Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid

Knee Osteoarthritis Clinical Trial

Official title:

Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03586700
• Other study ID #: QN2016-03
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: July 2018
• Source: Beijing University of Chinese Medicine
• Contact: MEI HAN, PHD
• Phone: 0086 13401131731
• Email: hanmeizoujin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1) the American Society of Rheumatology established the diagnostic criteria for knee OA in 2001;

• 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:

• 1)Patients suffer from other rheumatic and metabolic diseases such as gout, rheumatoid arthritis, diabetes and so on.

• 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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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.

Radiation:
• 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.

Drug:
• Placebo Xiao zhong fang granules
Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine.

Locations

Country	Name	City	State
China	Dongzhimen Hospital Beijing University of Chinese Medicine	Beijing	Bejiing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)