Evidence map›Paper›PMID 28595610›Full record

Trial reportTrials2017

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.

Youme Ko, Ho-Yeon Go, Yoon-Young Cho, Ji-Hye Shin, Tae-Hoon Kim, Dong-Jun Choi, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seong-Gyu Ko and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02645916 (Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT02645916 phase4completednot on this map

Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands

TypeinterventionalSponsorGachon University Gil Oriental Medical HospitalRan2015 to 2017Enrolled66ConditionsCold HypersensitivityArmsDanggui-Sayuk-Ga-Osuyu-Saenggang-tang, Placebo: corn starch
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
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  3. Review
  4. Article
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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

12 authors at 5 institutions in 1 country.

Youme KoDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 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.
Yoon-Young ChoDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80, Sangjidae-gil, Wonju-si, Gangwon-do, 26339, Republic of Korea.
Ji-Hye ShinDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80, Sangjidae-gil, Wonju-si, Gangwon-do, 26339, Republic of Korea.
Tae-Hoon KimDepartment of Clinical Trial Center, College of Korean Medicine, Kyung Hee University Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.
Dong-Jun ChoiDepartment of Korean Internal Medicine, College of Korean Medicine, Dongguk University, 814 Siksa-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea.
Jin-Moo LeeDepartment of Korean Gynecology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.
Jun-Bok JangDepartment of Korean Gynecology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.
Yun-Kyung SongDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Gachon University, 1342 Seongnamdae-ro, Sujeong-gu, Gyeonggi-do, Republic of Korea.
Seong-Gyu KoDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.
Seung-Ho SunDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80, Sangjidae-gil, Wonju-si, Gangwon-do, 26339, Republic of Korea. isee9278@gmail.com.
Chan-Yong JeonDepartment of Korean Internal Medicine, College of Korean Medicine, Gachon University, 1342 Seongnamdae-ro, Sujeong-gu, Gyeonggi-do, 13120, Republic of Korea. joncy@gachon.ac.kr.
Kyung Hee University · KRSangji University · KRGachon University · KRDongguk University · KRSemyung University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn recent years, cold hypersensitivity in the hands (CHH) has become a common ailment of women in Korea. It can lead to gynecological problems such as irregular menstruation, miscarriage, and infertility. Traditionally, Korean herbal medicine has been the primary treatment method used to balance thermoregulation in the human body; however, its effectiveness has not been confirmed through systematic study. Thus, in this trial, we will investigate the feasibility of a full randomized clinical trial, Danggui-Sayuk-Ga-Osuyu-Saenggang-tang (DSGOST) in Korean women with CHH.

methodsThis study will be a pilot, multicenter, double-blind, randomized, parallel-group, two-arm, placebo-controlled clinical trial. A total of 66 participants will be randomly divided into two groups, a DSGOST treatment group and a placebo control group, in a 1:1 ratio using a web-based randomization system. Each group will take DSGOST or placebo three times daily for 6 weeks. The primary outcome will be measured using Visual Analogue Scale (VAS) scores of CHH. Secondary outcomes will include changes in skin temperature of the hands, Clinical Global Impressions (CGI) scale scores, recovery rate of skin temperature of the hands after the cold stress test, and the Korean version of the WHO Quality of Life Scale, abbreviated version (WHOQOL-BREF). DISCUSSION: This trial will be the first trial to reflect the newly defined disease range of CHH which was compiled by Korean medicine expert consensus. This study will provide considerable evidence for further large-scale trials and general clinical guidelines for CHH in the Korean medical field.

trial registrationThis study is registered at ClinicalTrials.gov, ID: NCT02645916 . Registered on 30 December 2015.

Indexed as

AdultClinical ProtocolsCryopyrin-Associated Periodic SyndromesDouble-Blind MethodDrugs, Chinese HerbalFeasibility StudiesFemaleHumansMiddle AgedPilot ProjectsQuality of LifeRepublic of KoreaResearch DesignSeverity of Illness IndexSkin TemperatureTime FactorsDrugs, Chinese HerbalCold hypersensitivityCold temperatureHerbal medicineRandomized clinical trial

Identifiers

PMID28595610
PMCPMC5465469
OpenAlexW2622654981

What OpenQuestion holds

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Registered trials

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.