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OpenTrials
Completed

NCT Number: NCT01604239

To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis

This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyungpook national university hospital, Daegu, Kyungpook, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Minimum 19 years old
  • Kellgren stage I ~ III by ACR criteria
  • Stable osteoarthritis during 3 months
  • Be able to perform WOMAC and KKS
  • Written consent form voluntarily

Exclusion criteria

  • Disease of orthopaedic surgical that could affect to evaluate the efficacy
  • Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
  • Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks
  • Medical history of hypersensitivity reaction against Herbal drug
  • Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc.
  • Occurrence of OA caused by the injury
  • Diagnosed with psychical disorder, and taking medication
  • Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases
  • Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
  • Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
  • Positive in fecal occult blood test
  • Gastrointestinal tract surgery except appendectomy
  • Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
  • Participation in another clinical trials within 4 weeks
  • Not consent about using effectual contraception method during trial
  • Pregnant or lactating woman
  • Medical history of malignant tumor within 5 years
  • Investigator's judgment

Treatment and study plan

Shinbaro Capsule

Drug

600mg twice a day (b.i.d) oral herbal medicine

Primary outcomes

  1. Percentage of subjects with gastrointestinal adverse events

    Time frame: Baseline through 24 weeks

Secondary outcomes

  1. percentage of subjects with perforation, ulcer, bleeding

    Time frame: baseline throgh week 24

  2. percentage of subjects who withdrew due to GI AEs

    Time frame: baseline through week 24

  3. Frequency of AEs

    Time frame: baseline throgh week 24

  4. WOMAC change from baseline

    Time frame: 24 weeks

  5. KKS (Korean Knee Score) change from baseline

    Time frame: 24 weeks

  6. 100mm pain VAS on walking

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study title

A 24 Weeks, Multi-centers, Single Arm Phase IV Study to Evaluate the Safety of 'Shinbaro Capsule' Compared With Historical Data of 'Celebrex Capsule' in Patients With Osteoarthritis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 23, 2012
Registry last updated
Nov 13, 2013

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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