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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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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OJS group | Experimental | admission to Ojeok-san granule |
|
| Placebo Group | Placebo Comparator | admission to placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ojeok-San | 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 4, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in body temperature | At baseline, week 4, 8, 12 | |
| Changes from baseline in WHOQoL-BREF | At baseline, week 4, 8, 12 | |
| Changes from baseline in cold stress test |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern Identification Questionnaire | This questionnaire is a traditional medicine researcher self-developed questionnaire for collecting general symptoms of patients with Cold Hypersensitivity in the Hands and feet | At screening visit |
| Cold Hypersensitivity diagnostic tool |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Chanyong Jeon, PhD | Gachon University Gil Oriental Medical Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee university medical center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30497488 | Derived | Ko Y, Go HY, Han IS, Lee KY, Kim TH, Lee JM, Jang JB, Song YK, Sun SH, Jeon CY, Ko SG. Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study. Trials. 2018 Nov 29;19(1):662. doi: 10.1186/s13063-018-3013-9. |
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| ID | Term |
|---|---|
| C569627 | Cold Hypersensitivity |
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| ID | Term |
|---|---|
| C587280 | ojeok-san |
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Placebo | Drug | Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd. |
|
|
similar to the cold stimulation test |
| At baseline, week 8 |
| Vital Sign | Body temperature, blood pressure, pulse rate | every visit |
| Liver function tests | Levels of AST, ALT and r-GTP | At screening visit, week 8 |
| Kidney function test | Levels of BUN and Cr | At screening visit, week 8 |
| complete blood count | At screening visit, week 8 |
| Adverse event | At week 4, 8, 12 |
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 |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |