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Completed

NCT Number: NCT05925725

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

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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lakitelek foundation

Lakitelek, Hungary

About this study

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
  • st visit: selection, filling in questionnaires
  • nd visit: after the 10th exercise session, while taking Loxacon/placebo, filling in questionnaires
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

• harpagozid • boswellin = LOXACON

Drug

Exercise therapy

Other names: Physiotherapy(exercise)

Primary outcomes

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: one year

    The test questions are scored on a scale of 0-4, whichcorrespondto: None (0), Mild (1)

    , Moderate (2), Severe (3), and Extreme (4).

  2. Visual analog The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

    Time frame: "through study completion, an average of 1 year".

    pain measurement The higher score the worser

  3. GONIOMETER

    Time frame: "through study completion, an average of 1 year".

    Range of motion(0-140)Goniometry is the art and science of measuring the joint ranges in each plane of the joint.The hihger the movements's degree the better the result of exercise

  4. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: "through study completion, an average of 1 year".

    The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, otherSymptoms, Function in dailyliving (ADL), Function in Sport and Recreation (Sport/Rec), and knee-relatedQuality of Life (QOL)KOOS consists of 5 subscales; long-term patient-relevant outcomes following knee injury

Secondary outcomes

  1. Euroquol Group index EQ-5D-he EQ-5D

    Time frame: "through study completion, an average of 1 year".

    is a commonly used general questionnaire belonging to the first group. When filling it out, respondents in 5 dimensions: mobility, self-sufficiency, usual activities, pain/discomfort, anxiety/depression; They can choose from 3 levels (1: least, 3: most).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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