Chronic bone and joint infection
Conditions
Interventions
Control:Conventional Western treatment plus placebo
Interventional group:Conventional Western treatment plus Puling granules
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ( 1 ) Western medicine diagnostic criteria for chronic bone and joint infection : acute limb infection or history of open trauma ; the course of disease was more than 3 weeks ; local redness and swelling sinus ulceration can be accompanied by pus or exudate after prolonged unhealed ; white blood cells CRP may be elevated or normal ; x-ray showed dead bone dense bone formation or dead space cladding. ( 2 ) Chronic bone and joint infection ( Fugu gangrene ) damp heat stasis syndrome TCM diagnostic criteria : course of not less than 3 weeks ; limb ( place ) pain inability to move ; local swelling burning obvious tenderness and percussion pain pus viscosity ; red tongue yellow fur pulse number. Patients with a single bone or joint non-specific infection of the lower extremity should meet the following inclusion criteria : 1) In line with the above western medicine diagnostic criteria; 2) In line with the clinical syndrome differentiation of damp-heat intrinsic in traditional Chinese medicine; 3) Patients aged between 18-70 years old men and women are not limited. 4) Subjects informed consent voluntary subjects informed consent process in line with the provisions of the GCP.
Exclusion criteria
Exclusion criteria: 1) Patients in critical condition ( such as complicated with specific infection sepsis and sepsis etc. ) or with surgical indications ; 2) Special population : extremely obese people pregnant women or lactating women mental illness long-term smoking population ; 3) Special diseases : malignant tumor immunodeficiency allergic reaction and limb vascular disease ; 4) Patients with severe primary diseases such as heart cerebrovascular and blood system liver function alanine aminotransferase ( ALT ) greater than 2 times the upper limit of normal value renal function creatinine ( Cr ) greater than the upper limit of normal value ; 5) Patients who had used the relevant Chinese and Western medicine for the treatment of this disease within 1 month before the group which made it difficult to judge the efficacy of the drug ; 6) Allergic constitution or known to be allergic to the drugs and their components used in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SF-36 quality of life score was used to evaluate the therapeutic effect.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local infection recurrence and swelling and pain of the affected area;Laboratory parameters;The curative effect of TCM symptoms to determine the therapeutic effect; | — |
Countries
China
Contacts
Public ContactYang Qingcheng
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Outcome results
None listed