NCT05683327已完成不适用
The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function: A Randomized-Blind, Placebo-Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12
研究概览
简要总结
This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.
详细描述
In this study, the investigators will evaluate the knee condition before and after the intervention. The groups to be compared are two different doses of UltraHA® and a placebo.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •Healthy subjects
- •Subjects whose skin viscoelasticity is relatively low at screening (before consumption)
- •Subjects whose BMI are 23 kg/m^2 or more and less than 30 kg/m^2
- •Subjects who are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in X-ray
- •Subjects whose WOMAC score is relatively high
排除标准
- •Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
- •Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
- •Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- •Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
- •Subjects who consciously consume foods that contribute to knee joint improvements, such as collagen and chondroitin sulfate
- •Subjects who are currently taking medications (including herbal medicines) and supplements
- •Subjects who are allergic to medications and/or the test-food-related products (particularly alcohol)
- •Subjects who are pregnant, lactating, or planning to become pregnant during this trial
- •Subjects who suffer from COVID-19
- •Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
- •Subjects who are judged as ineligible to participate in this study by the physician
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12
时间窗: Week 12
The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of responses is evaluated as the WOMAC scores.
次要结局
- Each WOMAC subscale score at Week 12(Week 12)
- Subjective symptoms at Week 12(Week 12)
研究者
研究点 (4)
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