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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100005285

Enrollment

Unknown

Registered

2021-09-08

Start date

2021-10-15

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary osteoporosis (kidney-yang deficiency syndrome)

Interventions

1:NA

2:Quanduzhong capsule

3:Quanduzhong capsule simulant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Health group (1) meet any of the following: ? Female, 45 years old <age = 75; ? 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 <age = 75; ? 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

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.

Design outcomes

Primary

Measure	Time frame
Clinical Symptom Grading and Quantitative Score;	—

Secondary

Measure	Time frame
P1NP;SF-12 Quality of Life Scale;Bone density;CTX;	—

Countries

China

Contacts

Public ContactYANG Kexin

Wangjing Hospital, China Academy of Chinese Medical Sciences

13611261137@163.com010-84739194

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026