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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Kyung Hee university medical center
Seoul, South Korea
Changes from baseline in visual analogue scale
Time frame: At baseline, week 4, 8, 12
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
similar to the cold stimulation test
Time frame: At baseline, week 8
Vital Sign
Body temperature, blood pressure, pulse rate
Time frame: every visit
Liver function tests
Levels of AST, ALT and r-GTP
Time frame: At screening visit, week 8
Kidney function test
Levels of BUN and Cr
Time frame: At screening visit, week 8
complete blood count
Time frame: At screening visit, week 8
Adverse event
Time frame: At week 4, 8, 12
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