Health Condition 1: M15-M19- Osteoarthritis
Conditions
Interventions
Intervention1: GLMO-A: Oral Administration of 4 GLMO-A capsules once a day for 8 weeks
Intervention2: GLMO-B: Oral Administration of 4 GLMO-B capsules once a day for 8 weeks
Intervention3: GLMO-A: Ora
Sponsors
Great HealthWorks, Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject with Osteoarthritis (OA) (Class I-III), according to Kellgren and Lawrence system and confirmed by X-ray, who have been completely withdrawn from their previous analgesics or anti-inflammatory medications or have been newly diagnosed with mild to moderate OA, and who are not currently taking any analgesics or anti-inflammatory medications 2.Subjects with a body mass index (BMI) = 29.9 kg/m2 3.Subjects willing to and able to perform the treadmill walking test 4.Subject willing to and able to complete the questionnaires required for the study 5.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 6.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with any history of fracture involving the study joint or with any other type of arthritis or OA secondary to a known disorder such as rheumatoid arthritis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, and psoriasis. 2. Subjects who had surgery, or arthroscopy within three months prior to inclusion 3. Subjects with severe bone or joint deformation or condition 4. Subjects who have been administered hyaluronic acid injections within six months prior to screening and glucosamine and/or chondroitin containing compounds within seven days prior to the screening visit 5. Subjects who have used medications with MMP-inhibitory properties or took corticosteroids within 28 days of Screening Visit. 6. Subjects with history of Any chronic health condition,Psychiatric illness, Drug abuse, smoking, abuse or addiction to alcohol, Bariatric surgery or eating disorder such as bulimia or binge eating, Cardiovascular surgery, History of any other major surgery 7. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment 8. Subjects who have experienced a known stressful event within the last 6 months such as death in family, accident, hospitalization 9. Subjects with a known allergy to herbal products 10. Subjects who are pregnant or lactating or nursing 11. Known HIV or Hepatitis B positive or any other immuno-compromised state 12. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in questionnaire based assessments, scale and performance evaluationTimepoint: Day 0, Day 2, Day 28, Day 30,Day 56, Day 58, Day 84, Day 86 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in biomarker levelsTimepoint: Day 0, Day 28, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactJestin VThomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed