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A multicenter, randomized, double-blind, double-dummy, positive drug parallel controlled clinical trial of Heng-Gu-Gu-Shang-Yu-He-Ji in the treatment of non-traumatic osteonecrosis of the femoral head

A multicenter, randomized, double-blind, double-dummy, positive drug parallel controlled clinical trial of Heng-Gu-Gu-Shang-Yu-He-Ji in the treatment of non-traumatic osteonecrosis of the femoral head

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078938
Enrollment
Unknown
Registered
2023-12-21
Start date
2023-12-21
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Non-traumatic osteonecrosis of the femoral head

Interventions

Test group:Heng-Gu-Gu-Shang-Yu-He-Ji+Tongluo Shenggu Capsule Simulator
control group:Heng-Gu-Gu-Shang-Yu-He-Ji Simulator+Tongluo Shenggu Capsules

Sponsors

The Third Affiliated Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. In accordance with the western medicine diagnosis of osteonecrosis of the femoral head, ARCO stage II-III; 2. Patients undergoing elective core decompression; 3. In accordance with the TCM syndrome differentiation standard of liver and kidney deficiency combined with blood stasis syndrome; 4. Age 18-75 years old, no plans to become pregnant during the screening period and within the next 3 months, take effective contraceptive measures voluntarily, and no plans to donate sperm or eggs; 5. Those who agree to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with transient synovitis, femoral head epiphyseal spondylolisthesis and bone tuberculosis; 2. Patients with osteonecrosis of the femoral head caused by trauma, blood-related diseases, radiotherapy and chemotherapy, long-term use of glucocorticoids, etc. (3) patients with life-threatening diseases of the heart, brain, liver, kidney and blood system, including ALT, AST > 1.5 times the upper limit of normal, Scr > the upper limit of normal; Patients with glaucoma; 4. Patients with allergic constitution or known to be allergic to the drugs and their components used in this trial; Patients enrolled in other clinical trials within 5.3 months; 6. Patients with any factors considered by the investigator to be ineligible for inclusion or to preclude participation or completion of the study.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale (VAS) score;

Secondary

MeasureTime frame
Harris Hip score;Hip flexion function score;TCM syndrome score;

Countries

China

Contacts

Public ContactChen Weiheng

The Third Affiliated Hospital of Beijing University of Chinese Medicine

1732865549@qq.com+86 135 1101 3261

Outcome results

None listed

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