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

Osteo Arthritis Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05925725
• Other study ID #: PolyclinicHBSJG physiothetrapy
• Status: Completed
• Phase: Phase 4
• Start date: January 25, 2023
• Est. completion date: September 6, 2023

Study information

• Verified date: November 2023
• Source: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 6, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• • harpagozid • boswellin = LOXACON
Exercise therapy

Locations

Country	Name	City	State
Hungary	Lakitelek foundation	Lakitelek

Sponsors (1)

Lead Sponsor	Collaborator
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	The test questions are scored on a scale of 0-4, whichcorrespondto: None (0), Mild (1); , Moderate (2), Severe (3), and Extreme (4).	one year
Primary	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')	pain measurement The higher score the worser	"through study completion, an average of 1 year".
Primary	GONIOMETER	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	"through study completion, an average of 1 year".
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	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	"through study completion, an average of 1 year".
Secondary	Euroquol Group index EQ-5D-he EQ-5D	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).	"through study completion, an average of 1 year".