Evidence map›Paper›PMID 32423429›Full record

ArticleTrials2020

Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study.

Kyou-Young Lee, In-Sik Han, Ho-Yeon Go, Dong-Nyung Lee, Jun-Sang Yu, Seung-Ho Sun

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Kyou-Young LeeDepartment of Ophthalmology, Otolaryngology, Dermatology, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea.
In-Sik HanDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea.
Ho-Yeon GoDepartment of Korean Internal Medicine, College of Korean Medicine, Semyung University, 65 Semyeong-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea.
Dong-Nyung LeeDepartment of Gynecology Medicine, College of Korean Medicine, Semyung University, 63 Sangbang 4-gil, Chungju-si, Chungcheongbuk-do, Republic of Korea.
Jun-Sang YuDepartment of Sasang Constitutional Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea. hiruok@sangji.ac.kr.
Seung-Ho SunDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea. sunguy2001@hanmail.net.
Sangji University · KRSemyung University · KR

Funding

Health Promotion Administration, Ministry of Health and Welfare HB1600048-010016
6 · The paper itself

Abstract

backgroundCold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal prescription for treating CHHF is Onkyeong-tang (OKT). Although OKT is widely used clinically in treating CHHF, no randomized clinical trial has been performed to evaluate the efficacy and safety of OKT in the treatment of cold hypersensitivity in the feet (CHF). This clinical trial aims to provide objective evidence for the basis of using OKT in the treatment of CHF in Korean women.

methodsThis trial will be a double-blind, randomized, placebo-controlled, parallel-group, multicenter pilot study. A total of 112 participants will be randomly divided into an OKT treatment group or a placebo group with a 1:1 ratio via a web-based randomization system. The OKT and placebo groups will receive prescribed medications orally three times per day (3 g each time) before or between meals for 8 weeks. The primary outcome studied will be the changes in Visual Analog Scale (VAS) scores of CHF from baseline. Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test. DISCUSSION: This trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial.

trial registrationClinical Research Information Service (CRIS): KCT0003723. Retrospectively registered on 8 April 2019.

Indexed as

AdultCryopyrin-Associated Periodic SyndromesDouble-Blind MethodFemaleFollow-Up StudiesFootFoot DiseasesHandHumansMedicine, Korean TraditionalMiddle AgedMulticenter Studies as TopicPhytotherapyPilot ProjectsPlant ExtractsQuality of LifePlant ExtractsCold hypersensitivityCold stress testHerbal medicineOnkyeong-tangRandomized clinical trial

Identifiers

PMID32423429
PMCPMC7236323
OpenAlexW3028517368

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.