Clinical Trial: Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands

Brief Summary: The Purpose of this trial is to investigate the efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang(DSGOST) on Korean Patients With Cold Hypersensitivity in the Hands

Detailed Summary:
Sponsor: Gachon University Gil Oriental Medical Hospital

Current Primary Outcome: Changes from baseline in visual analogue scale [ Time Frame: At baseline, week 2, 4, 6 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes from baseline in body temperature [ Time Frame: At baseline, week 2, 4, 6 ]
  • Changes from baseline in clinical global impression(CGI) [ Time Frame: At baseline, week 2, 4, 6 ]
  • Changes from baseline in WHOQoL-BREF [ Time Frame: At baseline, week 2, 4, 6 ]
  • Changes from baseline in cold stress test [ Time Frame: At baseline, week 6 ]
    similar to the cold stimulation test


Original Secondary Outcome:

  • Changes from baseline in body temperature [ Time Frame: At baseline, week 2, 4, 6 ]
  • Changes from baseline in clinical global impression(CGI) [ Time Frame: At baseline, week 2, 4, 6 ]
  • Changes from baseline in WHOQoL-BREF [ Time Frame: At baseline, week 2, 4, 6 ]
  • Changes from baseline in cold stress test [ Time Frame: At baseline, week 6 ]
    similar to the cold stimulation test
  • Vital Sign [ Time Frame: At baseline, week 6 ]
    Body temperature, blood pressure, pulse rate
  • Liver function tests [ Time Frame: At baseline, week 6 ]
    Levels of AST, ALT and r-GTP
  • Kidney function test [ Time Frame: At baseline, week 6 ]
    Levels of BUN and Cr
  • complete blood count [ Time Frame: At baseline, week 6 ]


Information By: Gachon University Gil Oriental Medical Hospital

Dates:
Date Received: December 30, 2015
Date Started: December 2015
Date Completion: August 2018
Last Updated: March 14, 2017
Last Verified: March 2017