Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bone density（BMD）
研究概览
简要总结
Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. This project adopts the experience of the person in charge of the project-Xulin Jiangu Granules and clinically collects patients with postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome).
详细描述
Randomized control method was used to observe the clinical efficacy of the treatment of postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome) with jiujian jiangu granules, combined with the gene expression of bone metabolism markers BALP, PINP, TRACP and S-CTX, and RANK, RANKL and OPG Detection, compared with the control group of ossification trihydrate capsules, to explore the mechanism of the treatment of postmenopausal osteoporosis by the continued Xulin Jiangu granules, and lay the foundation for the development of new drugs.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •at least 2 years prior and met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis
- •met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine
排除标准
- •patients who did not meet the diagnostic criteria for osteoporosis or CM standards
- •patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
- •patients with abnormal liver and/or Shen function test results
- •patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.
研究组 & 干预措施
Xulin Jiangu granules
Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months
干预措施: Xulin Jiangu granules (Drug)
Xulin Jiangu granules
Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months
干预措施: Calcitriol capsules (Drug)
Calcitriol capsules
Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months
干预措施: Xulin Jiangu granules (Drug)
Calcitriol capsules
Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months
干预措施: Calcitriol capsules (Drug)
结局指标
主要结局
Bone density（BMD）
时间窗: Xulin Jiangu treats for up to six months
BMD is the gold standard of oeteoporosis
次要结局
未报告次要终点