Randomized Controlled Trial of Classic Yin and Yang Tonic Formula in Osteopenia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- bone mineral density
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the classic yin and yang tonic formula for osteopenia and to research the mechanism of efficacy.
详细描述
Osteoporosis is a growing problem worldwide, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD) only moderately lower than young normal individuals) Since life long drug therapy is an expensive option with uncertain consequences and side effect, natural herbal therapy offers an attractive alternative. The classic Yin and Yang Tonic Formula (eg.Zuogui Pill, Yougui Pill) have been used for osteoporosis or osteopenia in traditional Chinese medicine(TCM) for a long time. For this reason, Chinese guidelines for the treatment of osteopenia include natural herbal therapy, however, there is currently no randomize placebo controlled trial to verify the efficacy for treating low BMD. This trial is randomized, double blind, placebo controlled design. Results of this study will provide evidence regarding the value of the classic Yin and Yang tonic formula as an intervention for increase BMD and decreasing fracture risk in osteopenia. Furthermore, the mechanisms of action can be identified by this study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMD T-scores of the hip (femoral neck or trochanter)and/or spine between -1.0 and -2.5;
- •pattern differentiation is kidney deficiency in TCM.
- •informed consent.
排除标准
- •Osteoporotic (T-score< -2.5) at any site or a fracture in the past 2 years not caused by motor vehicle accident;
- •prior or current use of medication that increase risks of fracture (e.g. steroids, anti-convulsants, anticoagulants,lithium);
- •prior or current use of medications that modify bone metabolism (e.g. bisphosphonates, selective estrogen receptor modulators such as Raloxifene);
- •use of calcium supplements above levels suggested within the recommendations of standard care (i.e., above 1200-1500 mg);
- •current or prior year use of estrogen or calcitonin;
- •Malignancies other than skin cancer;
- •conditions that cause secondary osteoporosis (e.g. Cushing's syndrome, Marfan's syndrome);
- •lactation and gestational period;
- •physical or mental disabilities that will preclude informed consent or active study participation;
- •supersensitivity body constitution.
- •osteoporotic fracture of having operating indication.
研究组 & 干预措施
chinese herb
干预措施: Yin and Yang tonic granules (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
bone mineral density
时间窗: 6 months
次要结局
- pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI.(6 months)