ITMCTR2026001707进行中（未招募）Unknown
Clinical Study on the Efficacy and Safety of Gukang Capsules in the Treatment of Osteoporotic Fracture (Liver and Kidney Deficiency Type)
Wangjing Hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 2026年7月10日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 50 至 100（—）
- 性别
- All
入选标准
- •Age =50 years, with no gender restriction [1];
- •Meet the Western medical diagnostic criteria for osteoporotic fractures as outlined in the "China Guidelines for Diagnosis and Treatment of Osteoporotic Fractures" [10]; The fracture site should be a fresh spinal compression fracture that is amenable to non-surgical treatment, with a Genant classification of mild severity [3]; Meet the TCM syndrome differentiation criteria for liver-kidney deficiency pattern [11]; Participants must understand and comply with the study protocol, provide full informed consent voluntarily, and sign an informed consent form.
排除标准
- •Patients who have used anti-osteoporosis medications such as bisphosphonates or teriparatide/desmopressin within the preceding 6 months; those on long-term glucocorticoid therapy (prednisone =5 mg/day for>3 months); individuals currently using anticoagulants (warfarin, rivaroxaban, etc.) [12]; patients with spinal deformities or those who have undergone lumbar or hip surgery and are unable to undergo DXA testing; those with uncontrolled hyperthyroidism (TSH <0.1 mIU/L); those with hyperparathyroidism (PTH>2 times the upper limit of normal); those with uncontrolled diabetes (HbA1c>9%) [13]; patients with severe cardiovascular or cerebrovascular diseases, chronic liver disease (ALT or AST =1.5 times the upper limit of normal reference values), or renal disease (serum creatinine>the upper limit of normal reference values) [13]; patients with known immunodeficiencies such as untreated or active malignancies, organ or bone marrow transplantation, or those taking immunosuppressants within the past 3 months [13]; pregnant women, women with suspected pregnancy, those planning pregnancy (within 3 months after study completion), or breastfeeding women [13]; individuals with allergic predisposition or known hypersensitivity to study medications [13]; patients who participated in other clinical trials within the preceding 3 months; those with mental disorders or cognitive impairments that would prevent cooperation with the study; or patients deemed by investigators to be intolerant to study medications or with any other contraindications to participation in the study.
研究者
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