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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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')
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
研究组 & 干预措施
Loxacon and Physical Therapy
physical therapy(exercise) + caps Loxacon
干预措施: • harpagozid • boswellin = LOXACON (Drug)
Physical therapy and Placebo Loxacon caps
Physical therapy + Placebo caps Loxacon
干预措施: • harpagozid • boswellin = LOXACON (Drug)
Pphysical therapy(alone)
Physical therapy
干预措施: • harpagozid • boswellin = LOXACON (Drug)
结局指标
主要结局
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')
时间窗: "through study completion, an average of 1 year".
pain measurement The higher score the worser
GONIOMETER
时间窗: "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
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: 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).
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: "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
次要结局
- Euroquol Group index EQ-5D-he EQ-5D("through study completion, an average of 1 year".)
研究者
Tamas Bender
professor of Medicine
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest