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

Beijing University of Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Radiation: Short wave infrared radiation; Drug: Xiao zhong fang granules; Drug: Placebo Xiao zhong fang granules

Study type: Interventional

Funder types: Other

Identifiers

NCT03586700

QN2016-03

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

Xiao zhong fang granules

Experimental group

Description:

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.

Treatment:

Drug: Xiao zhong fang granules

Radiation: Short wave infrared radiation

Placebo Xiao zhong fang granules

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Xiao zhong fang granules

Radiation: Short wave infrared radiation