Osteo Arthritis Knee
Conditions
Keywords
Boswellia serrata,, Harpagophytum procumbens,, knee OA
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 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.
Interventions
DRUG• harpagozid • boswellin = LOXACON
Exercise therapy
Sponsors
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | one year | 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') | through study completion, an average of 1 year. | pain measurement The higher score the worser |
| GONIOMETER | through study completion, an average of 1 year. | 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) | through study completion, an average of 1 year. | 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
| Measure | Time frame | Description |
|---|---|---|
| Euroquol Group index EQ-5D-he EQ-5D | through study completion, an average of 1 year. | 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). |
Countries
Hungary
Outcome results
None listed