entire trial. 9. Willing to sign the informed consent and comply with study procedure.
Exclusion criteria
Exclusion criteria: 1. Female subjects, who are pregnant, breast feeding or planning to become pregnant. 2. Subjects with radiographic evidence by Kellgren - Lawrence grade 4. 3. Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin). 4. Patients who are allergic or hypersensitive to turmeric or turmeric supplements. 5. History or presence of underlying inflammatory arthropathy, RA, severe OA, gout, Systemic Lupus Erythematosus (SLE), any disorders related to bleeding/clotting or any other systemic disorder affecting joints. 6. Subjects scheduled for surgery within 3 months of completing the study. 7. Recent injury in the area affected by OA of the knee (past 4 months) 8. History or presence of congestive heart failure. 9. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies 10. High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) 11. History or presence of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 12. Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit 13. Have taken any corticosteroid, indomethacin, Glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Pain Visual Analogue Scale (VAS) [100 mm]. 2. Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) domain scores.Timepoint: Timepoints: Baseline- Prior Randomization, End of Study- Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Pain Visual Analogue Scale (VAS) [100 mm]. 2. Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) domain scores. 3. Change in Physical performance (assessed by treadmill walk test). 4. Comparison of proportion of subjects using rescue medication. 5. Comparison of Patients and physicians global assessment of therapy. 6. Comparison of treatment emergent Adverse events (AEs).Timepoint: 1. Baseline to Day 30, Day 45 & Day 60. 2. Baseline to Day 30, Day 45, & Day 60. 3. Baseline to Day 30, Day 45, Day 60 & Day 90. 5. Baseline to End of Study- Day 90 | — |
Countries
India
Contacts
Public ContactT Vijay Bhaskar
Invitro Research Solutions Pvt. Ltd
Outcome results
None listed