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Zushima Plaster for Treating Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Zushima plaster with high dose
Zushima plaster with low dose
Indometacin Cataplasms
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Knee Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 40-75;
  • Unilateral or bilateral knee OA, confirmed radiographically;
  • Patients taking oral NSAIDs prior to the breakthrough period will be permitted;
  • VAS pain score is or above 20mm.

Exclusion Criteria:

  • Knee is swollen and hot;
  • Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ;
  • Congestive Heart Failure and Edema;
  • Advanced renal disease;
  • Knee joint skin is burst or skin disease or allergies.

Sites / Locations

  • Guang'anmen Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

High dose group

Low dose group

Controlled group

Arm Description

High dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 24h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 24h per day.

Low dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 12h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 12h per day.

Indometacin Cataplasms will be used topically on the knee for 24h per day

Outcomes

Primary Outcome Measures

the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment

Secondary Outcome Measures

the change of Patient's global assessment of disease activity from baseline to posttreatment
the change of WOMAC Osteoarthritis Index from baseline to posttreatment
the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status.
the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment
ESR, also called a sedimentation rate, is the rate at which red blood cells sediment in a period of one hour. It is a non-specific measure of inflammation.
the change of C-reactive protein (CRP) from baseline to posttreatment
the change of knee musculoskeletal ultrasound (MSUS) from baseline to posttreatment
MSUS had wisely using in rheumatology practice and research. MSUS includes synovitis classification, synovial hyperplasia classification, articular cavity effusion and bone erosion classification. Specific as follows: Synovitis classification: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal < 50% of the synovial membrane area; level 3 doppler signal is the synovium in > 50% of the area. Synovial hyperplasia classification: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side. Articular cavity effusion and bone erosion classification: adopt binary evaluation, namely 0: normal, 1: abnormal.

Full Information

First Posted
May 2, 2016
Last Updated
November 19, 2018
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Beijing Hospital of Traditional Chinese Medicine, Beijing Hospital, Beijing Jishuitan Hospital, Beijing Shijitan Hospital, Capital Medical University, Shanghai Municipal Hospital of Traditional Chinese Medicine, Gansu Provincial Hospital, General Hospital of Beijing Military Area
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1. Study Identification

Unique Protocol Identification Number
NCT02770950
Brief Title
Zushima Plaster for Treating Knee Osteoarthritis
Official Title
Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Beijing Hospital of Traditional Chinese Medicine, Beijing Hospital, Beijing Jishuitan Hospital, Beijing Shijitan Hospital, Capital Medical University, Shanghai Municipal Hospital of Traditional Chinese Medicine, Gansu Provincial Hospital, General Hospital of Beijing Military Area

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose group
Arm Type
Active Comparator
Arm Description
High dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 24h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 24h per day.
Arm Title
Low dose group
Arm Type
Active Comparator
Arm Description
Low dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 12h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 12h per day.
Arm Title
Controlled group
Arm Type
Active Comparator
Arm Description
Indometacin Cataplasms will be used topically on the knee for 24h per day
Intervention Type
Drug
Intervention Name(s)
Zushima plaster with high dose
Intervention Description
Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.
Intervention Type
Drug
Intervention Name(s)
Zushima plaster with low dose
Intervention Description
Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.
Intervention Type
Drug
Intervention Name(s)
Indometacin Cataplasms
Intervention Description
Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.
Primary Outcome Measure Information:
Title
the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment
Time Frame
Week 2.
Secondary Outcome Measure Information:
Title
the change of Patient's global assessment of disease activity from baseline to posttreatment
Time Frame
Week 2.
Title
the change of WOMAC Osteoarthritis Index from baseline to posttreatment
Time Frame
Week 2.
Title
the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
Description
The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status.
Time Frame
Week 2.
Title
the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment
Description
ESR, also called a sedimentation rate, is the rate at which red blood cells sediment in a period of one hour. It is a non-specific measure of inflammation.
Time Frame
Week 2.
Title
the change of C-reactive protein (CRP) from baseline to posttreatment
Time Frame
Week 2.
Title
the change of knee musculoskeletal ultrasound (MSUS) from baseline to posttreatment
Description
MSUS had wisely using in rheumatology practice and research. MSUS includes synovitis classification, synovial hyperplasia classification, articular cavity effusion and bone erosion classification. Specific as follows: Synovitis classification: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal < 50% of the synovial membrane area; level 3 doppler signal is the synovium in > 50% of the area. Synovial hyperplasia classification: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side. Articular cavity effusion and bone erosion classification: adopt binary evaluation, namely 0: normal, 1: abnormal.
Time Frame
Week 2.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 40-75; Unilateral or bilateral knee OA, confirmed radiographically; Patients taking oral NSAIDs prior to the breakthrough period will be permitted; VAS pain score is or above 20mm. Exclusion Criteria: Knee is swollen and hot; Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ; Congestive Heart Failure and Edema; Advanced renal disease; Knee joint skin is burst or skin disease or allergies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Jiang, MD. PhD.
Organizational Affiliation
Rheumatology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Zushima Plaster for Treating Knee Osteoarthritis

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