Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Osteoarthritis (OA) is the most prevalent joint disease in humans, often causing disability in affected individuals, especially the elderly. OA is characterized by mechanical joint pain, crepitus and short-term post-immobilization stiffness. OA pain has a variable pathophysiology and, despite the many pharmacological options available, its treatment is often ineffective and has significant side effects. The search for more effective and safer treatments is therefore essential in the field of OA. Among the possible treatments are substances derived from cannabis. Cannabis plants have been used for various purposes by humankind for thousands of years. Its best-known species, Cannabis sativa, has more than a hundred substances called cannabinoids or, more specifically, phytocannabinoids, the most important of which is cannabidiol (CBD). Although many pre-clinical studies indicate the usefulness of phytocannabinoids, clinical evidence for their application is currently scarce. Therefore, this project aims to investigate the effects of a CBD-rich extract of Cannabis sativa on the pain of patients with knee OA, as well as the possible adverse events of this treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | placebo (solution of Medium Chain Triglycerides, without any active ingredient) |
|
| Group 2 | Experimental | Cannabis sativa extract with a CBD (45 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium Chain Triglyceride solution | Dietary Supplement | Placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain levels | Change in pain levels, according to the score in the "pain" domain of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), using the Likert scale to assign a value to the answers obtained from the participants. The pain levels according to the score are 0-8 mild, greater than 8-14 moderate, greater than 14- 20 high. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Health Survey (SF-12) | Change in the Short Form Health Survey (SF-12) quality of life scores, according to the "maximal walking" and "activities of daily living" domains, where a score of 0 is the worst quality of life and 100 the best. | 2 months |
| Depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francisney P Nascimento, 1 | Federal University of Latin American Integration | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Latin American Integration | Foz do Iguaçu | Paraná | 85870-650 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41487518 | Derived | Mojoli A, Haider O, Fakih Y, Luz Goncalves MV, Zepeda Rojas B, Xaia G, Krefta E, Bicca MA, Lopes de Mari T, Ferreira CF, Cezar-Dos-Santos F, Toci AT, Nascimento FP. Effects and safety of a CBD-rich Cannabis sativa oil in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial - CANOA - cannabis for osteoarthritis. Front Pharmacol. 2025 Dec 19;16:1657065. doi: 10.3389/fphar.2025.1657065. eCollection 2025. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cannabis Sativa |
| Other |
Group 2: Cannabis sativa extract with CBD (45mg/day). |
|
Changes in levels of depression using the Beck Depression scale. Changes in depression levels using the Beck depression scale. The disease level values range from 0-9 indicating that the individual is not depressed, 10-18 indicating mild to moderate depression, 19-29 indicating moderate to severe depression and 30-63 indicating severe depression. |
| 2 months |
| Adverse events | presence of adverse events (AE) - proportion of patients with AE in the placebo and intervention groups; | 2 months |
| Serious adverse events | presence of serious adverse events (AEs) - description of the serious AEs that may appear in each group. | 2 months |
| Change in sleep quality | The Pittsburgh scale was used to see if there was any change in the participants' quality of sleep. The scale used classifies sleep quality as follows:
| 2 months |
| Renal Function Panel | Used as form to identify any renal impairment in pacientes that could result in any need of adjusting the dose or need to leave the study. | 2 months |
| Visual Analogue Scale (VAS) | It is used in the healthcare field to measure the intensity of pain a person feels, usually on a scale from 0 to 10, where 0 means 'no pain' and 10 means 'the worst pain imaginable | 2 month |
| Hepatic Panel | Used to monitor liver function in patients, as pacientes are receiving an oil-based medication that may overload the liver. | 2 month |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C587251 | nabiximols |
Not provided
Not provided
Not provided