Efficacy and safety observation of Xianling Gubao capsule after hip-preserving surgery in patients with early stage osteonecrosis of the femoral head: a multicenter, randomized, parallel control study
- Conditions
- osteonecrosis of the femoral head
- Registration Number
- ITMCTR2100004392
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Age from 18 to 65, gender is not limited.
2. Patients have a history of high-dose corticosteroid use who was diagnosed as avascular necrosis of the femoral head (ARCO stage I, II or IIIA) by MRI examination, and scientific and standardized hip preserving surgery was selected according to CJFH.
3. Can understand the study and sign the informed consent.
1.Patients with severe primary disease is not suitable for participating in this study.
2 The first MRI scan (T1, T2-weighted phase, coronal) of both hips after inclusion confirmed no osteonecrosis of the femoral head.
3.Pregnant or lactating women;
4 Allergic constitution and allergic to a variety of drugs.
5.Patients with serious cardiovascular and cerebrovascular diseases;
Liver and renal insufficiency;
Hematopoietic system disease;
Severe digestive tract disease;
Patients with serious underlying diseases of the mental and central nervous system.
6. People with bleeding tendency or Hyperlipidemia.
7. Patients who are not suitable for magnetic resonance examination (leisure disease, with heart pacemaker, metal contraceptive ring, etc.).
8. Other conditions considered by the investigator not suitable for participation in the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CT scans;Harris score;X-rays;rate of adverse reaction;VAS score;
- Secondary Outcome Measures
Name Time Method hepatorenal function;blood routine examination;