Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: LI13156F1: 60 mg per day: One capsule daily in the morning after breakfast for 60 days.
Intervention2: LI13108F: 100 mg per day: One capsule daily in the morning after breakfast for 60
Sponsors
Laila Nutra private limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory, male and female subjects aged between 40-70 years with body mass index (BMI) of 22-29.9 kg per meter square with the ability to walk. 2. Subjects with history of unilateral or bilateral Osteoarthritis (OA) of the knee for more than 3 months. 3. Subjects diagnosed with Knee osteoarthritis grade II or III of Kellgren and Lawrence based on X-ray. 4. VAS score during the most painful knee movement between 40 70 mm. 5. Subjects with sedentary lifestyle, no regular athletic or sports activities. 6. Subject agrees to maintain diet tracker. 7. Results of screening should be within normal range or considered not clinically significant by the Principal Investigator. 8. Females of childbearing potential who are sexually active must agree to use adequate contraception and can neither be pregnant nor lactating from screening throughout the duration of the study. 9. Ability to understand the risks, benefits of the protocol and willing to sign the written informed consent. 10. Subject agrees to avoid use of dietary supplements containing proteoglycans, hyaluronic acid, N acetyl glucosamine, glucosamine, chondroitin sulfate, collagen peptides, Curcumin, Boswellia or any other constituents of the test supplement for the duration of the study and within 3 months prior to enrollment. 11. Subject agrees to avoid use of medications for pain, including NSAIDS and any other oral or topical pain relief product with the exception of the rescue medication provided by the study site.
Exclusion criteria
Exclusion criteria: 1. Subjects with any possible signs/ indications/ history of severe arthritis, joint disorders including dislocations and quadriceps tendons tear. 2. History of underlying inflammatory arthropathy or severe Rheumatoid Arthritis or OA or Systemic Lupus Erythematosis (SLE). 3. Subjects with Hyperuricemia (men greater than 7 mg/dL, women greater than 6 mg/dL) and/or past history of gout. 4. Clinical history of bone or cartilage disorders including fracture and distortion within one year prior to enrolment. 5. Have taken any Intra-articular or Oral corticosteroids within 3 months prior to screening visit (Visit 1) or intra-articular treatment/injections with hyaluronic acid within 6 months preceding the treatment period. 6. Subjects with a history of knee or hip joint replacement surgery, or recent injury in the area affected by OA of the knee (past 4 months) and expectation of surgery in the next 4 months. 7. Any hip or back pain which interferes with ambulation. 8. Subjects with fasting glucose levels (greater than 126 mg/dL) and blood pressure (Systolic greater than or equal to 140 mmHg and Diastolic greater than or equal to 90 mmHg). 9. Female subjects who are pregnant, lactating or planning to become pregnant. 10. Subject having known allergy or suspected hypersensitivity or sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or investigational product or any other herbal products. 11. Have taken acetaminophen/ paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) within 5 days prior to the screening visit (Visit 1). 12. Use of other natural health products, including glucosamine and chondroitin, one month before and during the study. 13. 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. 14. Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol. 15. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 16. History of congestive heart failure or any vascular conditions. 17. Subjects with HIV Positive status. 18. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. 19. Subjects consuming alcohol (greater than 2 drinks per week) and smoking greater than 5 cigarettes per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.). 20. Any other condition that, in the opinion of the investigator, would adversely affect the subject s ability to complete the study or its measures. 21. Subjects who have participated or currently participating in another clinical trial within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Pain using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Timepoint: Days 1, 5, 30 & 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: WOMAC (stiffness, physical function and Total score) Timepoint: Days 1, 5, 30 & 60;Change from baseline to the end of the study period in: Pain using Visual Analogue Scale (VAS)Timepoint: Screening visit (5-7 days prior to randomization visit - Day 1) , Days 1, 5, 30 & 60;Change from baseline to the end of the study period in: Lequesne s functional index (LFI)Timepoint: Days 1, 5, 30 & 60;Change from baseline to the end of the study period in: 30 sec Chair Stand Test (30SCST)Timepoint: Days 1, 5, 30 & 60;Change from baseline to the end of the study period in: 6 minute walk test (SMWT)Timepoint: Days 1, 5, 30 & 60;Change from baseline to the end of the study period in: Primary Knee flexion range of motion (ROM)Timepoint: Days 1, 5, 30 & 60;Change from baseline to the end of the study period in: Use of rescue medicationTimepoint: Days 1, 5, 30 & 60;Change from baseline to the end of the study period in: Physician Global Assessment (PGA) and Subjective Global Assessment (SGA).Timepoint: Days 5, 30 & 60;Change from baseline to the end of the study period in: Biomarkers hs-CRP and Matrix Metalloproteinase -3 (MMP-3)Timepoint: Day 1 & Day 60 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar J
Laila Nutra Private Limited
Outcome results
None listed