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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Ko, Youme Go, Ho-Yeon Han, In-Sik Lee, Kyou-Young Kim, Tae-Hoon Lee, Jin-Moo Jang, Jun-Bok Song, Yun-Kyung Sun, Seung-Ho Jeon, Chan-Yong Ko, Seong-Gyu |
| Abstract | Background This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet. Methods This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an Internet-based randomization system. Each group will be administered Ojeok-san or placebo three times per day for 8 weeks. The primary outcome will be the mean change in the Visual Analog Scale scores of cold hypersensitivity in the hands from baseline to week 8. Secondary outcomes will include the mean changes in the skin temperature of the extremities, recovery rate of the skin temperature of hands after cold stress test, and the score of Korean version of the WHO Quality of Life Scale abbreviated version. Discussion The findings of this study should provide meaningful information for a further large-scale, randomized controlled trial to confirm the safety and efficacy of Ojeok-san on cold hypersensitivity in the hands and feet in female patients. Trial registration ClinicalTrials.gov, ID: NCT03083522 . Registered on 20 March 2017. |
| Related Links | https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-018-3013-9.pdf |
| Ending Page | 8 |
| Page Count | 8 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 17456215 |
| DOI | 10.1186/s13063-018-3013-9 |
| Journal | Trials |
| Issue Number | 1 |
| Volume Number | 19 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2018-11-29 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Herbal medicine Cold temperature Cold hypersensitivity Randomized clinical trial Korean medicine Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Pharmacology (medical) |
| Journal Impact Factor | 2/2023 |
| 5-Year Journal Impact Factor | 2.1/2023 |
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