Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
None listed
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1) Ambulatory, both male and female subjects 40ââ?¬â??75 years of age with a Body Mass Index (BMI) of 20 to 29 kg/m2. 2) Subjects with VAS score between 40-70 mm while walking. 3) Subjects with Knee osteoarthritis grade II or III of Kellgren and Lawrence assessed based on X-ray. 4) Subjects diagnosed with articular cartilage damage in the knee (International Cartilage Repair Society (ICRS) grade II or III cartilage lesions as assessed on MRI scan). 5) Subjects 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) or topical applications during the entire trial. 6) Female subjects of childbearing potential must be using a medically acceptable form of birth control. Post-menopausal women must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 7) Screening results are within normal range or considered not clinically significant by the Principal Investigator. 8) Subjects who are willing, able to understand and comply with all the study requirements. 9) Subjects agreed to participate in the study by a written informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects not willing to undergo MRI scan. 2) Any previous injury and or surgery to the knee. 3) Expectation of surgery during the study duration. 4) Have severe knee pain (more than 70 mm on a 100-mm visual analogue scale, VAS). 5) Subjects underwent treatment for COVID-19 or tested positive during the study will be excluded. Diabetic subjects with FPG >125 mg/dL and Hypertensive subjects with Systolic > 120 mmHg and Diastolic >80 mmHg. 6) Subjects who had 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 8) Subjects who are allergic to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products. 9) 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. 10) Have taken any corticosteroid, indomethacin, within 1 month prior to the enrolment or intra-articular treatment/injections with corticosteroid or hyaluronic acid within 6 months prior to enrolment. 11) Subjects with history of congestive heart failure or any vascular conditions liver, lung cancer or chronic diseases. 12) Subjects with HIV Positive status. 13) Evidence or history of clinically significant (with the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. 14) History of Systemic Lupus Erythematous (SLE). 15) Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.). 16) Subjects with smoking habit of >5 cigarettes a day. 17) History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 18) Participation in any other trials involving investigational or marketed products within 30 days prior to the screening Visit. 19) Have taken acetaminophen/paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product within 7 days prior to the Screening Visit (Visit 1). 20) Allergies to any ingredient of the study investigational products. 21) Any other condition that, in the opinion of the investigator would adversely affect the subjects ability to complete the study or its assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in WOMAC scoreTimepoint: 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 Cartilage volume and thickness using MRI (Cartigram)Timepoint: Screening (Baseline) and Day 180;Change from baseline to the end of the study period in Cartilage composition using MRI (dGEMRIC)Timepoint: Screening (Baseline) and Day 180;Change from baseline to the end of the study period in Isometric knee joint torqueTimepoint: Day 1, Day 30, Day 60, Day 120 and Day 180;Change from baseline to the end of the study period in Serum inflammatory biomarkers (hsCRP and MMP-3)Timepoint: Day 1, Day 30 and Day 180;Change from baseline to the end of the study period in Six-minute walk test scoreTimepoint: Day 1, Day 30, Day 60, Day 120 and Day 180;Change from baseline to the end of the study period in Subchondral bone marrow lesions (BML)using MRI (WORMS scoring system)Timepoint: Screening (Baseline) and Day 180;Change from baseline to the end of the study period in Timed up and go test scoreTimepoint: Day 1, Day 30, Day 60, Day 120 and Day 180;Change from baseline to the end of the study period in Urinary CTX-II (Normalized with Creatinine)Timepoint: Day 1 and Day 180;Change from baseline to the end of the study period in VAS scoreTimepoint: Screening, Day 1, Day 30, Day 60, Day 120 and Day 180;Change from baseline to the end of the study period LFI scoreTimepoint: Day 1, Day 30, Day 60, Day 120 and Day 180 | — |
Countries
India
Contacts
Public ContactAlluri Venkata Krishna Raju
Laila Nutraceuticals
Outcome results
None listed