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| Name | Class |
|---|---|
| Sangji University Oriental Medical Hospital | UNKNOWN |
| Semyung University Affiliated Oriental Medical Hospital | OTHER |
| Kyunghee University Medical Center | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSGOST | Experimental | admission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule |
|
| Placebo | Placebo Comparator | admission to placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danggui-Sayuk-Ga-Osuyu-Saenggang-tang | Drug | Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in visual analogue scale | At baseline, week 2, 4, 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in body temperature | At baseline, week 2, 4, 6 | |
| Changes from baseline in clinical global impression(CGI) | At baseline, week 2, 4, 6 | |
| Changes from baseline in WHOQoL-BREF |
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Inclusion Criteria:
Female subjects aged 19 to 59 years have a complaint of CHH.
Patients must include at least one or more of the following symptoms:
Those who have 4 cm or greater of VAS CHH score;
A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
Those who can comply with all study-related procedures, medications, and evaluations;
Given a written informed consent form.
Exclusion Criteria:
We will exclude patients who have taken
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University, Gil Oriental Medicine Center | Incheon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28595610 | Derived | Ko Y, Go HY, Cho YY, Shin JH, Kim TH, Choi DJ, Lee JM, Jang JB, Song YK, Ko SG, Sun SH, Jeon CY. The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial. Trials. 2017 Jun 8;18(1):268. doi: 10.1186/s13063-017-2002-8. |
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| Kyung Hee University Hospital at Gangdong |
| OTHER |
| DongGuk University | OTHER |
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|
| Placebo: corn starch | Drug | Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd. |
|
| At baseline, week 2, 4, 6 |
| Changes from baseline in cold stress test | similar to the cold stimulation test | At baseline, week 6 |
| ID | Term |
|---|---|
| C569627 | Cold Hypersensitivity |
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| ID | Term |
|---|---|
| C000655130 | DSGOST |
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