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Completed

NCT Number: NCT02770950

Zushima Plaster for Treating Knee Osteoarthritis

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

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zushima plaster with high dose

Drug

Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.

Zushima plaster with low dose

Drug

Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.

Indometacin Cataplasms

Drug

Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.

Primary outcomes

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

    Time frame: Week 2.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • Beijing Hospital
  • Beijing Hospital of Traditional Chinese Medicine
  • Beijing Jishuitan Hospital
  • Beijing Shijitan Hospital, Capital Medical University
  • Gansu Provincial Hospital
  • General Hospital of Beijing Military Area
  • Shanghai Municipal Hospital of Traditional Chinese Medicine

Registry information

Official study title

Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 12, 2016
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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