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

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Primary Purpose

Status

Active

Phase

Phase 4

Locations

Hungary

Study Type

Interventional

Intervention

• harpagozid • boswellin = LOXACON

About this trial

This is an interventional health services research trial for Osteo Arthritis Knee focused on measuring Boswellia serrata,, Harpagophytum procumbens,, knee OA

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

Lakitelek foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Loxacon and Physical Therapy

Physical therapy and Placebo Loxacon caps

Pphysical therapy(alone)

Arm Description

physical therapy(exercise) + caps Loxacon

Physical therapy + Placebo caps Loxacon

Physical therapy

Outcomes

Primary Outcome Measures

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).

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

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

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

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT05925725

First Posted

April 7, 2023

Last Updated

June 29, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05925725

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 25, 2023 (Actual)

Primary Completion Date

May 5, 2023 (Actual)

Study Completion Date

September 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteo Arthritis Knee

Keywords

Boswellia serrata,, Harpagophytum procumbens,, knee OA

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Loxacon and Physical Therapy

Arm Type

Active Comparator

Arm Description

physical therapy(exercise) + caps Loxacon

Arm Title

Physical therapy and Placebo Loxacon caps

Arm Type

Placebo Comparator

Arm Description

Physical therapy + Placebo caps Loxacon

Arm Title

Pphysical therapy(alone)

Arm Type

Active Comparator

Arm Description

Physical therapy

Intervention Type

Drug

Intervention Name(s)

• harpagozid • boswellin = LOXACON

Other Intervention Name(s)

Physiotherapy(exercise)

Intervention Description

Exercise therapy

Primary Outcome Measure Information:

Title

Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Description

The test questions are scored on a scale of 0-4, whichcorrespondto: None (0), Mild (1) , Moderate (2), Severe (3), and Extreme (4).

Time Frame

one year

Title

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')

Description

pain measurement The higher score the worser

Time Frame

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

Title

GONIOMETER

Description

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

Time Frame

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

Title

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zoltán Dégi, M.D

Organizational Affiliation

Goodwill Pharma

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zoltán Dégi

Organizational Affiliation

Goodwill Pharma

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tamas Bender

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lakitelek foundation

City

Lakitelek

Country

Hungary

12. IPD Sharing Statement

Plan to Share IPD

No

Osteo Arthritis Knee

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial