Acute soft tissue injury (acute lumbar sprain) (qi stagnation and blood stasis syndrome)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for acute lumbar sprain; (2) TCM syndrome differentiation is qi stagnation and blood stasis syndrome; (3) Aged 18 to 65 years old (including the boundary value); (4) The time from the onset to the first visit does not exceed 48 hours; (5) Pain symptom VAS score >=40mm; (6) Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients requiring orthopedic or surgical treatment; (2) Patients have suffered damage within 3 months of the same target target site; (3) Patients had 3 or more injuries in the same part within 12 months before the injury; (4) Patients who have undergone previous lumbar surgery; (5) Patients with lumbar disc herniation, spinal stenosis, vertebral detachment, ankylosing spondylitis, ankle joint disease; (6) The drug site includes: patients with skin wounds, patients with poor skin condition, and patients with skin allergies; (7) Using anti-inflammatory and analgesic drugs such as non-steroidal anti-inflammatory drugs or traditional Chinese medicines for promoting blood circulation, relieving swelling and relieving pain, within 12 hours before enrollment; (8) After the onset of the disease, the sprained part has received acupuncture, physiotherapy, massage and other treatments; (9) Combined fracture, infection, tumor, joint dislocation, severe open injury of soft tissue, and nerve, blood vessel, important muscle, organ injury; (10) Severe cardiovascular disease, liver disease (ALT, AST = 2 times the upper limit of normal value), kidney disease (Scr> upper limit of normal value), blood disease (coagulation abnormalities have clinical significance, hematopoietic dysfunction, spleen function) Patients with hyperthyroidism, bleeding tendency, etc.), infectious diseases, tumors and other serious comorbidities; (11) Patients can not cooperate with the completion of clinical trials; (12) Patients are unable to take medication on time according to the plan and return to the hospital on time, etc., think that the compliance is poor; (13) Pregnant or pregnant women, as well as lactating women; (14) Patients are participating in or participating in other drug clinical trials within one month; (15) Patients are allergic to the test compound, emergency medication (celecoxib capsule) and sulfa drugs; (16) Other circumstances that the investigator believes are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the pain curve;Tenderness VAS score;Clinical efficacy (clinical cure rate, significant efficiency, efficiency);TCM syndrome score;Single symptom score;Oswestry dysfunction index score; | — |
Countries
China
Contacts
Wangjing Hospital, China Academy of Chinese Medical Sciences