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

NCT ID: NCT05925725

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2023-09-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Loxacon and Physical Therapy

physical therapy(exercise) + caps Loxacon

Group Type: ACTIVE_COMPARATOR

• harpagozid • boswellin = LOXACON

Intervention Type: DRUG

Exercise therapy

Physical therapy and Placebo Loxacon caps

Physical therapy + Placebo caps Loxacon

Group Type: PLACEBO_COMPARATOR

• harpagozid • boswellin = LOXACON

Intervention Type: DRUG

Exercise therapy

Pphysical therapy(alone)

Physical therapy

Group Type: ACTIVE_COMPARATOR

• harpagozid • boswellin = LOXACON

Intervention Type: DRUG

Exercise therapy

Interventions

• harpagozid • boswellin = LOXACON

Exercise therapy

Intervention Type: DRUG

Other Intervention Names

Physiotherapy(exercise)

Eligibility Criteria

Inclusion Criteria

• 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

• 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

-

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Tamas Bender

professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zoltán Dégi, M.D

Role: STUDY_DIRECTOR

Goodwill Pharma

Zoltán Dégi

Role: STUDY_CHAIR

Goodwill Pharma

Tamas Bender

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Lakitelek foundation

Lakitelek, , Hungary

Countries

Hungary

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PolyclinicHBSJG physiothetrapy

Identifier Type: -

Identifier Source: org_study_id