Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
None listed
Sponsors
GeneVec
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory, male and female subjects of 40-70 years of age with a Body Mass Index (BMI) of 22 to 29 kg/m2. 2. Subjects with Knee osteoarthritis grade II of Kellgren and Lawrence assessed based on X-ray. 3. Subjects with knee pain of 40-70 mm on a 100 mm visual analog scale (VAS) scale. 4. Willing to refrain from use of glucosamine, chondroitin, MSM, boswellia, turmeric, any other joint supplements, 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. 5. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 6. Results of screening are within normal range or considered not clinically significant by the Principal Investigator. 7. Subjects to discontinue the use of supplementations including vitamins, any other joint supplements, herbals or other topical applications. 8. Agree to participate in the study through a written informed consent. 9. Willing to comply with all the study related activities
Exclusion criteria
Exclusion criteria: 1. Previous injury and or surgery to the knee. 2. Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded. 3. Expectation of surgery during the study period. 4. Subjects with uncontrolled Diabetes (FPG >126 mg/dL) and Hypertension (Systolic > 140 mmHg and Diastolic >90 mmHg). 5. Subjects suffering from COPD or having history of any respiratory or breathing disorders. 6. Subjects used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders. 7. Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period. 8. Subjects having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products. 9. Have taken any corticosteroid, indomethacin, within 1 month prior to the enrollment or intra-articular treatment/injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment. 10. History of congestive heart failure or any vascular conditions. 11. Subjects with HIV Positive status. 12. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. 13. History of Systemic Lupus Erythematous (SLE). 14. Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers ( > 5 cigarettes per day). 15. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 16. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit. 17. Have taken acetaminophen/paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any herbal products within 7 days prior to the screening visit (visit 1). 18. History of heart, liver, lung cancer or chronic diseases. 19. Allergies to any ingredient in the investigational products. 20. Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of the Study in Total WOMACTimepoint: Baseline, Day 6,Day 14, Day 42 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of the Study in 6 min walk testTimepoint: Baseline, Day 6, Day 42 and Day 84;Change from Baseline to End of the Study in Biomarkers (Hs-CRP, TNF-α, MMP3 and IL-6)Timepoint: Baseline and Day 84;Change from Baseline to End of the Study in Isometric knee torqueTimepoint: Baseline, Day 6, Day 42 and Day 84;Change from Baseline to End of the Study in Lequesneâ??s Functional Index (LFI)Timepoint: Baseline, Day 6,Day 14, Day 42 and Day 84;Change from Baseline to End of the Study in Primary knee flexion rangeTimepoint: Baseline, Day 6, Day 42 and Day 84;Change from Baseline to End of the Study in Quality of Life questionnaire (SF-36)Timepoint: Baseline, Day 6, Day 42 and Day 84;Change from Baseline to End of the Study in Stair climb testTimepoint: Baseline, Day 6, Day 42 and Day 84;Change from Baseline to End of the Study in Urinary CTX-II (normalized by Creatinine)Timepoint: Baseline and Day 84;Change from Baseline to End of the Study in Visual Analogue Scale (VAS)Timepoint: Screening, Baseline, Day 6,Day 14, Day 42 and Day 84;Change from Baseline to End of the Study in WOMAC sub scales (pain, stiffness, physical function)Timepoint: Baseline, Day 6,Day 14, Day 42 and Day 84;Change from Baseline to End of the Study of Total anti-oxidant capacity (TAC)Timepoint: Baseline and Day 84;Use of Rescue medicationTimepoint: Day 6,Day 42,Day 84 | — |
Countries
India
Contacts
Public ContactDr Sowmya Bhat
Ayurlife Health Solutions
Outcome results
None listed