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This study is a randomized, single blind, controlled trial. Aim to compare the effectiveness (especially the absorption degree of the synovial effusion measured by B ultrasonic) of the treatment group with the control group. The treatment group was given Xiao zhong fang granules orally and short wave infrared radiation and the control group was given the placebo Xiao zhong fang granules orally and short wave infrared radiation. To evaluate the clinical efficacy of the Chinese medicine in the treatment of the synovial effusion of knee osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiao zhong fang granules | Experimental | Xiao zhong fang granules were made from Smilax glabra 20g, Paris polyphylla 10g, Alisma orientale15g, Plantago15g, Peach kernel 10g, safflower 10g, radices cyathulae10g,fructus chaenomeles lagenaria 10g, corydalis tuber 10g, radix clematis 10g, radices paeoniae alba 10g, glycyrrhiza 10g. Granules 6 days for one course, continuously taking two courses, interval of 1 day, and then take 2 courses. Short wave infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses. |
|
| Placebo Xiao zhong fang granules | Placebo Comparator | Placebo Xiao zhong fang granules were made by the same institution. Placebo granules 6 days for one course, continuously taking two courses, interval of 1 day, and then take 2 courses. Short wave infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiao zhong fang granules | Drug | Chinese medicine Xiao zhong fang was Professor Sun Chengxiang's experience formula in Massage Department of Dongzhimen Hospital. The function of the formula is to activate blood circulation and dredge collaterals, tonifying kidney and promoting dampness to soothe the liver and nourish tendons. |
| Measure | Description | Time Frame |
|---|---|---|
| Walther grading of synovial effusion of Knee joint | The Walther grading standard of the synovial effusion of the knee joint (measuring the anterior and posterior diameter of the effusion): the 0 level is the joint cavity without effusion or the expansion of joint capsule<2mm; the grade I is a small amount of effusion, the expansion of joint capsule is 2mm-5mm; the grade II is a medium amount of effusion, the expansion of joint capsule is 6mm-10mm; the grade III is a large amount of effusion, and the joint capsule expands >10mm. | After treatment(28days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MEI HAN, PHD | Contact | 0086 13401131731 | hanmeizoujin@163.com | |
| DUODUO LI, MASTER | Contact | 0086 13671043922 | tarako@163.com |
| Name | Affiliation | Role |
|---|---|---|
| DUODUO LI, MASTER | Dongzhimen Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital Beijing University of Chinese Medicine | Recruiting | Beijing | Bejiing | 100700 | China |
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| Short wave infrared radiation | Radiation | Short waves infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses. |
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| Placebo Xiao zhong fang granules | Drug | Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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