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Clinical efficacy and safety of Gushuling in the treatment of diabetes patients with osteoporosis: a randomized controlled trial

Clinical efficacy and safety of Gushuling in the treatment of diabetes patients with osteoporosis: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087572
Enrollment
Unknown
Registered
2024-07-30
Start date
2024-08-02
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Diabetes with osteoporosis

Interventions

Experimental group:Gushuling+Calcium Carbonate D3 Tablets+Alendronate Sodium Tablets
Control group:Calcium Carbonate D3 Tablets+Alendronate Sodium Tablets

Sponsors

The First Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) At the same time, it meets the diagnostic criteria of diabetes and osteoporosis; 2) Not taking hormone drugs or anti osteoporosis drugs in the past 3 months; 3) Stop all other interventions for this disease; 4) Fasting blood glucose and 2-hour postprandial blood glucose control are stable (fasting blood glucose is controlled between 5-7.5mmol/L, and postprandial blood glucose is controlled within 11.1mmol/L) 5) Patients who do not agree to sign the informed consent form for this study.

Exclusion criteria

Exclusion criteria: 1) Patients with combined diseases such as adrenal, thyroid, kidney, severe cardiovascular disease, or liver and kidney dysfunction; 2) Individuals who are allergic to the use of drugs in this study; 3) Osteoporosis accompanied by one or more bones that require surgical treatment; 4) Those who are not suitable for treatment due to chronic digestive tract diseases and inconvenience in movement; 5) Esophageal abnormalities leading to esophageal emptying disorders and other conditions; 6) Patients with hypocalcemia; 7) Patients with metabolic and rheumatic diseases that affect bone metabolism, or those who take drugs that affect bone metabolism for a long time.

Design outcomes

Primary

MeasureTime frame
Bone density (lumbar spine);

Secondary

MeasureTime frame
Ca P ALP 25(OH) D3 ß-CTx OPG Foxo1 PTGS2;Blood glucose levels: (fasting blood glucose, 2-hour postprandial blood glucose);

Countries

China

Contacts

Public ContactYang Mao

The First Affiliated Hospital of Anhui University of Chinese Medicine

1071794037@qq.com+86 137 3922 2812

Outcome results

None listed

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