Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 knee-osteoarthritis
Started Sep 2017
Typical duration for phase_2 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2017
CompletedFirst Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedJuly 16, 2018
July 1, 2018
3 years
May 25, 2018
July 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Xiao zhong fang granules
EXPERIMENTALXiao 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 COMPARATORPlacebo 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.
Interventions
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 waves infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses.
Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine.
Eligibility Criteria
You may qualify if:
- \) the American Society of Rheumatology established the diagnostic criteria for knee OA in 2001;
- \) Kellgren/Lawrence score of knee joint grade as I,II and early III.
- \) According to "Principles of clinical guidance for new drugs of traditional Chinese Medicine ",diagnosed as "Xi Bi Disease".
- \) Patients with informed consent.
- )Blood and urine routine tests, liver and kidney functions, electrocardiogram were normal before recruitment.
- \) 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.
You may not qualify if:
- )Patients suffer from other rheumatic and metabolic diseases such as gout, rheumatoid arthritis, diabetes and so on.
- \) Patients with knee joint inflammatory infection, such as suppurative and nonspecific.
- )Patients accompanied by traumatic synovitis, Villonodular pigmented synovitis, synovial membrane of the knee is the main lesion.
- \) Patients with informed consent.
- )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.
- )Patients blood RF \> 30IU/ml, ESR \> 20mm/h, CRP \> 10mg/L.
- )Patients combined with severe cardiovascular, cerebrovascular, liver, kidney and other primary diseases and mental diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, Bejiing, 100700, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
DUODUO LI, MASTER
Dongzhimen Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Researcher
Study Record Dates
First Submitted
May 25, 2018
First Posted
July 16, 2018
Study Start
September 15, 2017
Primary Completion
August 31, 2020
Study Completion
October 31, 2020
Last Updated
July 16, 2018
Record last verified: 2018-07