CTRI/2023/04/052147CompletedPhase 3
A Randomized, Double Blind, Placebo Controlled, Three Treatment, Parallel Group Study to Evaluate the Safety and Efficacy of Maxicuma® 100 Capsules and Maxicuma® 250 Capsules in patients with Osteoarthritis of Knee
India Glycols Ltd0 sites180 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 180
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •9. Willing to sign the informed consent and comply with study procedure.
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
- •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.
Investigators
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