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

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

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

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Drug: • harpagozid • boswellin = LOXACON

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Lakitelek, Hungary
    • Lakitelek foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Loxacon and Physical Therapy; physical therapy(exercise) + caps Loxacon	Drug: • harpagozid • boswellin = LOXACON; Exercise therapy; Other Names: Physiotherapy(exercise)
Placebo Comparator: Physical therapy and Placebo Loxacon caps; Physical therapy + Placebo caps Loxacon	Drug: • harpagozid • boswellin = LOXACON; Exercise therapy; Other Names: Physiotherapy(exercise)
Active Comparator: Pphysical therapy(alone); Physical therapy	Drug: • harpagozid • boswellin = LOXACON; Exercise therapy; Other Names: Physiotherapy(exercise)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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".
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".
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".

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".

Collaborators and Investigators

• Sponsor: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
• Investigators: Study Director: Zoltán Dégi, M.D, Goodwill Pharma; Study Chair: Zoltán Dégi, Goodwill Pharma; Principal Investigator: Tamas Bender, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: knee OA; Boswellia serrata,; Harpagophytum procumbens,
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PolyclinicHBSJG physiothetrapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No