Zushima Plaster for Treating Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Zushima plaster with high dose

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Zushima plaster with low dose

Intervention Type DRUG

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

Controlled group

Indometacin Cataplasms will be used topically on the knee for 24h per day

Group Type ACTIVE_COMPARATOR

Indometacin Cataplasms

Intervention Type DRUG

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

Interventions

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Zushima plaster with high dose

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

Intervention Type 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.

Intervention Type DRUG

Indometacin Cataplasms

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No