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

Phase 2

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Xiao zhong fang granules; Radiation: Short wave infrared radiation; Drug: Placebo Xiao zhong fang granules

• Registration Number: NCT03586700
• Lead Sponsor: Beijing University of Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2018-05-25
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study First Posted: 2018-07-16
• Last Update Posted: 2018-07-16
• Primary Completion: 2020-08-31
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xiao zhong fang granules	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	Short wave infrared radiation	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	Short wave infrared radiation	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.
Placebo Xiao zhong fang granules	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.

Primary Outcome Measures

Name	Time	Method
Walther grading of synovial effusion of Knee joint	After treatment(28days)	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.

Trial Locations

Locations (1)

Dongzhimen Hospital Beijing University of Chinese Medicine; 🇨🇳 Beijing, Bejiing, China