To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
164
Product name : Bosinji Granule Manufacturer : Tsumura \& Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g) Bosinji extract is composed of following proportion of ingredient Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g
placebo granule
Kyung Hee University medical center at Gangdong
Seoul, South Korea
Changes from baseline in visual analogue scale(VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
Time frame: At baseline, week 4, 8, 12
Changes from baseline in body temperature
Changes from baseline in body temperature
Time frame: At baseline, week 4, 8, 12
Changes from baseline in WHO Quality of Life-BREF
It is a international cross-culturally comparable quality of life assessment instrument. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of QoL in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
Time frame: At baseline, week 4, 8, 12
Changes from baseline in blood pressure
assess for monitoring patient safety
Time frame: up to 12 weeks
Changes from baseline in Pulse rate
assess for monitoring patient safety
Time frame: up to 12 weeks
Levels of AST
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liver function test for monitoring patient safety(IU/L)
Time frame: At screening visit, week 8
Levels of ALT
liver function test for monitoring patient safety(IU/L)
Time frame: Kidney function test for monitoring patient safety(mmol/L)
Levels of r-GTP
liver function test for monitoring patient safety(IU/L)
Time frame: Kidney function test for monitoring patient safety(mmol/L)
Levels of BUN
Kidney function test for monitoring patient safety(mmol/L)
Time frame: Kidney function test for monitoring patient safety(mmol/L)
Levels of Cr
Kidney function test for monitoring patient safety(mmol/L)
Time frame: Kidney function test for monitoring patient safety(mmol/L)
Adverse event
Time frame: At week 4, 8, 12