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Comparative study on the clinical efficacy and safety of Bushen Jianpi Huoxue prescription granules and traditional decoction in the treatment of osteoporosis

Comparative study on the clinical efficacy and safety of Bushen Jianpi Huoxue prescription granules and traditional decoction in the treatment of osteoporosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088234
Enrollment
Unknown
Registered
2024-08-14
Start date
2024-08-19
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Osteoporosis

Interventions

Bushen Jianpi Huoxue granules:Bushen Jianpi Huoxue granules
Bushen Jianpi Huoxue traditional decoction:Bushen Jianpi Huoxue traditional decoction
Alendronate:Alendronate

Sponsors

The Third Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Women who have been through menopause for =1 year and men who are =60 years old; can cooperate in basic data collection, bone density examination, body composition analysis and serological testing; voluntarily participate in this study and sign an informed consent form. 2. Meet the diagnostic criteria for osteoporosis; 3. Meet the diagnostic criteria for spleen and kidney yang deficiency in traditional Chinese medicine.

Exclusion criteria

Exclusion criteria: Those who are combined with serious cardiovascular and cerebrovascular, liver, kidney and other important organ diseases; those who are combined with major diseases of the respiratory, digestive tract, urinary and other systems; those who are combined with diseases that affect bone density and calcium and phosphorus metabolism; those who are combined with malignant tumors; those who have recently taken Patients with drugs that affect bone metabolism and body composition; those who are too obese to undergo bone density examination and body composition analysis; women who have undergone oophorectomy or hysterectomy before menopause; those who suffer from neurological diseases that cause insight Those who are deficient; those who are illiterate and unable to answer lifestyle questionnaires and quality of life assessments; those who have participated in other academic researchers, etc.

Design outcomes

Primary

MeasureTime frame
Mean bone mineral density of the lumbar spine (L2-L4);Type I procollagen N-terminal propeptide;Osteocalcin;ß colloidal degradation product;QUALEFFO-41;

Secondary

MeasureTime frame
25(OH)D;osteoclastogenesis inhibitory factor;receptor activator for nuclear factor-?B;

Countries

China

Contacts

Public ContactHuang Hongxing

The Third Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

gzhhx@126.com+86 139 2272 6488

Outcome results

None listed

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