Fracture of the long tubular bone of the lower extremity
Conditions
Interventions
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Patients with a single lower limb long tubular bone fracture [femoral shaft fracture tibial fibular fracture (tibial shaft fracture)] and successfully underwent antegrade intramedullary needle internal fixation with closed reduction; 2) Consistent with the syndrome differentiation diagnosis of qi stagnation and blood stasis syndrome in traditional Chinese medicine; 3) Patients within 24 hours after surgery; 4) Male 18~60 years old (including 18 years old and 60 years old) female 18~50 years old (including 18 years old and 50 years old); 5) After the investigator explains the pros and cons of the trial in detail the patient is willing to participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) pathological fractures; 2) Patients with soft tissue infection at the surgical site; 3) Patients with pain caused by other diseases; 4) Patients with severe heart lung liver kidney and hematopoietic system diseases ALT and AST > twice the normal reference value Upper limit SCR > upper limit of normal reference value; 5) Patients with acute cerebrovascular disease diabetes mellitus with unsatisfactory blood sugar control grade III hypertension or unstable blood pressure control above high risk; 6) Pregnant lactating or intending to become pregnant including male subjects who have fertility intentions or fertility plans during the study period; 7) Patients with a history of psychiatric illness and glaucoma. 8) Use of other drugs that affect the evaluation of disease efficacy within 30 days before enrollment such as bisphosphonates calcitonin and stimulus Vegetarian drugs etc.; 9) Those who are known to be allergic to the ingredients of this drug or have allergic constitution; 10) According to the judgment of the investigator conditions that may affect the follow-up and compliance of the subjects after enrollment such as out-of-town disease unstable life inconvenient transportation and other situations that are easy to cause loss of follow-up; 11) Patients who have participated in other clinical trials within 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score for pain;Radiographic Union Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and dosage of analgesics;European five-dimensional health scale (eq-5d) score;Fracture Healing Time;Swelling time;Pain time;TCM score;Single symptom of TCM; | — |
Countries
China
Contacts
Public ContactWu Xinbao
Beijing Jishuitan Hospital
Outcome results
None listed