Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: Tablet Bonivia: Dose: 750 mg
Frequency: Twice daily
Route of administration: Oral
Duration of intervention: 6 months
Sponsors
Sava Healthcare Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Overweight individuals (BMI: 23.5 - 29.9kg/m2) of either sex aged 40-65 years without any history of hypertension or diabetes. 2.Individuals diagnosed with KL (Kellgren and Lawrence) Grade 1 or Grade 2 osteoarthritis, displaying early degenerative changes on MRI and experiencing moderate knee pain for at least 3 months. 3.Individuals in generally good health who can abide by the study protocol 4.Individuals willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1.Individuals with a history of fracture or injury, mal-alignment, muscle weakness, replacement, crystalline arthropathies, or infections of any knee (within last 6 months) or with conditions that mimic knee osteoarthritis symptoms 2.Individuals currently undergoing any therapy for the knee or for whom a surgical treatment is planned during the study period that could affect the condition of the knee (pain, mobility, etc.) 3.Individuals receiving vitamin D3 injections, sulfates, intra-articular corticosteroids, or any other medications that could potentially influence the study outcomes (during the past month) 4.Individuals with any major medical conditions, including but not limited to uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid disorders, coagulopathies, and hepatic or renal dysfunction 5.Individuals with any psychiatric illness and receiving antipsychotic medications 6.Individuals with a recent history of substance abuse 7.Individuals with known use of herbal medications within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 10% decrease in CTX-II levels 2. 10% increase in KOOS score from baseline 3. 10% increase in functional mobility 4. No significant change in the blood safety parameters Timepoint: Day 0, Day 90, Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactPranali Hole
Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be University)
Outcome results
None listed