Femoral shaft fracture (Qi stagnation and blood stasis syndrome)
Conditions
Interventions
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. patients with unilateral femoral shaft fracture received anterograde intramedullary needle internal fixation and successful closed reduction; 2. consistent with TCM syndrome differentiation and diagnosis of qi stagnation and blood stasis; 3. patients within 24 hours after surgery; 4. men aged 18 to 60 years old, women aged 18 to 50 years old; 5. after the researchers detailed the advantages and disadvantages of the study, the patients were willing to participate in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. pathological fracture; 2. patients with soft tissue infection at the operation site; 3. patients with pain caused by other diseases; 4. combined with severe diseases of heart, lung, liver, kidney and hematopoietic system, ALT, AST > 2 times normal reference value upper limit, upper limit of Scr > normal reference value; 5. pregnancy, lactation or intended pregnancy, including male subjects who have fertility intention or family planning during the study period; 6. history of mental illness and glaucoma; 7. other drugs affecting the evaluation of disease efficacy, such as bisphosphonate, calcitonin, and stimulant, were used within 30 days prior to enrollment Vegetarian drugs, etc. 8. those who are known to be allergic to or allergic to the ingredients of this drug; 9. according to the judgment of the researcher, follow-up and compliance of the subjects may be affected after enrollment, such as out-of-town patients, unstable life, inconvenient traffic, etc. 10. patients enrolled in other clinical trials within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score for pain;Radiographic Union Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fracture Healing Time;Swelling time;Pain time;Frequency and dosage of analgesics;TCM score;Single symptom of TCM;European five-dimensional health scale (eq-5d) score;Security Index;Pharmacoeconomic evaluation index; | — |
Countries
China
Contacts
Public ContactWu Xinbao
Beijing Jishuitan Hospital
Outcome results
None listed