To understand the safety and efficacy of Maxicuma® 100 Capsules and Maxicuma® 250 Capsules in patients suffering from knee pain. ?
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2023/04/052147
- Lead Sponsor
- India Glycols Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method