Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Aflapin 100 mg: One capsule daily in the morning after breakfast for 180 days
Control Intervention1: Placebo: One capsule daily in the morning after breakfast for 180 days
Sponsors
Sundyota Numandis Probioceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ââ?¬Â¢ Ambulatory, male and female subjects 40ââ?¬â??75 years of age with a Body Mass Index (BMI) of approximately 20 to 29 kg/m2. ââ?¬Â¢ Subjects with Knee osteoarthritis grade II or III of Kellgren and Lawrence scale. ââ?¬Â¢ Subjects diagnosed with articular cartilage defect in the knee (International Cartilage Repair Society (ICRS) grade II or III cartilage lesions as assessed on MRI scan). ââ?¬Â¢ VAS score between 40 and 70 mm pain while walking. ââ?¬Â¢ Willing to refrain from use of glucosamine, chondroitin, MSM, DMSO, doxycycline, ibuprofen, aspirin or other NSAIDS (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial. ââ?¬Â¢ Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrhic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. ââ?¬Â¢ Results of screening are within normal range or considered not clinically significant by the Principal Investigator. ââ?¬Â¢ No current intake of medications including vitamin supplements. ââ?¬Â¢ Agree to participate in the study through a written informed consent.
Exclusion criteria
Exclusion criteria: ââ?¬Â¢ Not willing to undergo MRI scan. ââ?¬Â¢ Previous surgery of the knee. ââ?¬Â¢ Expectation of surgery during the study. ââ?¬Â¢ Have severe knee pain (more than 70 mm on a 100-mm visual analogue scale, VAS) in most days of the last month. ââ?¬Â¢ Subjects with uncontrolled diabetes (Fasting blood sugar >140 mg/dl and blood pressure >130/90 mm Hg. ââ?¬Â¢ Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders. ââ?¬Â¢ Female subjects, who are pregnant, breast feeding or planning to become pregnant. ââ?¬Â¢ Subject having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products. ââ?¬Â¢ Using Natural Health Products (e.g. capsaicin, Boswellia, willow bark), creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding baseline. ââ?¬Â¢ Have taken any corticosteroid, indomethacin, glucosamine+chondroitin, within 1 month prior to the enrollment or intra-articular treatment/injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment. ââ?¬Â¢ History of congestive heart failure or any vascular conditions. ââ?¬Â¢ Subjects with HIV Positive status. ââ?¬Â¢ Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. ââ?¬Â¢ History of Systemic Lupus Erythematous (SLE). ââ?¬Â¢ Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.). ââ?¬Â¢ Subjects with smoking habit of >5 cigarettes a day ââ?¬Â¢ History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. ââ?¬Â¢ Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit. ââ?¬Â¢ Have taken acetaminophen / paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the Screening Visit (Visit 1). ââ?¬Â¢ History of heart, liver, lung cancer or chronic diseases. ââ?¬Â¢ Allergies to any ingredient in the investigational products. ââ?¬Â¢ Any other condition that, in the opinion of the investigator, would adversely affect the subjectââ?¬•s ability to complete the study or its measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in WOMAC Timepoint: Screening, Day 1, Day 30, Day 60, day 120 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in BiomarkersTimepoint: Day 1, Day 30 and Day 180;Change from baseline to the end of the study period in Cartilage Volume and thicknessTimepoint: Screening and Day 180;Change from baseline to the end of the study period in Joint space Timepoint: Screening and Day 180;Change from baseline to the end of the study period in LFITimepoint: Screening, Day 1, Day 30, Day 60, day 120 and Day 180;Change from baseline to the end of the study period in Six minute walk testTimepoint: Screening, Day 1, Day 30, Day 60, day 120 and Day 180;Change from baseline to the end of the study period in Stair climb testTimepoint: Screening, Day 1, Day 30, Day 60, day 120 and Day 180;Change from baseline to the end of the study period in VASTimepoint: Screening, Day 1, Day 30, Day 60, day 120 and Day 180 | — |
Countries
India
Contacts
Public ContactMr VARUN SUREJA
Sundyota Numandis Probioceuticals Pvt. Ltd
Outcome results
None listed