A clinical study of Quanduzhong capsule in treating primary osteoporosis (kidney-yang deficiency syndrome)

Wangjing Hospital of China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•1.Health group
•(1) meet any of the following:
•? Female, 45 years old ? Male, 70 years old = age = 75;
•(2) T value of bone density measurement = -1.0SD;
•(3) Subjects are volunteered to sign the informed consent, and have a correct understanding of the significance of the research.
•2.Experiment group and control group
•(1) Meet the Western medical diagnostic criteria and TCM syndrome criteria;
•(2) Meet the criteria for postmenopausal osteoporosis (type I) or senile osteoporosis (type II);
•(3) meet any of the following:
•? Female, 45 years old ? Male, 70 years old = age = 75;
•(4) Subjects are volunteered to sign the informed consent, and have a correct understanding of the significance of the research.

•(1) Systemic metabolic bone disease;
•(2) Severe osteoporosis with fragility fractures;
•(3) The systolic blood pressure in the clinic is less than 100mmHg or the diastolic blood pressure is less than 70mmHg;
•(4) Chronic diseases that affect bone metabolism, such as diabetes, rheumatoid arthritis, hyperparathyroidism, and hyperthyroidism;
•(5) Severe cardiovascular and cerebrovascular diseases;
•(6) Severe liver, kidney, blood system diseases or malignant tumors, etc. (such as AST, ALT or BUN = 2 times the normal value);
•(7) Severe organic diseases and active osteoarthropathy;
•(8) Used estradiol, calcitonin within half a year, fluoride, bisphosphonate and adrenal cortex hormone within one year;
•(9) Known or suspected to be allergic to the test drug and its ingredients;
•(10) Poor compliance or neurological diseases that cannot cooperate with treatment;
•(11) Participated in other clinical trials 3 months before the trial;
•(12) Pregnant or breast-feeding women or those who have a childbirth plan within the past six months.

发起方

Wangjing Hospital of China Academy of Chinese Medical Sciences