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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loxacon and Physical Therapy | Active Comparator | physical therapy(exercise) + caps Loxacon |
|
| Physical therapy and Placebo Loxacon caps | Placebo Comparator | Physical therapy + Placebo caps Loxacon |
|
| Pphysical therapy(alone) | Active Comparator | Physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| • harpagozid • boswellin = LOXACON | Drug | Exercise therapy |
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| 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". |
| 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". |
| 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". |
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Inclusion Criteria Must be able to swallow tablets
Exclusion Criteria:EXCLUSION CRITERIA
Clinical diagnosis of Alzheimer's Disease
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakitelek foundation | Lakitelek | Hungary |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2023 | Apr 6, 2023 | Prot_000.pdf |
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