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A randomized controlled clinical trial of Bushen Huoxue recipe in the prevention and treatment of osteoporotic fractures

A randomized controlled clinical trial of Bushen Huoxue recipe in the prevention and treatment of osteoporotic fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000928
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-03-14
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Osteoporotic fractures

Interventions

test group:Bushen Huoxue Prescription
Control group:Conventional anti-osteoporosis treatment

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) According to the above diagnostic criteria of western medicine OVCF is a single vertebral fresh compression fracture; (2) "kidney deficiency and blood stasis type" according to TCM syndrome differentiation; (3) The T value of lumbar spine bone mineral density =-2.5; (4) OVCF patients aged =50 years old; (5) Exclusion of surgical contraindications; (6) can clearly describe their own condition and be willing to cooperate with treatment and follow-up; (7) MRI showed fresh vertebral compression fracture without symptoms of spinal cord and nerve compression. (8) had not received any other related treatment 2 weeks before this treatment; (9) The subjects were fully informed and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) those who do not meet the diagnostic criteria of western medicine and TCM syndrome; (2) patients with secondary osteoporosis or juvenile osteoporosis; (3) those who could not cooperate with the trial (those who could not follow the basic treatment requirements of the trial or take drugs according to the doctor's advice) and psychiatric patients; (4) combined with serious primary diseases of cardiovascular and cerebrovascular liver kidney and hematopoietic system or serious organ diseases or malignant tumor diseases or renal calculi by B-ultrasound; (5) patients with endocrine diseases such as thyroid adrenal gland diseases and other diseases that seriously interfere with bone metabolism; (6) patients with allergic constitution history of drug allergy or known allergic to experimental drug components; (7) those who are in critical condition and unable to evaluate the efficacy and adverse reactions of drugs; (8) patients who were enrolled or had recently enrolled (within 1 month) in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Therapeutic Index;

Secondary

MeasureTime frame
vital signs;The Oswestry Disability Index;Complete Blood Count;Bone mineral density;Four coagulation tests;visual analogue scale;clinical symptoms;Stool Examination;Urinalysis;electrocardiogram examination;X ray;

Countries

China

Contacts

Public ContactXiaofeng Zhu

Teacher-student relationship

zxiaof@jnu.edu.cn13632228906

Outcome results

None listed

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