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Efficacy and Safety of Bu-Sui-Dan Combined with Alendronate Sodium Tablets in the Treatment of Senile Osteoporosis of Kidney-Yang Deficiency Type: A Single-Center Randomized Controlled Trial

Clinical observation on the treatment of kidney yang deficiency type osteoporosis with marrow tonic elixir

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000369
Enrollment
Unknown
Registered
2024-09-04
Start date
2023-03-17
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Osteoporosis

Interventions

Observation Group:The treatment includes Calcium Carbonate D3 Tablets and Alendronate Sodium Tablets, supplemented with BSD
Control Group:Calcium Carbonate D3 Tablets and Alendronate Sodium Tablets

Sponsors

Wuxi Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meets the above diagnostic criteria for osteoporosis and TCM kidney-yang deficiency syndrome. 2. Aged between 45 and 75 years, with no gender restrictions. 3. Low back pain lasting at least 3 months, with a VAS score of 3 = VAS < 7. 4. Patients with full civil capacity, understanding of the study process and methods, and who signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary osteoporosis. 2. Severe osteoporosis leading to limb deformities or disabilities. 3. Patients with serious complications of the cardiovascular, hepatic, renal, or digestive systems, hematological disorders, psychiatric diseases, or a history of malignancy. 4. Patients who have used anti-osteoporosis drugs within the past six months. 5. Patients with implants in the lumbar spine or hip that affect bone density. 6. Patients allergic to any herbal components of Alendronate Sodium Tablets or BSD. 7. Patients with a history of smoking or alcohol abuse (more than 15 grams of alcohol per day, equivalent to 350 mL of beer or 150 mL of wine, more than twice a week) or substance abuse in the past six months. 8. Patients who have participated in other clinical trials within the past three months.

Design outcomes

Primary

MeasureTime frame
visual analog scale;—

Secondary

MeasureTime frame
Chinese Osteoporosis Quality of Life Questionnaire (COQOL) Score;Short Form of Quality of Life (SF-36) Scale;Bone Mineral Density;Bone Metabolism Indicators;Traditional Chinese Medicine (TCM) Symptom Score;—

Countries

China

Contacts

Public ContactXiaofeng Liu

Wuxi Hospital of Traditional Chinese Medicine

wxzy008@njucm.edu.cn13616173567

Outcome results

None listed

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