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

NCT05925725 | Completed Phase 4

• 1 other identifier: PolyclinicHBSJG physiothetrapy
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Osteo Arthritis Knee

Keywords

Boswellia serrata,; Harpagophytum procumbens,; knee OA

Outcome Measures

Primary Outcomes (4)

• 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".

• 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".

• 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 Outcomes (1)

• Euroquol Group index EQ-5D-he EQ-5D

  "through study completion, an average of 1 year".

Study Arms (3)

Loxacon and Physical Therapy

ACTIVE COMPARATOR

physical therapy(exercise) + caps Loxacon

Drug: • harpagozid • boswellin = LOXACON

Physical therapy and Placebo Loxacon caps

PLACEBO COMPARATOR

Physical therapy + Placebo caps Loxacon

Drug: • harpagozid • boswellin = LOXACON

Pphysical therapy(alone)

ACTIVE COMPARATOR

Physical therapy

Drug: • harpagozid • boswellin = LOXACON

Interventions

• harpagozid • boswellin = LOXACON DRUG

Exercise therapy

Also known as: Physiotherapy(exercise)

Loxacon and Physical Therapy; Physical therapy and Placebo Loxacon caps; Pphysical therapy(alone)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Polyclinic of the Hospitaller Brothers of St. John of God, Budapest: lead

Study Sites (1)

Lakitelek foundation

Lakitelek, Hungary

Location

Study Officials

• Zoltán Dégi, M.D

  Goodwill Pharma

  STUDY DIRECTOR

• Zoltán Dégi

  Goodwill Pharma

  STUDY CHAIR

• Tamas Bender

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Medicine

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: June 29, 2023
• Study Start: January 25, 2023
• Primary Completion: May 5, 2023
• Study Completion: September 6, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)