Zushima Plaster for Treating Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770950
• Other study ID #: 81758
• Status: Completed
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• Zushima plaster with low dose
Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.
• Indometacin Cataplasms
Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing Hospital, Beijing Hospital of Traditional Chinese Medicine, Beijing Jishuitan Hospital, Beijing Shijitan Hospital, Gansu Provincial Hospital, General Hospital of Beijing Military Area, Shanghai Municipal Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment		Week 2.
Secondary	the change of Patient's global assessment of disease activity from baseline to posttreatment		Week 2.
Secondary	the change of WOMAC Osteoarthritis Index from baseline to posttreatment		Week 2.
Secondary	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.
Secondary	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.
Secondary	the change of C-reactive protein (CRP) from baseline to posttreatment		Week 2.
Secondary	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.