A multicenter, randomized, double-blind, controlled trial for Tongluo Sheng Gu Capsule (TLSG) in the treatment of osteonecrosis of the femoral head with TCM syndrome of blood stasis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800019626

Enrollment

Unknown

Registered

2018-11-20

Start date

2014-03-01

Completion date

Unknown

Last updated

2018-11-26

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(ONFH)

Interventions

Group 1:Tongluo Sheng Gu Capsule+Jian Gu Sheng pill simulant

Group 2:Tongluo Sheng Gu Capsule simulant+Jian Gu Sheng pill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years old male and female; (2) meet the diagnostic criteria of avascular necrosis of femoral head and syndrome differentiation of traditional Chinese medicine; (3) according to ARCO staging imaging performance of stage II, III, IV; (4) alcoholic avascular necrosis of femoral head during the trial to prohibit drinking, hormone-induced avascular necrosis of femoral head patients should be discontinued for more than 3 months; (5) voluntary participation in this Clinical trial and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Known or suspected allergy to this drug; (2) hip surgery for patients less than half a year; (3) patients not within the scope of the drug; (4) temporary synovitis, femoral head epiphyseal spondylolisthesis and bone tuberculosis; (5) patients who have taken part in any clinical trial drugs within the first 1 months of screening or selection; (6) Patients who are using other therapeutic drugs or suffering from other diseases and may interfere with the evaluation of drug safety or efficacy; (7) Patients with severe primary diseases such as cardiovascular, cerebrovascular and hematopoietic diseases, psychiatric disorders, and those who are still taking hormones have abnormal liver and kidney function tests (test values higher than the normal upper limit); (8) Prepare for pregnancy, pregnancy and lactation; (9) The researchers considered it inappropriate to choose the subjects.

Design outcomes

Primary

Measure	Time frame
Harris score changes before and after treatment;	—

Secondary

Measure	Time frame
Imaging changes of lesion sites before and after treatment;Changes of TCM syndrome score before and after treatment;	—

Countries

China

Contacts

Public ContactZhan Hongsheng

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

shgsyjs@139.com+86 021-20256519

Outcome results

None listed

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