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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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004392
Enrollment
Unknown
Registered
2021-02-05
Start date
2021-02-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

osteonecrosis of the femoral head

Interventions

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
CT scans;Harris score;X-rays;rate of adverse reaction;VAS score;

Secondary

MeasureTime frame
hepatorenal function;blood routine examination;

Countries

China

Contacts

Public ContactWei Sun

China-Japan Friendship Hospital

sun887@163.com+86 13910259975

Outcome results

None listed

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