Knee Osteoarthritis
Conditions
Interventions
Treatment group:conventional treatment+oral granules of Erzhiwan Jiawei
Control group:conventional treatment+oral placebo
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? Those who meet the diagnostic criteria for Western medicine and traditional Chinese medicine syndromes mentioned above; ? Age range from 18 to 75 years old; ? Patients who have not undergone knee joint surgery in the past, have not received KOA related treatment in the past month, or have a washout period of at least 14 days after receiving treatment; ? For those with K-L imaging grades of I-III, X-ray grading shall refer to the K-L imaging grading method; ? Voluntarily participate and sign an informed consent form to cooperate with follow-up; ? The onset of knee osteoarthritis in the patient is unilateral knee joint.
Exclusion criteria
Exclusion criteria: ? Knee joint swelling and fever; ? Metabolic bone disease and chronic severe disease caused by endocrine disorders; ? Pregnant, pre pregnancy or lactating women, as well as mentally ill patients; ? Individuals who have received glucocorticoid treatment or knee arthroscopy within the past 2 months; ? Individuals who have suffered knee injuries or undergone surgical procedures within the past 6 months; ? Individuals who are allergic to any component of the investigational drug; ? Congenital knee joint developmental abnormalities or vascular and nerve injuries; ? Patients with significantly narrowed knee joint space that meets surgical indications; ? Those who are unable to use medication and receive treatment according to regulations, have poor compliance, cannot determine the efficacy or incomplete treatment, which affects the efficacy and safety judgment; ? Individuals who have participated or are currently participating in other clinical trials within the past month. Note: Patients who meet any of the above criteria will be excluded from the study scope.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Osteoarthritis Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lysholm;VAS;Knee joint range of motion;TCM syndrome score;Criteria for the therapeutic effect of TCM syndromes;Knee joint ultrasound;Knee joint MRI;hepatic and renal function;Blood routine;Incidence of adverse events;Serum inflammatory factors; | — |
Countries
China
Contacts
Public ContactLiu Aifeng
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed