Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Bone Mineral Density
研究概览
简要总结
Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected with decrease of renal function. In traditional Chinese medicine, kidney function is considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment will help improve bone development and metabolism.
详细描述
In this study patients with chronic renal insufficiency and secondary osteoporosis or bone loss will be evaluated with traditional Chinese medicine standard and allocated into kidney Yin deficiency and kidney Yang deficiency groups. In Yin deficiency group, patients will be divided into Zuogui granules treatment group and placebo group. In Yang deficiency group, patients will be divided into Yuogui granules treatment group and placebo group. All the patients will also accept basic treatment.
After 3-month-treatment, we will detect blood urea nitrogen, creatinine, bone mineral density, bone metabolism markers including FGF23, 1,25(OH)2D3, Osteocalcin, PTH, BALP, serum and urinal Ca, P. We will also perform miRNA array. The data before treatment and after treatment will be compared. The data of treatment groups and placebo groups will also be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •chronic renal insufficiency
- •bone loss or osteoporosis
- •30-50 years old
- •kidney Yin or Yang deficiency evaluated with traditional Chinese medicine
- •be willing to and be able to join in the study and signed Informed consent
- •have not accepted systematical treatment on bone loss or osteoporosis
排除标准
- •allergies
- •secondary osteoporosis caused by other diseases.
- •postmenopausal women
- •mental illness or psychosis
- •patients with bone fracture and need surgery treatment
- •taking any medicine that will affect bone metabolism for a long time and can not stop
- •women during pregnant stage and breast-feed stage
研究组 & 干预措施
kidney Yin deficiency with placebo
chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment.
干预措施: Zuogui granules placebo (Drug)
kidney Yang deficiency with placebo
chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment.
干预措施: Yougui granules placebo (Drug)
kidney Yin deficiency with Zuogui
chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment.
干预措施: Zuogui granules (Drug)
kidney Yang deficiency with Yougui
chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment.
干预措施: Yougui granules (Drug)
结局指标
主要结局
Bone Mineral Density
时间窗: 3 months
次要结局
- Kidney Yin and Yang evaluation(3 months)
- Blood Urea Nitrogen(3 months)
- creatinine(3 months)
- bone metabolism(3 months)
研究者
Bing Shu
assistant research fellow
Shanghai University of Traditional Chinese Medicine