Evidence map›Paper›PMID 32000419›Full record

ArticleMedicine2020

A pilot study exploring the efficacy and safety of herbal medicine on Korean obese women with metabolic syndrome risk factors: Double blinded, randomized, multicenter, placebo controlled study protocol clinical trial.

Hyun-Ju Kim, Youme Ko, Hojun Kim, Yun-Yeop Cha, Bo-Hyoung Jang, Yun-Kyung Song, 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 NCT02651454 (A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial -), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 51% 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.

NCT02651454 phase4completednot on this map

A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial -

TypeinterventionalSponsorGachon University Gil Oriental Medical HospitalRan2015 to 2020Enrolled120ConditionsMetabolic Syndrome, ObesityArmsDaesiho-tang, Chowiseungcheng-tang, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

7 authors at 4 institutions in 1 country.

Hyun-Ju KimOriental Medicine Research Institute, College of Korean Medicine, Gachon University, Seong-nam-si.
Youme KoDepartment of Korean Preventive Medicine, Graduate School.
Hojun KimDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Dongguk University, Seoul.
Yun-Yeop ChaDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Sang-ji University, Wonju.
Bo-Hyoung JangDepartment of Korean Preventive Medicine, Graduate School.
Yun-Kyung SongDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Gachon University, Seongnam-si, Republic of Korea.
Seong-Gyu KoDepartment of Korean Preventive Medicine, Graduate School.
Kyung Hee University · KRDongguk University · KRGachon University · KRSangji University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObesity is associated with metabolic syndrome, a condition that increases one's risk for heart disease and other conditions. The prevalence of obesity and associated diseases have steadily increased among Korean adults. The effect of the herbal medicines Daesiho-tang (DSHT) and Chowiseungcheng-tang (CST) on obesity have been reported. The purpose of this study is to evaluate the efficacy and safety of Daesiho-tang and Chowiseungcheng-tang on obese Korean women with high risk for metabolic syndrome. METHODS/

designThis study is a randomized, double-blinded, placebo-controlled, multi-center, 3-arm, parallel group clinical trial. A total of 120 participants will be enrolled and randomly assigned to the Daesiho-tang group, the Chowiseungcheng-tang group, or the placebo group in a 1:1:1 ratio using an internet-based randomization system at visit 2. Each group will be administered DSHT, CST, or placebo 3 times per day for 12 weeks. The primary outcome is to evaluate the changes in mean body weight of participants in the DSHT and CST groups and compare with those in the placebo group, and determine their statistical significance, if any, after 12 weeks. The secondary outcomes are the following: changes in body fat percentage and body fat mass, changes in waist circumference, waist-to-hip ratio, and body mass index, changes in serum lipids, fasting blood sugar, blood pressure, and C-reactive proteins (CRP) levels between visit 1 and visit 5 measurements. Changes in visceral fat volume determined through abdominal computed tomography, patient-reported health outcomes surveys-the Korean version of the Obesity-related Quality of Life and the Korean version of Eating Attitudes Test. DISCUSSION: This study will provide research methodologies for evaluating the efficacy and safety of Daesiho-tang and Chowiseungcheng-tang on obese Korean women with high risk for metabolic syndrome.

trial registrationClinicalTrials.gov, NCT02651454. Registered on 11 January 2016.Protocol version: The final approved version of the trial protocol is V1.3.(2017.11.10).

Indexed as

Medicine, Korean TraditionalMulticenter Studies as TopicPhytotherapyRandomized Controlled Trials as TopicAdolescentAdultAgedAnti-Obesity AgentsFemaleHumansMetabolic SyndromeMiddle AgedObesityPatient SelectionPilot ProjectsRepublic of KoreaAnti-Obesity Agents

Identifiers

PMID32000419
PMCPMC7004663
OpenAlexW3003525623

What OpenQuestion holds

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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.