To Investigate the Efficacy and Mechanism of ZBP Powder Product in the Treatment of Osteopenia in Patients With Pain.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pain on the visual-analogue scales (VAS) for back and legs.
研究概览
简要总结
This study investigates the efficacy and mechanism of traditional Chinese medicine formula power product in the treatment of osteopenia in patients with pain. Half of participants will receive Chinese medicine formula power product, while the other half will receive a placebo.
详细描述
Osteoporosis is a major public health problem, resulting in potentially pain and increasing risk of fracture. Treatment of osteoporosis consists of pharmacotherapy, lifestyle measures, dietary changes, mineral supplementation. Traditional Chinese medicine is a major component of health care in Taiwan and provides one treatment alternative for osteoporosis.
Investigators investigate the efficacy and mechanism of traditional Chinese medicine formula powder product in the treatment of osteopenia patients with pain.This trial is a 12 weeks' randomized, placebo-controlled study. The study was approved by the Wan Fang hospital, and signed informed consent was obtained from each participant. 80 Osteopenia participants with pain were enrolled in this study. There were 80 participants aged 50 years or older included. Before random assignment to treatment, participants were at least moderate pain during 2 weeks as identified by visual analogue scale (VAS) for more than 4. Bone mineral density (BMD) of all participants was -2.5 or below without diabetes, hyperthyroidism, hypoparathyroidism, liver or kidney function disorder, ovariectomy, rheumatoid arthritis, bone cancer, ever used hormone agent within 6 months before assignment to treatment, ever used steroids more than 3 week before assignment to treatment, Primary outcome measures were the change of VAS scale, Oswestry Disability Index and WHOQOL-BREF Taiwan at week 1 and 12. Secondary outcome was the genetic loci associated with a susceptibility to osteoprosis treated by traditional Chinese medicine formula powder product.
Result : To provide evidence of the efficacy and mechanisms of ZBP powder product in the treatment of osteoporosis patients with pain.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 50 years or older.
- •VAS score≧4.0 in a week.
- •bone mineral density (BMD) of all participants was -2.5 or below.
排除标准
- •thyroidism function disorder.
- •parathyroidism function disorder.
- •liver or kidney function disorder.
- •ovariectomy
- •rheumatoid arthritis.
- •bone cancer.
- •ever used hormone agent within 6 months before assignment to treatment.
- •ever used steroids more than 3 months before assignment to treatment.
- •ever used analgesics, excepted acetaminophen, more than 1 week before assignment to treatment.
结局指标
主要结局
Pain on the visual-analogue scales (VAS) for back and legs.
时间窗: baseline and week 12
A VAS is a 100-mm-long horizontal line that is anchored by word descriptors at each end (no pain and worst pain possible). The patient selects the point on the line that best represents his or her perception of their pain level.
次要结局
未报告次要终点