RESUMO
Objective:To evaluate the clinical efficacy and safety ofHJ-RY-1 therapeutic pad ofsoft stone in treating osteoarthritis.Methods:Patients with osteoarthritis with syndrome ofqi stagnancy and blood stasis were enrolled according to the diagnostic criteria and the evaluation standard ofcurative effect in Instruction Principle ofClinical Research ofNew Chinese Medicines, and were randomly divided into experimental group(treating by HJ-RY-1 therapeutic pad ofsoft stone) and the control group(treating by the paster offar infrared bioactive ceramics).Put them respectively on the afflicted part for more than 12 hours a day, and the treatment course ofboth groups lasted 14 days.The main turnover was determined by the improvement of6 clinical parameter indices and the incidence rate ofwhole curative effect and side effect after a treatment of7 days and 14 days.Results:72 patients were randomly equally divided into two groups, and received predetermined interveneing therapy.There were similar baseline characteristics and comparabilities between them.Totally 68 patients finished 2 weeks follow-up observation and 4 cases were missed(33/36 in experimental group;35/36 in the control group).1 weeks later, there were no significant difference in clinical situation and overall curative effect between two groups.But after two weeks interveneing therapy, there were significant difference on activity pain(t-value was 3.3104), the joint movement range(t-value was 3.1596), self-sensation(t-value was 2.5521) and overall curative effect(t-value was 3.5694) between them(P