Efficacy and Safety of Shinbaro Capsule

NCT ID: NCT01535417

Last Updated: 2012-02-17

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

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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

DOUBLE

Participants Investigators

Study Groups

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GCSB

Group Type EXPERIMENTAL

Shinbaro Capsule

Intervention Type DRUG

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

Celebrex

Group Type ACTIVE_COMPARATOR

Celebrex

Intervention Type DRUG

Interventions

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Shinbaro Capsule

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

Intervention Type DRUG

Celebrex

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* had other comorbid orthopedic disease
* had OA of index knee from significant trauma or surgery
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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GCSB_P3

Identifier Type: -

Identifier Source: org_study_id

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