JPRN-jRCT1030230376进行中（未招募）Unknown
Effects of consumption of the test food on the knee joint in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Takara Tsuyoshi0 个研究点目标入组 68 人开始时间: 2023年9月30日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Japanese
- •2. Men or women
- •4. Healthy subjects
- •5. Subjects who have agreed to participate and are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption; Scr)
- •6. The top 68 subjects with high Japanese Knee Osteoarthritis Measure (JKOM) score at Scr among those who have agreed to participate and meet inclusion criteria No.1~5 and 7 without meeting any of exclusion criteria
- •7. Subjects who are judged as eligible to participate in the study by the physician
排除标准
- •1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, or any other heart disease
- •2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
- •3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatoid arthritis, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- •4. Subjects who use or take Foods for Specified Health Uses, or Foods with Functional Claims
- •5. Subjects who are taking medications (including herbal medicines) and supplements
- •6. Subjects who are allergic to medicines and/or the test food related products
- •7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
- •8. 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
- •9. Subjects who usually use Foods for Specified Health Uses, or Foods with Functional Claims that affect the knee joint {e.g. N-acetylglucosamine, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide}
- •10. Subjects who engage in strenuous physical activity {e.g. ball sports (such as soccer, baseball, basketball), jogging, running, skiing, snowboarding} that places a load on the joints
- •11. Subjects who use a cane or joint support, or may use them during this trial
- •12. Subjects who are judged as ineligible to participate in this study by the physician
研究者
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