NCT05925725

Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at Patients With Knee Arthrosis

Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at the Treatment of Patients With Knee Arthrosis. A Multicenter Randomized, Double-blind, Follow-up Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study will be a multicenter, randomized, double-blind, follow-up clinical trial. Neither the examining doctor nor the patient knows which capsule they will receive. Just the test unlock the codes after completion. T

Detailed description

The study will be a multicenter, randomized, double-blind, follow-up clinical trial. Neither the examining doctor nor the patient knows which capsule they will receive. Just the test unlock the codes after completion. The randomization was performed externally, not included in the study performed by a person. Number of patients: a total of 105 patients / 25-25 per clinic (with 8 patients each in three treatment groups) Three treatment groups * 35 people physical therapy + Loxacon * 35 main physical therapy + Placebo * 35 people only for physical therapy Physiotherapy(exercise) takes place according to a uniform protocol. Physiotherapy 2x30 minutes per week for 5 weeks (10 times in total). The course of the investigation 1. st visit: selection, filling in questionnaires 2. nd visit: after the 10th exercise session, while taking Loxacon/placebo, filling in questionnaires 3. rd visit: Uniformly after another 2 months of taking Loxacon, in all three groups, completing questionnaires After the first 5 weeks, all three branches will receive enough Loxacon capsules for 2 months! The parameters to be tested * WOMAC test * VAS * EQ-5D-5L quality of life test * Goniometer angle measurement The test is completed by patients who participated in more than 70% of the treatment! Monitoring of side effects It is the duty of the doctor of the given center - who reports to the investigator.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
DRUG	• harpagozid • boswellin = LOXACON	Exercise therapy

Timeline

• Start date: 2023-01-25
• Primary completion: 2023-05-05
• Completion: 2023-09-06
• First posted: 2023-06-29
• Last updated: 2023-11-15

Locations

1 site across 1 country: Hungary