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Zushima Plaster for Treating Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02770950
Recruitment Status : Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Beijing Hospital of Traditional Chinese Medicine
Beijing Hospital
Beijing Jishuitan Hospital
Beijing Shijitan Hospital
Shanghai Municipal Hospital of Traditional Chinese Medicine
Gansu Provincial Hospital
General Hospital of Beijing Military Area
Information provided by (Responsible Party):
Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Zushima plaster with high dose Drug: Zushima plaster with low dose Drug: Indometacin Cataplasms Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research
Study Start Date : May 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: High dose group

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.

Drug: Zushima plaster with high dose
Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.
Active Comparator: Low dose group

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.

Drug: Zushima plaster with low dose
Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.
Active Comparator: Controlled group
Indometacin Cataplasms will be used topically on the knee for 24h per day
Drug: Indometacin Cataplasms
Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.



Primary Outcome Measures :
  1. the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment [ Time Frame: Week 2. ]

Secondary Outcome Measures :
  1. the change of Patient's global assessment of disease activity from baseline to posttreatment [ Time Frame: Week 2. ]
  2. the change of WOMAC Osteoarthritis Index from baseline to posttreatment [ Time Frame: Week 2. ]
  3. the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment [ Time Frame: Week 2. ]
    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.

  4. the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment [ Time Frame: Week 2. ]
    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.

  5. the change of C-reactive protein (CRP) from baseline to posttreatment [ Time Frame: Week 2. ]
  6. the change of knee musculoskeletal ultrasound (MSUS) from baseline to posttreatment [ Time Frame: Week 2. ]
    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.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02770950


Locations
China, Beijing
Guang'anmen Hospital
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing Hospital of Traditional Chinese Medicine
Beijing Hospital
Beijing Jishuitan Hospital
Beijing Shijitan Hospital
Shanghai Municipal Hospital of Traditional Chinese Medicine
Gansu Provincial Hospital
General Hospital of Beijing Military Area
Investigators
Principal Investigator: Quan Jiang, MD. PhD. Rheumatology Department

Responsible Party: Juan Jiao, Attending Doctor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02770950     History of Changes
Other Study ID Numbers: 81758
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Knee Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action