Clinical Trial: Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet - A Randomized, Double-blinded, Placebo Controlled, Multi-center Pilot
Brief Summary: The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on Korean Patients With Cold Hypersensitivity in the Hands
Detailed Summary:
Sponsor: Chan-Yong Jeon
Current Primary Outcome: Changes from baseline in visual analogue scale [ Time Frame: At baseline, week 4, 8, 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Changes from baseline in body temperature [ Time Frame: At baseline, week 4, 8, 12 ]
- Changes from baseline in WHOQoL-BREF [ Time Frame: At baseline, week 4, 8, 12 ]
- Changes from baseline in cold stress test [ Time Frame: At baseline, week 8 ]similar to the cold stimulation test
- Vital Sign [ Time Frame: every visit ]Body temperature, blood pressure, pulse rate
- Liver function tests [ Time Frame: At screening visit, week 8 ]Levels of AST, ALT and r-GTP
- Kidney function test [ Time Frame: At screening visit, week 8 ]Levels of BUN and Cr
- complete blood count [ Time Frame: At screening visit, week 8 ]
- Adverse event [ Time Frame: At week 4, 8, 12 ]
Original Secondary Outcome: Same as current
Information By: Gachon University Gil Oriental Medical Hospital
Dates:
Date Received: March 14, 2017
Date Started: April 2017
Date Completion: December 2018
Last Updated: March 17, 2017
Last Verified: March 2017
