NCT01535417

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

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, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

7 months

First QC Date

February 12, 2012

Last Update Submit

February 14, 2012

Conditions

Osteoarthritis

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • WOMAC change

    WOMAC change

    Baseline, 12 weeks

Secondary Outcomes (3)

  • 100mm Pain VAS on walking

    Baseline, 12 weeks

  • PGART

    12 weeks

  • Adverse Events

    12 weeks

Study Arms (2)

GCSB

EXPERIMENTAL
Drug: Shinbaro Capsule

Celebrex

ACTIVE COMPARATOR
Drug: Celebrex

Interventions

Shinbaro CapsuleDRUG

Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex)

GCSB
CelebrexDRUG
Celebrex

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 35 and 80
  • diagnosed with Knee OA based on criteria of ACR and showed ont through I \~ III of Kellgren Stage on radiography
  • wuffered constantly with Knee OA for more than 6 months prior to begining the study
  • scored more than 30 on total WOMAC scale

You may not qualify if:

  • had other comorbid orthopedic disease
  • had OA of index knee from significant trauma or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

shinbaroCelecoxib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2012

First Posted

February 17, 2012

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 17, 2012

Record last verified: 2012-02