Zushima Plaster for Treating Knee Osteoarthritis

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Zushima plaster with high dose; Drug: Zushima plaster with low dose; Drug: Indometacin Cataplasms

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang'anmen hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment	Week 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of Patient's global assessment of disease activity from baseline to posttreatment		Week 2.
the change of WOMAC Osteoarthritis Index from baseline to posttreatment		Week 2.
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.	Week 2.
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.	Week 2.
the change of C-reactive protein (CRP) from baseline to posttreatment		Week 2.
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.	Week 2.

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Beijing Hospital; Beijing Shijitan Hospital, Capital Medical University; Gansu Provincial Hospital; Beijing Jishuitan Hospital; Beijing Hospital of Traditional Chinese Medicine; Shanghai Municipal Hospital of Traditional Chinese Medicine; General Hospital of Beijing Military Area

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin
• Other Study ID Numbers: 81758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided