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safety and efficacy of treatment of chronic bone and joint infection with Puling granules, a RCT research

Integrated traditional Chinese and western medicine clinical research of treatment of chronic bone and joint infection with "Puling drug granules"

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083733
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

infection of bone and joint

Interventions

experimental group:treating with Integrated traditional Chinese and western medicine
control group:conventionnal treatment

Sponsors

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: western medicine diagnostic criteria of chronic bone and joint infection. 1) course of disease no less than 3 weeks; 2) swelling and tenderness; 3) rise of WBC or CRP; 4) sign of infection in X-ray or PET-CT. accord with above 1) , 4) and either of 2) or 3), exclude tuberculosis and tumor. Chinese medicine diagnostic criteria of syndrome of damp-heat and blood-stasis obstruction. 1) course of disease no less than 3 weeks; 2) pain, can not move; 3) swelling, burning hot, tenderness and percussion pain; 4) tongue red and tongue coating yellow, pulse quick. enrollment cretiria: 1,Meet the western medicine diagnostic criteria of chronic bone and joint infection 2,Meet the chinesn medicine diagnostic criteria of syndrome of damp-heat and blood-stasis obstruction. 3.Age from 18-70,male of female

Exclusion criteria

Exclusion criteria: 1, with diabete or sepsis. 2, with serious disease of kidney or liver. 3.incooperative and refuse to sign the informed consent

Design outcomes

Primary

MeasureTime frame
rate of treatment efficacy;

Secondary

MeasureTime frame
efficacy of symptoms in TCM;laboratory test:WBC and CRP;recurrence of infection: pain and dwelling;

Countries

China

Contacts

Public ContactQi Li

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

drlee12@sjtu.edu.cn+86 189 3017 4685

Outcome results

None listed

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