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