Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Cannabidiol: oral Cannabidiol syrup - 5ml twice daily for 3 months , after food , to be taken orally
Control Intervention1: Olive oil: Olive oil infused placebo - 5 ml twice daily for 3
Sponsors
Unique Therepeutics
Eligibility
Inclusion criteria
Inclusion criteria: Male or female with age of 18-65 years. Subjects diagnosed with moderate to severe osteoarthritis with symptoms of pain and swelling, tenderness, morning stiffness, of one or more joint continuously for more than 3 weeks. Subjects suffering from chronic pain with a baseline pain intensity of 6 or above on a 10-cm visual analog scale (VAS). Patients receiving any other local medication for symptomatic management of pain can be included after a wash out period of 7 days. Willing to give written informed consent.
Exclusion criteria
Exclusion criteria: Subjects with abnormal hematologic function (Hemoglobin 8gm/dl, WBC count 3000/mm3, platelet count 100,000/mm3). Subjects with present known or signs of serious spinal pathology (i.e., cauda equine syndrome, trauma, fractures, or cancer); history of abdominal, lumbar, or lower limb surgery in the past year; rheumatologic disease in the acute inflammatory phase. History of any deformities or any wound in the affected area. Any concomitant serious disorders like hepatic dysfunction, chronic kidney disease, cardiovascular diseases, pulmonary disease, and use of chemotherapy agents or history of cancer. A history of psychiatric disorders that may interfere with study participation or affect the ability to comply with the protocol requirements. Gravid women and lactating mother. Heavy smoker, Chronic alcoholic, or drug abuse subjects Known cases of malignancy, HIV infection, AIDS, etc. Subject who participated in any other clinical investigation using an experimental drug or has donated blood . Participants are not willing to sign the ICF and to attend the treatment schedule regularly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in joint pain and inflammation severity (efficacy of CBD) using WOMAC or equivalent scale. Comparative improvement in pain, stiffness, and function between CBD and placebo groupsTimepoint: To assess the reduction in joint pain and inflammation severity using the WOMAC score and Visual analogue scale from Day 1 (baseline) to Day 90 (End of study). To compare the improvement in pain, stiffness, and function between interventional and placebo groups from Day 1 (baseline) to Day 90 (End of study). | — |
Secondary
| Measure | Time frame |
|---|---|
| The study aims to evaluate the safety and tolerability of CBD through the assessment of adverse events and laboratory parameters. In addition, it will assess the efficacy of CBD on osteoarthritis symptoms by observing changes in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, which measures pain, stiffness, and physical function.Timepoint: Assessments will be conducted at baseline (Week 0) before starting treatment and at the endpoint (Week 12). Optional interim evaluations for safety and laboratory monitoring will also be performed at Weeks 4 and 8. | — |
Countries
India
Contacts
Public ContactMothish waran B
Interdisciplinary Institute of Indian System of Medicine
Outcome results
None listed