Evidence map›Paper›PMID 32080084›Full record

ArticleMedicine2020

Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant).

Youme Ko, Seung-Ho Sun, Ho-Yeon Go, Jin-Moo Lee, Jun-Bok Jang, Hyun-Kyung Sung, Bo-Hyoung Jang, Chan-Yong Jeon, Seong-Gyu Ko

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03790033 (Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 48% 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.

NCT03790033 phase2 / phase3completednot on this map

Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial

TypeinterventionalSponsorGachon University Gil Oriental Medical HospitalRan2018 to 2019Enrolled164ConditionsCold HypersensitivityArmsUcha-Shinki-Hwan, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 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

9 authors at 3 institutions in 1 country.

Youme KoDepartment of Science in Korean Medicine, Graduate School, Kyung Hee University, Kyungheedae-ro, Dongdaemun-gu.
Seung-Ho SunDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji University, Sangjidae-gil, Wonju-si, Gangwon-do.
Ho-Yeon GoDepartment of Korean Internal Medicine, College of Korean Medicine, Semyung University, Semyeong-ro, Jecheon-si, Chungcheongbuk-do.
Jin-Moo LeeDepartment of Korean Gynecology, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro, Dongdaemun-gu, Seoul.
Jun-Bok JangDepartment of Korean Gynecology, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro, Dongdaemun-gu, Seoul.
Hyun-Kyung SungDepartment of Pediatrics, College of Korean Medicine, Hospital of Semyung University, St. Sangbang, Chungju City, Chungcheongbuk-do.
Bo-Hyoung JangDepartment of Science in Korean Medicine, Graduate School, Kyung Hee University, Kyungheedae-ro, Dongdaemun-gu.
Chan-Yong JeonDepartment of Korean Internal Medicine, College of Korean Medicine, Gachon University, Seongnamdae-ro, Sujeong-gu, Gyeonggi-do, Republic of Korea.
Seong-Gyu KoDepartment of Science in Korean Medicine, Graduate School, Kyung Hee University, Kyungheedae-ro, Dongdaemun-gu.
Kyung Hee University · KRSemyung University · KRSangji University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCold hypersensitivity in the hands and feet (CHHF) is a common complaint in Asian female population especially in Korea. Due to the symptoms of CHHF the quality of individual's daily life can be degraded. Ucha-Shinki-Hwan (UCHA) is widely used in the treatment of various diseases including CHHF by harmonizing Yin and Yang, and improving the vitality of whole body. However, the efficacy of UCHA as a treatment option of CHHF has not been assessed in trials. Thus, we aimed to investigate the efficacy and safety of UCHA in Korean women with CHHF through this trial.

methodsThis study will be an exploratory, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Korean women aged 19 to 59 years who complaint with CHHF will be enrolled from 5 university affiliated Korean medicine hospitals. A total of 164 subjects will be randomly assigned to a treatment group (UCHA) or a placebo group at a 1:1 ratio. The subjects will receive 2.5 g of either UCHA or placebo three times a day for 8 weeks. The primary outcome will be evaluated with the visual analog scale score of CHHF. The secondary outcome measures will be changes in skin temperature in extremities as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. DISCUSSION: This study will be the first trial to explore the efficacy and safety of UCHA for CHHF patient. This will provide meaningful clinical information on herbal medicine treatment of CHHF and a clinical evidence for planning a full randomized clinical trial. DISCLOSURES AND ACKNOWLEDGMENTS: The authors report no competing interests.

trial registrationThis study is registered at ClinicalTrials.gov, ID: NCT03790033. Registered on (31 December 2018) PROTOCOL VERSION:: The final approved version of the trial protocol is V1.3. (25 January 2019).

Indexed as

AdultCryopyrin-Associated Periodic SyndromesDouble-Blind MethodFemaleFootHandHerbal MedicineHumansMedicine, Korean TraditionalMiddle AgedMulticenter Studies as TopicPhytotherapyPlacebosQuality of LifeRandomized Controlled Trials as TopicRepublic of KoreaPlacebos

Identifiers

PMID32080084
PMCPMC7034626
OpenAlexW3008919773

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.