Efficacy and Safety of Shinbaro Capsule

Green Cross Corporation

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Shinbaro Capsule; Drug: Celebrex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01535417

GCSB_P3

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

GCSB

Experimental group

Treatment:

Drug: Shinbaro Capsule

Celebrex

Active Comparator group

Treatment:

Drug: Celebrex