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

Phase 4

Not yet recruiting

• Conditions: primary osteoporosis (kidney-yang deficiency syndrome)

• Registration Number: ITMCTR2100005285
• Lead Sponsor: Wangjing Hospital of China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Symptom Grading and Quantitative Score;

Secondary Outcome Measures

Name	Time	Method
P1NP;SF-12 Quality of Life Scale;Bone density;CTX;