Clinical Study on Quanduzhong Capsule in Treating Primary Osteoporosis (Kidney-Yang Deficiency Type)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050932

Enrollment

Unknown

Registered

2021-09-08

Start date

2021-10-15

Completion date

Unknown

Last updated

2022-05-16

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 Type)

Interventions

Group 1:None

Group 2:Quanduzhong capsule

Group 3:Quanduzhong capsule simulant

Eligibility

Sex/Gender

All

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Healthy group: (1) Conform to any of the following: 1) Female, Aged > 45 and = -1.0SD; (3) The subjects voluntarily signed the informed consent form, and had a correct understanding of the significance of the research. 2. Experimental group and control group: (1) Comply with the above-mentioned Western medicine diagnostic criteria and TCM syndrome criteria; (2) Meet the criteria for postmenopausal osteoporosis (type I) or senile osteoporosis (type II); (3) Conform to any of the following: 1) Female, Aged > 45 and <= 75 years; 2) Male, aged 70-75 years; (4) Subjects voluntarily signed the informed consent form, and had a correct understanding of the significance of the research.

Exclusion criteria

Exclusion criteria: 1. Systemic metabolic bone disease; 2. Severe osteoporosis with fragility fracture; 3. Office blood pressure systolic blood pressure = 2 times the normal value); 7. Severe organic disease and active osteoarthropathy; 8. Have used estradiol, calcitonin within half a year, fluoride, bisphosphonates and adrenocortical hormones within one year; 9. Known or suspected allergy to the test drug and its components; 10. Poor compliance or neurological disease unable to cooperate with treatment; 11. Participated in other clinical trials 3 months before the trial; 12. Pregnant, breastfeeding patients or those who have a childbearing plan within the past six months.

Design outcomes

Primary

Measure	Time frame
Clinical symptom grading quantitative score;	—

Secondary

Measure	Time frame
Bone density;Type I procollagen N-terminal propeptide;Type I collagen C-terminal cross-linking peptides;SF-12 Quality of life scale;	—

Countries

China

Contacts

Public ContactYang Kexin

Wangjing Hospital of China Academy of Chinese Medical Sciences

13611261137@163.com+86 10 84739194

Outcome results

None listed

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