Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: TAMAFLEX: Randomized Subjects are advised to take one capsule daily in the morning after breakfast.
Intervention2: TAMAFLEX Plus: Randomized Subjects are advised to take one capsule dai
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory, male and female subjects of 40ââ?¬â??70 years of age with a Body Mass Index (BMI) of 20 to 29 kg/m2. 2. Subjects with VAS score between 40 and 70 mm. 3. Subjects with Knee osteoarthritis grade II to III of Kellgren and Lawrence assessed based on X-ray. 4. 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. 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 ready to discontinue the use of supplementations including vitamins, glucosamine + chondroitin, 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. Expectation of surgery during the study period. 3. Subjects with uncontrolled Diabetes (FPG >125 mg/dL) and Hypertension (Systolic > 120 mmHg and Diastolic >80 mmHg). 4. Subjects suffering from COPD or having history of any respiratory or breathing disorders. 5. Subjects used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders. 6. Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period. 7. Subjects having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products. 8. 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. 9. History of congestive heart failure or any vascular conditions. 10. Subjects with HIV Positive status. 11. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. 12. History of Systemic Lupus Erythematous (SLE). 13. Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.). 14. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 15. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit. 16. Have taken acetaminophen or 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) 17. History of heart, liver, lung cancer or chronic diseases 18. Allergies to any ingredient in the investigational products 19. 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 the end of the study period in WOMAC and sub scores Timepoint: Baseline to end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs), frequency and severityTimepoint: Baseline to end of the study;Change from baseline to the end of the study period in VASTimepoint: Baseline to end of the study;Change from baseline to the end of the study in Biomarkers (MMP-3, Hs-CRP, TNF- Alpha, IL -6 and uCTX-II)Timepoint: Base line to end of the study;Change from baseline to the end of the study in period Six minute walk test (SMWT)Timepoint: Baseline to end of the study;Change from baseline to the end of the study period in LFITimepoint: Baseline to end of the study;Change from baseline to the end of the study period in Primary Knee flexion range of motionTimepoint: Baseline to end of the study;Change from baseline to the end of the study period in Stair climb test (SCT)Timepoint: Baseline to end of the study;Changes in vital parameters and laboratory investigationsTimepoint: Baseline and end of the study;Number of subjects who discontinue study due to adverse eventsTimepoint: Baseline to end of the study | — |
Countries
India
Contacts
Public ContactAlluri Venkatakrishna Raju
Laila Nutraceuticals
Outcome results
None listed