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Traditional Chinese and Western Medicine collaborative treatment of refractory chronic bone and joint infection

Traditional Chinese and Western Medicine collaborative treatment of refractory chronic bone and joint infection

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084058
Enrollment
Unknown
Registered
2024-05-09
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic bone and joint infection

Interventions

Control:Western medicine routine debridement treatment
Interventional group:On the basis of routine debridement treatment of western medicine, the intervention treatment of traditional Chinese medicine ( TCM ) based on osteomyelitis decoction ( Puling gra

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead Sponsor

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 : ? In line with the above western medicine diagnostic criteria; ? In line with the clinical syndrome differentiation of damp-heat intrinsic in traditional Chinese medicine; ? Patients aged between 18-70 years old, men and women are not limited. ? Subjects informed consent, voluntary subjects, informed consent process in line with the provisions of the GCP.

Exclusion criteria

Exclusion criteria: ? Patients in critical condition ( such as complicated with specific infection, sepsis and sepsis, etc. ) or with surgical indications ; ? Special population : extremely obese people, pregnant women or lactating women, mental illness, long-term smoking population ; ? Special diseases : malignant tumor, immunodeficiency, allergic reaction and limb vascular disease ; ? 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 ; ? 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 ; ? Allergic constitution or known to be allergic to the drugs and their components used in this experiment.

Design outcomes

Primary

MeasureTime frame
SF-36 quality of life score was used to evaluate the therapeutic effect.;

Secondary

MeasureTime frame
The curative effect of TCM symptoms to determine the therapeutic effect;Laboratory parameters;Local infection recurrence and swelling and pain of the affected area;

Countries

China

Contacts

Public ContactYang Qingcheng

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

tjyqc@163.com+86 189 3017 7328

Outcome results

None listed

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