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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Xiao zhong fang granules
Short wave infrared radiation
Placebo Xiao zhong fang granules
Sponsored by
Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Synovium effusion, RCT, placebo

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dongzhimen Hospital Beijing University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xiao zhong fang granules

Placebo Xiao zhong fang granules

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2018
Last Updated
July 12, 2018
Sponsor
Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03586700
Brief Title
Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid
Official Title
Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Synovium effusion, RCT, placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xiao zhong fang granules
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Xiao zhong fang granules
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Xiao zhong fang granules
Intervention Description
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
Radiation
Intervention Name(s)
Short wave infrared radiation
Intervention Description
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
Drug
Intervention Name(s)
Placebo Xiao zhong fang granules
Intervention Description
Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine.
Primary Outcome Measure Information:
Title
Walther grading of synovial effusion of Knee joint
Description
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.
Time Frame
After treatment(28days)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MEI HAN, PHD
Phone
0086 13401131731
Email
hanmeizoujin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
DUODUO LI, MASTER
Phone
0086 13671043922
Email
tarako@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DUODUO LI, MASTER
Organizational Affiliation
Dongzhimen Hospital, Beijing University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen Hospital Beijing University of Chinese Medicine
City
Beijing
State/Province
Bejiing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DUODUO LI, MASTER
Phone
0086 10 65250460
Email
tarako@163.com
First Name & Middle Initial & Last Name & Degree
CHANGHE YU, PHD
Phone
0086 13810786345
Email
yakno2@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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