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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-10-31

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Xiao zhong fang granules

Intervention Type DRUG

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

Intervention Type 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.

Group Type PLACEBO_COMPARATOR

Short wave infrared radiation

Intervention Type 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

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type RADIATION

Placebo Xiao zhong fang granules

Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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mei han

Assistant Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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MEI HAN, PHD

Role: CONTACT

0086 13401131731

DUODUO LI, MASTER

Role: CONTACT

0086 13671043922

Facility Contacts

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DUODUO LI, MASTER

Role: primary

0086 10 65250460

CHANGHE YU, PHD

Role: backup

0086 13810786345

Other Identifiers

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QN2016-03

Identifier Type: -

Identifier Source: org_study_id

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