Evidence map›Paper›PMID 30497488›Full record

ArticleTrials2018

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.

Youme Ko, Ho-Yeon Go, In-Sik Han, Kyou-Young Lee, Tae-Hoon Kim, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seung-Ho Sun, Chan-Yong Jeon and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03083522 (Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet - A Randomized, Double-blinded, Placebo Controlled, Multi-center Pilot Study), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT03083522 phase3completednot on this map

Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet - A Randomized, Double-blinded, Placebo Controlled, Multi-center Pilot Study

TypeinterventionalSponsorChan-Yong JeonRan2017 to 2019Enrolled60ConditionsCold HypersensitivityArmsOjeok-San, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Frontiers in pharmacology · 2021
    Article
  6. 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

11 authors.

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.
In-Sik HanDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, 26339, Republic of Korea.
Kyou-Young LeeDepartment 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.
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 clinical trial center, College of Korean Medicine, Kyung Hee University Hospital, 23 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.
Seung-Ho SunDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, 26339, Republic of Korea. sunguy2001@hanmail.net.
Chan-Yong JeonDepartment of Korean Internal Medicine, College of Korean Medicine, Gachon University, 1342 Seongnamdae-ro, Sujeong-gu, Gyeonggi-do, Republic of Korea. joncy@gachon.ac.kr.
Seong-Gyu KoDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.

Funding

Ministry of Health and Welfare HI13C0530
6 · The paper itself

Abstract

backgroundThis 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.

methodsThis 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 registrationClinicalTrials.gov, ID: NCT03083522 . Registered on 20 March 2017.

Indexed as

AdultBody Temperature RegulationCold TemperatureCryopyrin-Associated Periodic SyndromesDouble-Blind MethodFemaleFootHandHumansMiddle AgedMulticenter Studies as TopicPain MeasurementPilot ProjectsPlant ExtractsQuality of LifeRandomized Controlled Trials as Topicojeok-sanPlant ExtractsCold hypersensitivityCold temperatureHerbal medicineKorean medicineRandomized clinical trial

Identifiers

PMID30497488
PMCPMC6267068

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.