Health Condition 1: M255- Pain in joint
Conditions
Interventions
None listed
Sponsors
Planet Ayurveda Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age between 40 and 70 years (inclusive), of either sex. 2.Written informed consent obtained voluntarily prior to initiation of study-related procedures. 3.Clinical diagnosis of unilateral or bilateral knee osteoarthritis for more than 3 months, as determined by a physician based on clinical symptoms and physical examination. 4.Willingness and ability to comply with all scheduled visits, treatment regimen, study procedures, and completion of questionnaires (WOMAC, VAS, SF-36). 5.Stable general health condition with no major planned changes to existing medications during the study period.
Exclusion criteria
Exclusion criteria: 1.History of knee or hip joint replacement surgery, or significant hip or lower back pain that interferes with ambulation or could confound study assessments. 2.Anticipated requirement for orthopedic surgery during the 90 days treatment period. 3.Pregnant or lactating women, or women planning to conceive during the study period. 4.Participation in another clinical trial or use of any investigational drug within 30 days prior to screening. 5.Uncontrolled diabetes mellitus, defined as fasting blood glucose greater than 140 mg per dL or HbA1c greater than 7.5 percentage at last available assessment. 6.Chronic respiratory illnesses such as chronic obstructive pulmonary disease (COPD), or history of breathing disorders that may impact physical activity tolerance. 7.Current or recent (within 6 months) use of immunosuppressive medications, or diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, lupus). 8.Known allergy or hypersensitivity to Boswellia, curcumin, or any herbal ingredients in the investigational products. 9.Any other medical or psychiatric condition which, in the opinion of the investigator, may compromise Subject Safety or interfere with the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total WOMAC score from Baseline to Day 30 ± 3, Day 60 ± 3, and Day 90 ± 3 days. WOMAC assesses pain, stiffness, and physical function. Total score: 0â??96 (higher = worse symptoms). Primary efficacy is the reduction in total WOMAC score from Baseline to Day 90 ± 3 days. Timepoint: Day 0, Day 30 ±3 days, Day 60 ±3 days, Day 90 ±3 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Visual Analogue Scale (VAS) Score for Joint Pain 2.Change in Quality of Life Score as measured by SF-36 from Baseline to Day 90 3.Incidence and Nature of Adverse Events (AEs) 4.Physical Examination and Vital Signs MonitoringTimepoint: Day 0, Day 30 ±3 days, Day 60 ±3 days, Day 90 ±3 days | — |
Countries
India
Contacts
Public ContactDr. Vikram Chauhan
Planet Ayurveda Private Limited
Outcome results
None listed