Knee osteoarthritis
Conditions
Interventions
Research Group 1:Zhuanggu joint Capsules in combination with Celecoxib
Research Group 2:Zhuanggu joint Capsules in combination with Celecoxib Capsule simulant
Control Group:Zhuanggu joint Capsule stimulant in combination with Celecoxib
Sponsors
Shanghai sixth people's hospital
Eligibility
Sex/Gender
All
Age
38 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 40-70 years old, male or female; (2) Accorded with the diagnostic criteria of knee osteoarthritis[3][4], with X-ray Kellgren-Lawrence classification = grade III; (3) Patients had normal liver and renal function; (4) Patients were willing to receive the drug treatment and signed written informed consent that was in accordance with the GCP requirements. This study gained approval fro the ethics committee of Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, and all the participants signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients suffered from acute joint injury, tuberculosis and tumors of the knee joints and rheumatoid arthritis, etc.; (2) Patients had severe cardiovascular, metabolic, digestive, urinary, neurological, psychiatric disorders or who were excluded by the investigators; (3) Patients took drugs that were prohibited by this treatment protocol, or patients needed to continue the prohibited drugs during the trial; (4) Patients had taken the study drugs within 1 month or had participated in the clinical trials of the drugs; (5) Lactating and pregnant women or women of childbearing age who were planning pregnancy; (6) Patients who were known to have contraindications for Zhuanggu joint Capsules or NSAIDs; (7) Patient who were susceptible or were allergic to the components of the study drugs; (8) Staffs who were directly involved in this trial or relatives of staffs; (9) Patients had alcohol and/or drug abuse or poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster universities osteoarthritis (WOMAC) index; | — |
Countries
China
Contacts
Public ContactZhang Xianlong
Outcome results
None listed