A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule

Green Cross Corporation

Status: Unknown

Conditions: Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02064634

GCSB_OS

Details and patient eligibility

About

This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.

Enrollment: 6,700 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum 20- year-old patients diagnosed with osteoarthritis
• Within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the Shinbaro Capsule, Celecoxib Capsule and NSAIDs(non-steroidal anti-inflammatory drugs)
• Written consent form voluntarity

Exclusion criteria

• Diagnosed with disease that may affect measurement of efficacy clinically
• Diagnosed with clinically significant phycological disorder, and taking medication
• Participated in a clinical trial within 4 weeks
• Pregnant or lactating woman
• History of malignant disease within the previous 5 years
• Patients who seem not to participate in the study at investigator's discretion

Trial design

6,700 participants in 4 patient groups

Shinbaro (only)

Celecoxib (only)

Shinbaro + NSAIDs

Shinbaro + Celecoxib