Optimization of External Treatment for Knee Osteoarthritis: a Randomized and Controlled Clinical Trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) According to the above diagnosis standards of Western medicine and the consensus of experts on traditional Chinese medicine diagnosis and treatment of knee osteoarthritis (2015 Edition), patients with knee osteoarthritis of qi stagnation and blood stasis, cold dampness obstruction type;
2) Aged >= 40 years, male or female;
3) The X-ray evidence of knee osteoarthritis was grade 0-III (Kellgren Lawrence rating);
4) BMI <= 35kg / m2; BMI = weight (kg) / height (m) ^2;
5) At least one of the five questions on the pain subscale in the WOMAC score scored 40 or higher.
6) Patients who have not been treated with knee osteoarthritis system within 2 weeks can complete the treatment according to the plan and can cooperate with clinical observers and follow-up.
7) After the subjects fully understand the nature of the study, the nature of their disease, the characteristics of the test drug, the relevant treatment methods and the possible risks to be borne by participating in the study, they can understand and sign the informed consent.

Exclusion Criteria

1) Other inflammatory and painful diseases of the knee joint: rheumatism / rheumatoid arthritis, psoriasis arthritis, gout, hemophilic arthritis, infectious arthritis, etc.
2) Pain injury of knee joint other than osteoarthritis of the knee, such as an intraarticular tumor, villonodular synovitis, acute joint trauma (meniscus tear, ligament injury, bone cartilage contusion, and fracture), etc.
3) Pregnant and lactating women.
4) There are severe cardio cerebral vessels (cerebral infarction and sequelae in recent 6 months, myocardial infarction in recent 6 months), liver (alt, AST are the upper limit of normal value 2 Patients with multiple or above), kidney disease (patients with blood creatinine exceeding the upper limit of normal value), diabetes mellitus requiring insulin injection or poor blood glucose control (fasting blood glucose >= 10mmol / L), coagulation dysfunction (thrombocytopenia, hemophilia, etc.).
5) Patients with skin defects or ulcers around the affected knee joint.
6) The deformity of genu varus > 10 degrees, genu valgus > 20 degrees and joint space disappeared.
7) Patients who have taken glucocorticoids or participated in clinical trials of other drugs within one month before this trial.
8) The patients who were treated in the first 3 months of this trial included intra-articular medication, intra-articular irrigation, and arthroscopic surgery.
9) People who are known to be allergic to the drug components related to this test.
10) Other subjects judged by the researchers were not suitable for inclusion.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of WOMAC joint function score between baseline and 24 weeks ± 4 days;

Secondary Outcome Measures

Name	Time	Method
SF-36 quality of life score, six minute walking distance, the difference between the baseline and the 24th week of 20 meter walking time, worms score, six values of bone markers and B-ultrasound examination of knee joint, including the changes of hydrops of suprapatellar capsule, thickness of synovium, thicknes;