Clinical trial
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
Name
PolyclinicHBSJG physiothetrapy
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. T
Trial arms
Trial start
2023-01-25
Estimated PCD
2023-05-05
Trial end
2023-09-06
Status
Completed
Phase
Early phase I
Treatment
• harpagozid • boswellin = LOXACON
Exercise therapy
Arms:
Loxacon and Physical Therapy, Physical therapy and Placebo Loxacon caps, Pphysical therapy(alone)
Other names:
Physiotherapy(exercise)
Size
100
Primary endpoint
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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')
"through study completion, an average of 1 year".
GONIOMETER
"through study completion, an average of 1 year".
Knee Injury and Osteoarthritis Outcome Score (KOOS)
"through study completion, an average of 1 year".
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
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Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-11-15
1 organization
1 product
1 indication
Product
Harpagozid + BoswellinIndication
Osteoarthritis of the Knee