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| Name | Class |
|---|---|
| Kyunghee University Medical Center | OTHER |
| Kyung Hee University Hospital at Gangdong | OTHER |
| Semyung University Affiliated Oriental Medical Hospital | OTHER |
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To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCHA group | Experimental | 2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company |
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| Placebo group | Placebo Comparator | 2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ucha-Shinki-Hwan | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, week 4, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in body temperature | Changes from baseline in body temperature | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern Identification Questionnaire | This tool is a traditional medicine researcher self-developed questionnaire of screening for patients with Cold Hypersensitivity in the Hands and feet In this trial, we will assess the validity of the tool. | At screening visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chan Yong Jun | Gachon University Gil Oriental Medicine Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University medical center at Gangdong | Seoul | 02447 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32080084 | Derived | Ko Y, Sun SH, Go HY, Lee JM, Jang JB, Sung HK, Jang BH, Jeon CY, Ko SG. Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19110. doi: 10.1097/MD.0000000000019110. |
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| Sangji University Oriental Medical Hospital |
| UNKNOWN |
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| Placebo | Drug | placebo granule |
|
| At baseline, week 4, 8, 12 |
| Changes from baseline in blood pressure | assess for monitoring patient safety | up to 12 weeks |
| Changes from baseline in Pulse rate | assess for monitoring patient safety | up to 12 weeks |
| Levels of AST | liver function test for monitoring patient safety(IU/L) | At screening visit, week 8 |
| Levels of ALT | liver function test for monitoring patient safety(IU/L) | Kidney function test for monitoring patient safety(mmol/L) |
| Levels of r-GTP | liver function test for monitoring patient safety(IU/L) | Kidney function test for monitoring patient safety(mmol/L) |
| Levels of BUN | Kidney function test for monitoring patient safety(mmol/L) | Kidney function test for monitoring patient safety(mmol/L) |
| Levels of Cr | Kidney function test for monitoring patient safety(mmol/L) | Kidney function test for monitoring patient safety(mmol/L) |
| Adverse event | At week 4, 8, 12 |
| ID | Term |
|---|---|
| C569627 | Cold Hypersensitivity |
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