Evidence map›Paper›PMID 29924041›Full record

Trial reportMedicine2018

Safety and efficacy of Galgeun-tang-ga-cheongung-sinyi, a herbal formula, for the treatment of chronic rhinosinusitis: A study protocol for a randomized controlled trial.

Mi Ju Son, Ojin Kwon, Sungha Kim, Young-Eun Kim, So Young Jung, Bo-Young Kim, Jeong In Kang, Jun-Hwan Lee, Dong-Hyo Lee

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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.

Mi Ju SonKorea Institute of Oriental Medicine Korean Medicine Life Science, University of Science & Technology, Daejeon Department of Ophthalmology & Otolaryngology & Dermatology, Woo-Suk University Korean Medicine Hospital, Jeonju-si, Jeollabuk-do, Republic of Korea.
Ojin Kwon
Sungha Kim
Young-Eun Kim
So Young Jung
Bo-Young Kim
Jeong In Kang
Jun-Hwan Lee
Dong-Hyo Lee

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA herbal formula, Galgeun-tang-ga-cheongung-sinyi (GGTCS), is traditionally used for the treatment of rhinosinusitis in East Asian countries. However, there is a dearth of clinical evidence supporting the effects of this medication. Here, we describe the protocol for a randomized controlled study designed to investigate the efficacy and safety of GGTCS for the treatment of chronic rhinosinusitis (CRS). METHODS AND ANALYSIS: To investigate the clinical efficacy and safety of GGTCS for the treatment of CRS, a randomized, double-blind, placebo-controlled, parallel group, clinical trial has been designed. A total of 58 participants with CRS will be recruited and randomly allocated to a GGTCS or placebo group in a 1:1 ratio. The participants will be administered GGTCS or placebo granules 3 times a day for 8 weeks. Data will be collected from the participants at baseline and at 1, 2, 4, and 8 weeks after random allocation. The primary outcome measure will be the mean change in the Sino-Nasal Outcome Test-22 score from baseline to 8 weeks. The secondary outcomes will include the Total Nasal Symptom Score, EuroQoL 5 Dimensions 5 Levels score, Nasal Endoscopy Index, Lund-Mackay score, and total serum immunoglobulin E level. DISCUSSION: The key elements for conducting a high-quality randomized clinical trial have been addressed in this protocol. In summary, the findings of this study are expected to provide a base for large-scale randomized controlled trials to confirm the safety and efficacy of GGTCS for the treatment of CRS and may consequently serve to improve future treatment strategies for this condition.

trial registrationThis study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0002835).

Indexed as

AdultAsia, EasternChronic DiseaseClinical ProtocolsDrugs, Chinese HerbalEndoscopyFemaleHumansImmunoglobulin EMaleMiddle AgedRhinitisSinusitisTreatment OutcomeDrugs, Chinese Herbalgalgeun-tangImmunoglobulin E

Identifiers

PMID29924041
PMCPMC6023643

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Registered trials

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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.