Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Rhuleave-K: Turmeric Boswellia Extract in Sesamum indicum Seed Oil 500mg single soft gel capsule for 56 days.
Control Intervention1: Placebo: Light Liquid Paraffin
Soft gel 500mg single
Sponsors
Arjuna Natural Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subject aged 40 to 70 years at the time of screening 2.Clinical diagnosis of knee osteoarthritis confirmed by radiography with Kellgren Lawrence grade 1 or 2 (AP view X-ray at screening). 3.Knee pain on movement with a VAS score greater than or equal to 50 mm at screening 4.Baseline WOMAC score meeting all of the following: Pain subscale: score greater than or equal to 2 in at least two activities Stiffness subscale: score greater than or equal to 1 in at least one activity Physical function subscale: total score greater than or equal to 10 5.Body Mass Index (BMI) between 18 to 29 kg per m , inclusive 6.Willingness to maintain usual lifestyle habits and refrain from initiating new pain- or joint-related supplements during the study. 7.Ability and willingness to comply with all protocol-required procedures and visit schedules. 8.Provision of written informed consent prior to initiation of any trial-specific procedures.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of moderate or severe knee osteoarthritis (Kellgren Lawrence grade greater than or equal to 3). 2.History of rheumatoid arthritis, gout, inflammatory arthritis diagnosed according to the (American College of Rheumatology (ACR), fibromyalgia, or other non-osteoarthritic joint disorders. 3.History of knee surgery, hip replacement surgery, meniscal rupture, or planned knee surgery during the study period. 4.Presence of significant underlying back pain that may confound assessment of knee pain. 5.BMI greater than or equal to 30 kg per m 6. High alcohol intake (greater than 2 standard drinks per day) 7.Smoking status not more than 1 pack per day. 8.Use of any of the following within the specified washout periods prior to screening Glucosamine sulphate, chondroitin sulphate, intra-articular hyaluronate, or systemic or intra-articular corticosteroids within 3 months. NSAIDs, anti-inflammatory drugs, boswellia, curcumin, omega-3 fatty acids, collagen supplements, or topical analgesics within 30 days. 9.Use of antibiotics, NSAIDs, steroids, or over-the-counter pain medications within 1 week prior to screening 10.Significant comorbid illness (e.g., cardiovascular, endocrine, renal, or other chronic disease) that may interfere with study participation or outcome interpretation 11.History of substance abuse, including psychedelic or narcotic drug use 12.Psychiatric illness (e.g., schizophrenia) or use of psychotropic medications that may interfere with study compliance. 13.Pregnant, breastfeeding, or planning pregnancy during the study period. 14. Participation in another clinical trial within 3 months prior to screening. 15.Any condition which, in the opinion of the Investigator, would make participation unsafe or compromise data integrity. 16.Subjects with a history of allergy or adverse reactions to the investigational product. 17.Subjects with hip or lower back pain that could interfere with walking or exercise assessments performed during the study. 18.Unwillingness or inability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC total score from baseline to end of the studyTimepoint: Baseline, Days 1,3,5,7,28,56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain relief using VAS from baseline to end of the studyTimepoint: Baseline, Days 1,3,5,7,28,56;Change in Functional performance tests like 9-step stair negotiation 30-second chair stand test 6-minute walk test from baseline to end of study. Timepoint: Baseline, Days 1,3,5,7,28,56 | — |
Countries
India
Contacts
Public ContactSooraj Rajasekharan Kartha
Arjuna Natural Pvt. Ltd
Outcome results
None listed