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Jianshi Kanggu Granules for the treatment of early-stage non-traumatic avascular necrosis of the femoral head: A randomized positive drug-controlled clinical study

Jianshi Kanggu Granules for the treatment of early-stage non-traumatic avascular necrosis of the femoral head: A randomized positive drug-controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002166
Enrollment
Unknown
Registered
2025-11-08
Start date
2025-11-05
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Non-traumatic avascular necrosis of the femoral head (NONFH)

Interventions

Experimental Group:Basic treatment plus Jianpi Kanggu Granules, 1 packet per dose, twice daily, to be taken with warm water after meals for a duration of 3 months.
Control Group:Basic treatment + Xianling Gubao capsules, 4 capsules per dose, twice daily, orally for 3 months.

Sponsors

Beijing University of Chinese Medicine Third Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Simultaneously meet the diagnostic criteria for NONFH and the syndrome differentiation criteria; (2) Patients with at least one side of avascular necrosis of the femoral head at ARCO Stage II; (3) Age between 18-55 years, with a disease duration of no more than 1 year; (4) No clear history of hip joint trauma; (5) Cessation of steroid medications for at least 3 months; (6) Patients who have signed the informed consent form to participate in the study.

Exclusion criteria

Exclusion criteria: (1) The primary disease is severe and requires other treatments that may affect the results of this trial; (2) Participants who have received other new drug clinical trials within the past six months; (3) Patients currently using medications that affect lipid metabolism, anti-coagulation, or blood-activating therapies; (4) Pregnant or intending to become pregnant individuals, as well as lactating women; (5) Participants with a history of allergy to multiple medications or those with an allergic constitution; (6) Patients with mental disorders or substance abuse/dependence on psychoactive substances; (7) Patients with hepatic or renal insufficiency, or coagulation disorders.

Design outcomes

Primary

MeasureTime frame
Imaging therapeutic effect score;

Secondary

MeasureTime frame
Hip Joint Pain Intensity;Hip Flexion Function;Walking Distance;Surgery rate;

Countries

China

Contacts

Public ContactLee Tae Hyun

Beijing University of Chinese Medicine Third Affiliated Hospital

drlitaixian@163.com18600697752

Outcome results

None listed

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