Clinical trial NCT05925725: Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at Patients With Knee Arthrosis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteo Arthritis Knee
Keywords: Boswellia serrata,
Harpagophytum procumbens,
knee OA
Lead sponsor: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

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Primary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: one year
measure: 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')
timeFrame: "through study completion, an average of 1 year".
measure: GONIOMETER
timeFrame: "through study completion, an average of 1 year".
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: "through study completion, an average of 1 year".
Secondary outcomes:
measure: Euroquol Group index EQ-5D-he EQ-5D
timeFrame: "through study completion, an average of 1 year".
Other outcomes:
Locations:
city: Lakitelek
country: Hungary
facility: Lakitelek foundation
Study officials:
affiliation: Goodwill Pharma
name: Zoltán Dégi, M.D
role: STUDY_DIRECTOR
affiliation: Goodwill Pharma
name: Zoltán Dégi
role: STUDY_CHAIR
affiliation: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
name: Tamas Bender
role: PRINCIPAL_INVESTIGATOR
References: