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OpenTrials
Completed

NCT Number: NCT01535417

Efficacy and Safety of Shinbaro Capsule

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shinbaro Capsule

Drug

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

Celebrex

Drug

Primary outcomes

  1. WOMAC change

    Time frame: Baseline, 12 weeks

    WOMAC change

Secondary outcomes

  1. 100mm Pain VAS on walking

    Time frame: Baseline, 12 weeks

    change, percent change

  2. PGART

    Time frame: 12 weeks

  3. Adverse Events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study title

A 12 Weeks, Randomized, Double-blind, Multi-centers, Phase III Study to Evaluate the Efficacy and Safety of Shinbaro Capsule Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 17, 2012
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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