Evidence map›Paper›PMID 24274317›Full record

Trial reportBMC complementary and alternative medicine2013

The efficacy and safety of a proposed herbal moisturising cream for dry skin and itch relief: a randomised, double-blind, placebo-controlled trial--study protocol.

Dong-Hyo Lee, Eun-Sung Seo, Jin-Tae Hong, Gang-Tai Lee, Young-Kyoung You, Kun-Kook Lee, Ga-Won Jo, Nam-Kwen Kim

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary and alternative medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Observational
  4. Article
  5. Review
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

8 authors.

Dong-Hyo LeeOpthalmology Otolaryngology & Dermatology, Wonkwang University Sanbon Oriental Medical Centre, Gunpo, South Korea. drkim@wonkwang.ac.kr.
Eun-Sung Seo
Jin-Tae Hong
Gang-Tai Lee
Young-Kyoung You
Kun-Kook Lee
Ga-Won Jo
Nam-Kwen Kim

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMoisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics. METHODS/DESIGNS: This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs. DISCUSSION: This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ health-related quality of life questionnaires to assess changes in the quality of life. The results of this study will be used to present the evidence needed to request advertising/display allowances, in compliance with the recently amended Cosmetics Act for advertisement in Korea.

trial registrationCurrent Controlled Trials ISRCTN46216631.

Indexed as

AdultAgedAnalysis of VarianceArctiumDouble-Blind MethodFemaleHumansMaleMiddle AgedPlant ExtractsPruritusSkin CreamSkin DiseasesSurveys and QuestionnairesTreatment OutcomePlant Extracts

Identifiers

PMID24274317
PMCPMC4222493

What OpenQuestion holds

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LicenceCC BY
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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.