Zushima Plaster for Treating Knee Osteoarthritis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences396 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

396

Conditions

Osteoarthritis

Interventions

Zushima plaster with high doseDRUG

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

Zushima plaster with low doseDRUG

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

Indometacin CataplasmsDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: Week 2.

Secondary Outcomes

the change of Patient's global assessment of disease activity from baseline to posttreatment

Time frame: Week 2.

the change of WOMAC Osteoarthritis Index from baseline to posttreatment

Time frame: 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.

Time frame: 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.

Time frame: Week 2.

the change of C-reactive protein (CRP) from baseline to posttreatment

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.