Evidence map›Paper›PMID 32664064›Full record

ArticleMedicine2020

Safety and efficacy of an herbal formula, Gwakhyangjeonggi-san on atopic dermatitis with gastrointestinal symptoms: Protocol for a randomized controlled trial.

Mi Ju Son, Min Hee Kim, Minseo Kang, Young-Eun Kim, Jeeyoun Jung, Inhwa Choi

Open 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. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 32% 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, 3 citations in OpenAlex.

  1. Review
  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 2 countries.

Mi Ju SonClinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon.ORCID 0000-0003-1701-9122
Min Hee KimDepartment of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul.
Minseo KangDepartment of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul.
Young-Eun KimFuture Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Jeeyoun JungClinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon.
Inhwa ChoiDepartment of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul.
Korea Institute of Oriental Medicine · KRKyung Hee University Hospital at Gangdong · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGwakhyangjeonggi-san (GJS) is an herbal formula with anti-inflammatory and anti-allergic properties that is broadly used to treat a wide range of diseases including gastrointestinal disorders and allergic diseases. There have been several clinical studies conducted on its effects on atopic dermatitis (AD). So far, no randomized controlled trials have been conducted. Here, we describe the protocol for a randomized controlled study designed to investigate the efficacy and safety of GJS for treating patients with AD that have gastrointestinal symptoms. METHODS AND ANALYSIS: A randomized, double-blind, placebo-controlled, parallel-group, clinical trial has been designed to investigate the clinical efficacy and safety of GJS on patients with AD that have gastrointestinal symptoms. A total of 58 participants with AD will be recruited and randomly allocated to the GJS or placebo group in a 1:1 ratio. The participants will be administered GJS or placebo granules 3 times a day for 8 weeks. Data will be collected from the participants at baseline and after 4 and 8 weeks. The primary outcome measure will be the mean change in the SCORing of Atopic Dermatitis (SCORAD) index from baseline to 8 weeks. The secondary outcomes will include the eczema area and severity index (EASI), dermatology life quality index (DLQI), EuroQoL 5 dimensions 5 levels (EQ-5D-5L), and immunological factors. The Korean Gastrointestinal Symptom Rating Scale (KGSRS), Nepean Dyspepsia Index will also be obtained for assessing the gastrointestinal status. DISCUSSION: The findings of this study are expected to provide evidence on the safety and effectiveness of GJS and for treating patients with AD that have gastrointestinal symptoms. Additionally, the study will explore the mechanism of GJS action via gut microbiome. This study will provide new perspectives on approaching treatment for AD. ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital at Gangdong (KHNMCOH2019-06-002-001). TRIAL REGISTRATION NUMBER: This study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004299).

Indexed as

Dermatitis, AtopicDouble-Blind MethodDrugs, Chinese HerbalGastrointestinal DiseasesGastrointestinal MicrobiomeHumansPhytotherapyRandomized Controlled Trials as TopicDrugs, Chinese Herbalgwakhyangjeonggi-san

Identifiers

PMID32664064
PMCPMC7360236
OpenAlexW3041980618

What OpenQuestion holds

Textmetadata
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.