NCT00202956Unknown2 期
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects on Biomarkers and Safety of Bugusan (BGS) in Postmenopausal Patients With Osteoporosis.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 试验地点
- 1
研究概览
简要总结
The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis.
详细描述
The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis by a study of Randomized, Double Blind, Placebo-Controlled, Parallel Group.
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
- Double
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women between the ages of 45 and 75 years with a natural menopause ≧ 6 months and serum E2 values < 20 pg/ml, serum FSH values ≧ 25 mIU/mL;
- •Patients have bone mineral density <-2.5 SD of T score at the lumbar spine (L2-L4);
- •All patients must sign the informed consent form (ICF) prior to the trial.
排除标准
- •Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis;
- •Any X-ray film that documents bone fracture within 3 month prior to the trial.
- •Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial;
- •Use of other Chinese medicine within 2 weeks prior to the trial;
- •Patients with significant renal function impairment (Creatinine>2mg/dl) and liver function impairment (AST and ALT > 2 x the upper limit of normal range);
- •Patients have laboratory test abnormality, which in the investigator's opinion might confound the study;
- •Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV);
- •Patients have life threatening disease;
- •Patients are allergic to any of the composition of Chinese medicine;
- •Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;
研究者
研究点 (1)
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