Osteoarthritis of the knee
Conditions
Interventions
Group 1:Chinese patent medicine Qu Feng Zhi Tong Capsule
Group 2:Placebo
Sponsors
First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who fulfilled the diagnosis criteria of knee osteoarthritis; 2) The knee joints of patients belongs to grade I-III by X-ray examination (Kellgren/Lawrence score of knee joint); 3) Repeated episodes of knee pain over 15 days in the month before the clinical study, the knee joint pain recurred more than 15d; 4) The score of knee joint pain was higher than 40mm in the past week (according to VAS criteria); 5) If the subjects are taking NSAIDs, the dose has been stabilized for four weeks at least; 6) If the subjects are using of oral glucocorticoids, the dose (equivalent to the dose of prednisone)has been stabilized less than 10mg/d for four weeks at least; 7) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients combined with other rheumatic and metabolic diseases such as Sjogren's syndrome, gout and rheumatoid arthritis, or patients with HIV history; 2) Patients with serious organ lesions, such as heart, liver, kidney, etc. or abnormal liver function (cereal or gluten aminotransferase > 1.5 times the upper limit of normal value), or abnormal renal function (serum creatinine level > upper limit), WBC or PLT were lower than normal lower limit; 3) Patients with infectious knee osteoarthritis or nonspecific infections knee osteoarthritis; 4) Patients with knee joint synovium as the main lesion with traumatic and villous nodular pigmentation; 5) Patients with late joint deformity , disability or serious osteoporosis; 6) Allergic constitution and allergy to experimental drugs; 7) Women in pregnancy, preparation for pregnancy or lactation; 8) Those who are taking antidepressants, antispasmodic drugs, opioids and sedatives. 9) Patients who had been treated with sodium hyaluronate intra-articular within the first 4 weeks of screening;patients used of drugs containing chondroitin sulfate / glucosamine / diacetate in the first 3 months of screening;patients used of biological agents in the first 3 months or participation in any other clinical trial or receipt of an investigational drug within the first 3 months of screening; 10) Patients with organ failure; 11) Some researchers think that the subjects are not suitable for using of Qu Feng Zhi Tong Capsule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee pain index (VAS score); | — |
Secondary
| Measure | Time frame |
|---|---|
| 30s-CST times (30 seconds seat sitting, standing test);40m-FPWT count (40 meter fast walk test);KOOS score for knee joint injury and osteoarthritis;Health Questionnaire (SF-12);MRI examination of knee joint; | — |
Countries
China
Contacts
Public ContactTian Kai
Shaanxi buchang Pharmaceutical Co., Ltd.
Outcome results
None listed