Efficacy and Safety of Shinbaro Capsule

Green Cross Corporation198 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

198

Conditions

Osteoarthritis

Interventions

Shinbaro CapsuleDRUG

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

CelebrexDRUG

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

WOMAC change

Time frame: Baseline, 12 weeks

Secondary Outcomes

100mm Pain VAS on walking

change, percent change

Time frame: Baseline, 12 weeks

PGART

Time frame: 12 weeks

Adverse Events

Time frame: 12 weeks

Data from ClinicalTrials.gov

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