NCT02770950

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

May 2, 2016

Last Update Submit

November 19, 2018

Conditions

Osteoarthritis

Keywords

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

    Week 2.

Secondary Outcomes (6)

  • 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

    Week 2.

  • the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment

    Week 2.

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

    Week 2.

  • +1 more secondary outcomes

Study Arms (3)

High dose group

ACTIVE COMPARATOR

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

Low dose group

ACTIVE COMPARATOR

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

Controlled group

ACTIVE COMPARATOR

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

Drug: Indometacin Cataplasms

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.

High dose group
Zushima plaster with low doseDRUG

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

Low dose group
Indometacin CataplasmsDRUG

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

Controlled group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Quan Jiang, MD. PhD.

    Rheumatology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Doctor

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 12, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations

CN(1)