knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meets the Western medical diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)": (1) Recurrent knee joint pain within the past month; (2) X-ray film (standing or weight-bearing position) shows narrowing of joint space, subchondral bone sclerosis and/or cystic changes, and formation of osteophytes at the joint edge; (3) Age = 50 years old; (4) Morning stiffness time = 30 minutes; (5) There is bone fricative during activity (sensation); Note: Meeting the diagnostic criteria (1)+[any two of (2), (3), (4), and (5)] can diagnose knee osteoarthritis; 2. When included, the patient's Visual Analog Scale (VAS) score ranged from 3.0 to 7.4 points (including 3.0 and 7.4 points); 3. Age range from 40 to 75 years old (including 40 and 75 years old), regardless of gender; 4. The subject's body mass index (BMI) is between 18.5-34kg/m2; 5. Patients in grades I, II, and III who meet the Kellgren&Lawrence grading criteria for X-ray imaging examination (original image materials from tertiary hospitals within 2 months are acceptable); 6. Able to understand and comply with clinical protocol requirements, voluntarily participate in clinical trials, and sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Individuals with allergic constitution, known to be allergic to the ingredients of the drug in this study; 2. Those who meet the Kellgren&Lawrence grading criteria for X-ray imaging examination and are classified as Grade IV; 3. Patients with immune disorders or other diseases that interfere with the efficacy indicators of this study: patients with other inflammatory diseases of the knee joint, such as rheumatoid arthritis, psoriatic arthritis, gout, tumors, villous nodular synovitis, joint trauma, purulent arthritis, and tuberculosis arthritis; Osteoarthritis caused by osteomyelitis, bone tumors, and bone tuberculosis; Patients with purulent, non-specific and other infectious knee osteoarthritis; 4. Individuals with unstable vital signs or severe organic diseases or mental disorders of the cardiovascular, lung, liver, kidney, brain, and hematopoietic systems; 5. Have received acupuncture and moxibustion, oral non steroidal anti-inflammatory drugs, hormone injection or sodium hyaluronate, topical plaster and other treatments in the last week; 6. Pregnant or lactating patients; 7. The researcher believes that any other situation that endangers the safety of the subjects, affects the researcher's evaluation, or results in poor adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue pain score;Safety index; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC Scale Rating;Inflammatory marker C-reactive protein; | — |
Countries
China
Contacts
Peking University First Hospital