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

Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Status and phase: Completed; Phase 4

Conditions: Osteo Arthritis Knee

Treatments: Drug: • harpagozid • boswellin = LOXACON

Study type: Interventional

Funder types: Other

Identifiers

NCT05925725

PolyclinicHBSJG physiothetrapy

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Must be able to swallow tablets

• 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 BodyMassIndex between 25-35.

Exclusion Criteria: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.
• 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.

Clinical diagnosis of Alzheimer's Disease

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups, including a placebo group

Loxacon and Physical Therapy

Active Comparator group

Description:

physical therapy(exercise) + caps Loxacon

Treatment:

Drug: • harpagozid • boswellin = LOXACON

Physical therapy and Placebo Loxacon caps

Placebo Comparator group

Description:

Physical therapy + Placebo caps Loxacon

Treatment:

Drug: • harpagozid • boswellin = LOXACON

Pphysical therapy(alone)

Active Comparator group

Description:

Physical therapy

Treatment:

Drug: • harpagozid • boswellin = LOXACON