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

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ClinicalTrials.gov Identifier: NCT03586700
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
mei han, 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Xiao zhong fang granules Radiation: Short wave infrared radiation Drug: Placebo Xiao zhong fang granules Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. Walther grading of synovial effusion of Knee joint [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586700


Contacts
Contact: MEI HAN, PHD 0086 13401131731 hanmeizoujin@163.com
Contact: DUODUO LI, MASTER 0086 13671043922 tarako@163.com

Locations
China, Bejiing
Dongzhimen Hospital Beijing University of Chinese Medicine Recruiting
Beijing, Bejiing, China, 100700
Contact: DUODUO LI, MASTER    0086 10 65250460    tarako@163.com   
Contact: CHANGHE YU, PHD    0086 13810786345    yakno2@163.com   
Sponsors and Collaborators
Beijing University of Chinese Medicine
Investigators
Principal Investigator: DUODUO LI, MASTER DONGZHIMEN HOSPITAL BEIJING UNIVERSITY OF CHINESE MEDICINE

Responsible Party: mei han, Assistant Researcher, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03586700     History of Changes
Other Study ID Numbers: QN2016-03
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by mei han, Beijing University of Chinese Medicine:
Knee Osteoarthritis
Synovium effusion
RCT
placebo

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases