Medium Chain Triglyceride solution
Placebo
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-07-02
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This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Placebo
Group 2: Cannabis sativa extract with CBD (45mg/day).
Eligibility
primary outcomes
Time frame: 2 months
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.
secondary outcomes
Time frame: 2 months
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.
Time frame: 2 months
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.
Time frame: 2 months
presence of adverse events (AE) - proportion of patients with AE in the placebo and intervention groups;
Time frame: 2 months
presence of serious adverse events (AEs) - description of the serious AEs that may appear in each group.
Time frame: 2 months
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: * Good 0-4 * Bad -10 * Presence of sleep disturbance greater than 10
Time frame: 2 months
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.
Time frame: 2 month
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
Time frame: 2 month
Used to monitor liver function in patients, as pacientes are receiving an oil-based medication that may overload the liver.
Publications