The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- WOMAC
研究概览
简要总结
This project is to conduct a clinical trial of SYNBIO TECH INC.'s LDL557 capsule for joint protection. To understand the improvement of joint discomfort and inflammation after supplementation, we hope to provide an updated choice for modern people's joint protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 18-40 kg/m2;
- •Those with early stage degenerative arthritis symptoms judged by X-ray to be Kellgren-Lawrence Grading Scale level 1 or 2, and the physician determines that long-term treatment is not needed or WOMAC score>2.0 or WOMAC total scale score>12 or VAS score ≦6.
排除标准
- •alcoholism
- •breastfeeding women and pregnant women.
- •Those consuming dietary supplements were excluded.
- •Those who use non-steroidal anti-inflammatory analgesics and those who have had joint surgery.
- •Rheumatoid arthritis.
- •Those who have had joint injections within 6 months.
- •Those with cardiovascular and cerebrovascular, rheumatoid or mental diseases.
- •Patients undergoing cancer treatment.
研究组 & 干预措施
LDL557-HK capsule
Subjects will take one capsule of the experimental group(LDL557-HK capsule) within 30 minutes before lunch during the experimental period.
干预措施: LDL557-HK capsule (Dietary Supplement)
Placebo capsule
Subjects will take one placebo capsule within 30 minutes before lunch during the experimental period.
干预措施: Placebo Capsule (Dietary Supplement)
结局指标
主要结局
WOMAC
时间窗: Baseline, Week 4, Week 8, and Week 12
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
次要结局
- Inflammation assessment(Baseline and Week 12)
- Thigh circumference(Baseline and Week 12)
- KOOS(Baseline, Week 4, Week 8, and Week 12)
- Lequesne's index(Baseline, Week 4, Week 8, and Week 12)
- VAS(Baseline, Week 4, Week 8, and Week 12)
- Quality of life (QOL) SF-36(Baseline, Week 4, Week 8, and Week 12)
- Kellgren-Lawrence Grade(Baseline and Week 12)
- Joint range of motion assessment(Baseline and Week 12)
- Timed Up and Go Test(Baseline and Week 12)
- Stair Climb Test(Baseline and Week 12)
- Aerobic Capacity(Baseline and Week 12)