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
Phase: PHASE4
Conditions: Osteo Arthritis Knee
Sponsor: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Study protoco 
 
Introduction 
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 / 21-21 per clinic 
(with 7 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 takes place according to a uniform protocol. 
Physiotherapy 2x30 minutes per week for 5 weeks (10 times in total). 
The course of the investigation 
1st visit: selection, filling in questionnaires 
2nd visit: after the 10th exercise session, while taking Loxacon/placebo, filling in questionnaires 
3rd 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 test 
▪ EQ-5D-5L quality of life test 
▪ Goniometer angle measurement(ROM) 
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. 
 
2 
 
Pain reliever use 
If it is necessary to take painkillers, paracetamol can be used uniformly, which 
is recorded. 
The primary research objective: 
How does Loxacon - as a dietary supplement - capsule work in osteoarthritis of the knee joint 
on the pain and function of patients with 
The secondary research objective: 
How Loxacon capsules work for patients with knee osteoarthritis 
quality of life? 
SELECTION CRITERIA 
1. According to the ACR (American College of Rheumatology) knee arthrosis criteria, 
knee arthrosis supported by an imaging procedure (comparative knee X-ray). Both 
in the case of knee involvement, the more complaining knee will be examined! 
2. A patient reporting knee pain characteristic of knee arthrosis for at least 3 months, where the VAS 
value 40-70 mm. 
3. With a diagnosis of mild and moderate knee arthrosis. 
4. Male or female patients between the ages of 40 and 80. 
5. With a BMI between 25-35. 
EXCLUSION CRITERIA 
• Intra-articular corticosteroid within 3 months before starting treatment 
injection. 
• Intra-articular hyaluronic acid treatment within 6 months or such treatment during the 
examination 

treatment. 
• Physiotherapy treatment received within 3 months prior to the start of the treatment. 
• NSAID changed within 3 months prior to treatment or during treatment, or 
chondroprotective treatment. 
• In inflammatory rheumatological diseases (RA, SPA, APs, crystal arthropathies, etc.) 
suffering patient. 
• Knee surgery within 6 months prior to the examination. 
• Presence of a metal implant in the knee joint. 
• Any patient with a knee fracture. 
• Patients who had a knee joint injury within 6 months prior to the examination. 
• Patients with a palpable fluid collection in the knee or Baker's cyst. 
• Uncooperative patients, patients with inadequate mental or psychological status.