Double Blind, Placebo Controlled Trial to Evaluate the Effects of a Nutraceutical Containing High-Molecular-Weight Hyaluronic Acid (HA) and Acetyl-11-Keto-Beta-Boswellic Acid (AKBA) in Patients Affected by Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) results at rest. Change is being assessed.
研究概览
简要总结
Double blind, placebo controlled trial to evaluate the effects of a nutraceutical containing high-molecular-weight hyaluronic acid (HA) and acetyl-11-keto-beta-boswellicacid (AKBA) in patients affected by knee osteoarthritis.
详细描述
The primary objective of the trial is to assess the feasibility of implementing Ultrasonography and Range of Motion (ROM) as objective measurements to correlate the improvement of the knee mobility with the pain reduction of the affected knee in the patients assuming nutraceutical containing hyaluronic acid (HA).
The secondary objectives of the trial are:
- to assess the feasibility of implementing Actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction (optional).
- to evaluate the enrollment rate in one month.
The explorative objectives of the trial are:
• Preliminary data on efficacy of the tested product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender and age from 45 to 70 years
- •Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following ACR criteria with history and physical examination(44). Subjects diagnosed with bilateral knee OA will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period.
- •Available confirmatory X-ray (performed within the previous 6 months) diagnosis (Kellgren/Lawrence score 2) at the evaluated knee joint(45).
- •Subjects experienced pain for at least 15 of the 30 days prior to the start of the study.
排除标准
- •Subjects who have any inflammatory arthritic condition (different from the OA of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder.
- •Treatment with oral corticosteroids within 4 weeks before screening.
- •Intra-articular injections of HA or corticosteroids in the target joint within 3 months before screening.
- •Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection.
- •HA-containing nutritional supplements or cosmetics during the month before the study.
- •Previous surgical treatment of knee joint(s) or its necessity necessity for osteoarthritis (high tibial osteotomy, arthroplasty); complication(s) necessary for hospitalization and surgical treatment.
- •Significant injury to the target joint within the past 6 months prior to screening (identified from medical history).
- •Subjects following an energy-restricted diet for weight loss.
- •Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception.
- •Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
- •Participation in an interventional clinical study in the previous 30 days.
- •Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
研究组 & 干预措施
A: Active comparator SYALOX® 300 Plus
Active Nutraceutical containing HA and AKBA (SYALOX® 300 Plus)
1 tablet/day, oral administration
干预措施: SYALOX® 300 Plus (Dietary Supplement)
B: Placebo
Placebo
1 tablet/day, oral administration
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Visual Analogue Scale (VAS) results at rest. Change is being assessed.
时间窗: week 0, 4 and 16
Change in Visual Analogue Scale (VAS) results at rest, measured in mm
Knee Range of Motion (ROM) results measured by goniometer. Change is being assessed.
时间窗: week 0, 4 and 16
Change in Range of Motion (ROM) results, measured in grades by goniometer.
次要结局
- Knee movement results using an actimeter (accelerometer). Change is being assessed.(week 0 and 16)
- Visual Analogue Scale (VAS) results at moving. Change is being assessed.(week 0, 4 and 16)
- Visual Analogue Scale (VAS) results on pressing. Change is being assessed.(week 0, 4 and 16)
- Ultrasonography parameters results. Change is being assessed.(week 0 and 16)
- Knee injury and Osteoarthritis Outcome Score (KOOS). Change is being assessed.(week 0, 4 and 16)
- Index of Severity for Osteoarthritis of the Knee by Lequesne et al. Change is being assessed.(week 0, 4 and 16)