Status:
COMPLETED
Analgesic Effects of a Treatment With Cannabis Sativa Extract in Patients With Knee Osteoarthritis - CANOA (Cannabis for Osteoarthritis)
Lead Sponsor:
Federal University of Latin American Integration
Conditions:
OSTEOARTHRITIS OF THE KNEE
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Have a diagnosis of knee osteoarthritis, according to the ACR classification criteria (ALTMAN, 1986);
- Have a moderate or high level of pain induced by osteoarthritis (visual analog scale scale equal to or greater than 5);
- Voluntarily agree to take part in the study by signing the Informed Consent Form (ICF);
- For women of reproductive age, a negative Beta-HCG test, and use of a contraceptive method throughout the study.
- For women of reproductive age, a negative Beta-HCG test, and use of a contraceptive method throughout the study and 3 months after its conclusion.
- Age range of thirty (30) to seventy (70) years.
Exclusion
- People with heart failure, hypertension or any heart disease;
- People with chronic kidney disease or liver failure;
- Patients with chronic inflammatory diseases;
- Patients with severe psychiatric illnesses, such as severe mood disorders and psychotic disorders;
- Current use of cannabinoids by any route of administration.
- Pregnant women
- Lactating women
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06588972
Start Date
January 1 2024
End Date
October 12 2024
Last Update
July 2 2025
Active Locations (1)
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1
Federal University of Latin American Integration
Foz do Iguaçu, Paraná, Brazil, 85870-650