A Randomized, Single Center, Double Blind, Parallel, Placebo-controlled Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 166
- 主要终点
- The change of T-score of bone mineral density(QCT)
研究概览
简要总结
A randomized, single center, double blind, parallel, placebo-controlled, clinical study of efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the improvement of osteoporosis and symptoms in Women's older than 50 patients with osteoporosis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female more than 50 years old in osteoporosis
排除标准
- •Wash out peroid: using agents more than 3 months against osteoporosis
- •Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)
- •Subject who has a chronic liver disease, thyroid disease and chronic renal disease
- •Subject who is chronic alcoholics and undernourished
- •Other conditions were not suitable in study : Severe physical defects mental defects
- •Pregnant woman
- •Subject who is not calibrated hypercalcemia/hypocalcemia
- •Secondary osteoporosis : Subject who takes drugs(Glucocorticoid, Diabetes Medications)
- •Subject who has 60% more fracture risk in FRAX(WHO fracture risk assessment tool)
研究组 & 干预措施
Experimental
Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks
干预措施: Experimental (Drug)
Placebo comparator
Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks
干预措施: Experimental (Drug)
结局指标
主要结局
The change of T-score of bone mineral density(QCT)
时间窗: baseline, After 24 weeks(± 3 days) from the baseline of the trial
次要结局
- The change of T-score(baseline, After 4 weeks, 12 weeks from the baseline of the trial)
- The change of osteoporosis-related indicators of blood tests(baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial)
- The change of ODI(Oswestry Disability Index)(baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial)
- The change of QVAS(Quardruple Visual Analog Scale)(baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial)
- The change of kupperman index(baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial)
- The change of shin-huh symptoms(baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial)
- The change of quality of life using SF-36(baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial)
研究者
Hyun Lee
Professor
Korea Health Industry Development Institute