None listed
Conditions
Interventions
Intervention1:
BBETTER OrthoUrja Capsule 650 mg
: One capsule after breakfast and dinner (twice daily) with ambient temperature water for 8 weeks.
Control Intervention1: Placebo Capsule: One capsule
Sponsors
MONKSAYS SUPERFOODS PVT. LYD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged 30 to 70 years. 2. Mild to moderate knee/joint pain (VAS score 3 to 7). 3. Diagnosis of mild to moderate osteoarthritis (Kellgren-Lawrence Grade 1 to 3). 4. Pain duration of at least 3 months. 5. BMI between 18.5 and 30 kg/m . 6. Ambulatory and capable of performing basic physical activities. 7. Willingness to discontinue other joint health supplements or anti-inflammatory medications (except rescue acetaminophen). 8. No significant comorbidities or surgeries in the past 6 months.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in knee pain intensity using the Visual Analog Scale (VAS) from baseline.Timepoint: Baseline, Week 4, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Timed Up and Go Test (TUG- Functional test assessing the time taken to rise from a chair, walk a short distance, and return) from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Numeric Pain Rating Scale (NPRS) score from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Short Form-12 (SF-12) for Quality of Life score from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Inflammatory Biomarkers (IL-6, TNF-a, CRP) from baseline.Timepoint: Baseline, Week 8;Change in Cartilage and Joint Health Biomarkers (Cartilage Oligomeric Matrix Protein (COMP) and other factors) from baseline.Timepoint: Baseline, Week 8;Change in Treatment-Emergent Adverse Events (TEAEs) from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Treatment-Emergent Serious Adverse Events (TESAE) from baseline.Timepoint: Baseline, Week 4, Week 8 | — |
Countries
India
Contacts
Public ContactDr Sanjeev Kumar Kare
Government Medical College & Govt. General Hospital
Outcome results
None listed