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Published in: BMC Complementary Medicine and Therapies 1/2016

Open Access 01-12-2015 | Study protocol

Inhibitory effects of Cheongsangbangpoong-tang on both inflammatory acne lesions and facial heat in patients with acne vulgaris: A randomized controlled trial protocol

Authors: Kyuseok Kim, Kwan-Il Kim, Junhee Lee

Published in: BMC Complementary Medicine and Therapies | Issue 1/2016

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Abstract

Background

Due to increasing interest from acne patients concerned about the side effects associated with conventional therapies, complementary and alternative medicine (CAM) has been suggested as a new therapeutic modality for acne vulgaris. Herbal medicine is one of these CAM treatments. Cheongsangbangpoong-tang (CBT) is a common herbal formula used in patients with acne vulgaris in the clinical practice of Korean Medicine (KM). However, despite the common use of CBT in clinical practice, the current level of evidence is insufficient to support an inhibitory effect of CBT on inflammatory acne lesions and facial heat. Therefore, this study was designed to assess the inhibitory effect of CBT on both inflammatory acne lesions and facial heat.

Methods/design

A randomized, double-blind, parallel-group, and placebo-controlled trial will be conducted. Fifty-six participants with acne vulgaris will be randomized into one of two groups: the CBT or placebo groups. After randomization, participants will be prescribed either CBT or placebo three times a day at a dose of 5 g after meals for 8 weeks. The following outcome measurements will be used in the examination of subjects: the mean percentage change and the count change of the inflammatory and non-inflammatory acne lesions, the temperature of facial points on digital infrared thermal imaging (DITI), serum cortisol, serum dehydroepiandrosterone-sulfate (DHEA-S), visual analogue scale (VAS), investigator global assessment (IGA), and severity score on the Korean Acne Grading System (KAGS) from baseline to the end of the trial.

Discussion

This trial will provide evidence regarding the inhibitory effect of CBT on inflammatory acne lesions and facial heat. The findings of this trial may have important implications for the more widespread use of CBT for the treatment of acne vulgaris.

Trial registration

The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0001468.
Literature
1.
go back to reference Das S, Reynolds RV. Recent advances in acne pathogenesis: implications for therapy. Am J Clin Dermatol. 2014;15(6):479–88.CrossRefPubMed Das S, Reynolds RV. Recent advances in acne pathogenesis: implications for therapy. Am J Clin Dermatol. 2014;15(6):479–88.CrossRefPubMed
2.
go back to reference Berle CA, Cobbin D, Smith N, Zaslawski C. A novel approach to evaluate Traditional Chinese Medicine treatment outcomes using pattern identification. J Altern Complement Med. 2010;16(4):357–67.CrossRefPubMed Berle CA, Cobbin D, Smith N, Zaslawski C. A novel approach to evaluate Traditional Chinese Medicine treatment outcomes using pattern identification. J Altern Complement Med. 2010;16(4):357–67.CrossRefPubMed
3.
go back to reference Jeong W, Hong E, Shin J, Kim Y, Nam H, Lee J, et al. A Study on the Major Symptoms by Each Pattern of Acne Vulgaris. J Korean Med Ophthalmol Otolaryngol Dermatol. 2014;27(4):76–86.CrossRef Jeong W, Hong E, Shin J, Kim Y, Nam H, Lee J, et al. A Study on the Major Symptoms by Each Pattern of Acne Vulgaris. J Korean Med Ophthalmol Otolaryngol Dermatol. 2014;27(4):76–86.CrossRef
4.
go back to reference Shin J, Jeong W, Moon Y, Nam H, Kim Y, Lee J, et al. An Expert Survey for Developing the Pattern Diagnosis Instrument of Acne. J Korean Med Ophthalmol Otolaryngol Dermatol. 2015;28(2):23–32.CrossRef Shin J, Jeong W, Moon Y, Nam H, Kim Y, Lee J, et al. An Expert Survey for Developing the Pattern Diagnosis Instrument of Acne. J Korean Med Ophthalmol Otolaryngol Dermatol. 2015;28(2):23–32.CrossRef
5.
go back to reference Chen HY, Lin YH, Hu S, Yang SH, Chen JL, Chen YC. Identifying chinese herbal medicine network for eczema: implications from a nationwide prescription database. Evid Based Complement Alternat Med. 2015;2015:347164.PubMedCentralPubMed Chen HY, Lin YH, Hu S, Yang SH, Chen JL, Chen YC. Identifying chinese herbal medicine network for eczema: implications from a nationwide prescription database. Evid Based Complement Alternat Med. 2015;2015:347164.PubMedCentralPubMed
6.
go back to reference Gong TX. Million disease rejuvenation – TCM (Chinese Edition), 1998. Beijing. Traditional Chinese Medicine Press, ISBN 9787800895906. Gong TX. Million disease rejuvenation – TCM (Chinese Edition), 1998. Beijing. Traditional Chinese Medicine Press, ISBN 9787800895906.
7.
go back to reference Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4, e5.PubMedCentralPubMed Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4, e5.PubMedCentralPubMed
8.
go back to reference Paithankar DY, Sakamoto FH, Farinelli WA, Kositratna G, Blomgren RD, Meyer TJ, et al. Acne Treatment Based on Selective Photothermolysis of Sebaceous Follicles with Topically Delivered Light-Absorbing Gold Microparticles. J Invest Dermatol. 2015;135(7):1727–34.PubMedCentralCrossRefPubMed Paithankar DY, Sakamoto FH, Farinelli WA, Kositratna G, Blomgren RD, Meyer TJ, et al. Acne Treatment Based on Selective Photothermolysis of Sebaceous Follicles with Topically Delivered Light-Absorbing Gold Microparticles. J Invest Dermatol. 2015;135(7):1727–34.PubMedCentralCrossRefPubMed
9.
go back to reference Arowojolu AO, Gallo MF, Lopez LM, Grimes DA. Combined oral contraceptive pills for treatment of acne. Cochrane Database Syst Rev. 2012;7:CD004425.PubMed Arowojolu AO, Gallo MF, Lopez LM, Grimes DA. Combined oral contraceptive pills for treatment of acne. Cochrane Database Syst Rev. 2012;7:CD004425.PubMed
10.
go back to reference Draft Guidence. Guidance for Industry. Acne Vulgaris: Developing. Drugs for Treatment. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research. 2005. Draft Guidence. Guidance for Industry. Acne Vulgaris: Developing. Drugs for Treatment. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research. 2005.
11.
go back to reference Kim KS, Kim YB. Anti-inflammatory effect of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: a randomized controlled pilot trial. J Altern Complement Med. 2012;18(5):501–8.CrossRefPubMed Kim KS, Kim YB. Anti-inflammatory effect of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: a randomized controlled pilot trial. J Altern Complement Med. 2012;18(5):501–8.CrossRefPubMed
12.
go back to reference Qi GD1, We DA, Chung LP, Fai CK. Placebos used in clinical trials for Chinese herbal medicine. Recent Pat Inflamm Allergy Drug Discov. 2008;2(2):123–7.CrossRefPubMed Qi GD1, We DA, Chung LP, Fai CK. Placebos used in clinical trials for Chinese herbal medicine. Recent Pat Inflamm Allergy Drug Discov. 2008;2(2):123–7.CrossRefPubMed
13.
go back to reference Fai CK, Qi GD, Wei DA, Chung LP. Placebo preparation for the proper clinical trial of herbal medicine--requirements, verification and quality control. Recent Pat Inflamm Allergy Drug Discov. 2011;5(2):169–74.CrossRefPubMed Fai CK, Qi GD, Wei DA, Chung LP. Placebo preparation for the proper clinical trial of herbal medicine--requirements, verification and quality control. Recent Pat Inflamm Allergy Drug Discov. 2011;5(2):169–74.CrossRefPubMed
14.
go back to reference Flower A, Witt C, Liu JP, Ulrich-Merzenich G, Yu H, Lewith G. Guidelines for randomised controlled trials investigating Chinese herbal medicine. J Ethnopharmacol. 2012;140(3):550–4.CrossRefPubMed Flower A, Witt C, Liu JP, Ulrich-Merzenich G, Yu H, Lewith G. Guidelines for randomised controlled trials investigating Chinese herbal medicine. J Ethnopharmacol. 2012;140(3):550–4.CrossRefPubMed
15.
go back to reference Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 2006;144(5):364–7.CrossRefPubMed Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 2006;144(5):364–7.CrossRefPubMed
Metadata
Title
Inhibitory effects of Cheongsangbangpoong-tang on both inflammatory acne lesions and facial heat in patients with acne vulgaris: A randomized controlled trial protocol
Authors
Kyuseok Kim
Kwan-Il Kim
Junhee Lee
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2016
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-016-1000-9

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