Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid
NCT ID: NCT03586700
Last Updated: 2018-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2017-09-15
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Xiao zhong fang granules
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.
Xiao zhong fang granules
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.
Short wave infrared 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.
Placebo Xiao zhong fang granules
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.
Short wave infrared 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.
Placebo Xiao zhong fang granules
Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine.
Interventions
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Xiao zhong fang granules
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.
Short wave infrared 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.
Placebo Xiao zhong fang granules
Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine.
Eligibility Criteria
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Inclusion Criteria
* 2\) Kellgren/Lawrence score of knee joint grade as I,II and early III.
* 3\) According to "Principles of clinical guidance for new drugs of traditional Chinese Medicine ",diagnosed as "Xi Bi Disease".
* 4\) Patients with informed consent.
* 5)Blood and urine routine tests, liver and kidney functions, electrocardiogram were normal before recruitment.
* 6\) Patients were not treated with NSAIDS drugs or hormone drugs, and no patients were treated with drugs related to this disease at least 2 weeks.
Exclusion Criteria
* 2\) Patients with knee joint inflammatory infection, such as suppurative and nonspecific.
* 3)Patients accompanied by traumatic synovitis, Villonodular pigmented synovitis, synovial membrane of the knee is the main lesion.
* 4\) Patients with informed consent.
* 5)The color of joint fluid of patients' knees is pink or other color or cloudy; the white blood cell counts \> 1000 /mm3 or with crystal in the joint fluid.
* 6)Patients blood RF \> 30IU/ml, ESR \> 20mm/h, CRP \> 10mg/L.
* 7)Patients combined with severe cardiovascular, cerebrovascular, liver, kidney and other primary diseases and mental diseases.
ALL
No
Sponsors
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Beijing University of Chinese Medicine
OTHER
Responsible Party
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mei han
Assistant Researcher
Principal Investigators
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DUODUO LI, MASTER
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital, Beijing
Locations
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Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, Bejiing, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QN2016-03
Identifier Type: -
Identifier Source: org_study_id
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