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Published in: Trials 1/2020

01-12-2020 | Ulcerative Colitis | Study protocol

Ginger in patients with active ulcerative colitis: a study protocol for a randomized controlled trial

Authors: Forough Shayesteh, Fatemeh Haidari, Ali Akbar Shayesteh, Javad Mohammadi-Asl, Kambiz Ahmadi-Angali

Published in: Trials | Issue 1/2020

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Abstract

Background

As a lifetime disorder, ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects quality of life and also demands long-term interventions. In spite of considerable side effects and sometimes restricted uses, efficient medications are available for UC treatment. Some in vitro and in vivo examinations have correspondingly introduced ginger and its active components with antioxidant, anti-inflammatory, and anti-ulcerative properties. Therefore, this trial aims to evaluate the effect of ginger supplementation on patients with active UC.

Methods

This study will be a 12-week, double-blind, parallel-group, randomized, controlled trial (RCT) in which 44 patients will be allocated to ginger and placebo groups receiving basic routine treatments plus ginger or placebo capsules, respectively. The primary outcomes are inflammatory markers (TNF-α and hs-CRP) and total antioxidant capacity.

Discussion

The findings of this trial will provide evidence on the effect of ginger on patients with active UC.

Trial registration

Iranian Registry of Clinical Trials, IRCT201901290425​52N1. Registered on 21 June 2019.
Appendix
Available only for authorised users
Literature
1.
Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, Burisch J, Gecse KB, Hart AL, Hindryckx P, Langner C. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 1: Definitions, diagnosis, extra-intestinal manifestations, pregnancy, cancer surveillance, surgery, and ileo-anal pouch disorders. J Crohns Colitis. 2017;11(6):649–70.CrossRef
2.
Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JC, Chan FK, Sung JJ. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017;390(10114):2769–78.CrossRef
3.
Malekzadeh MM, Vahedi H, Gohari K, Mehdipour P, Sepanlou SG, Ebrahimi Daryani N, Zali MR, Mansour-Ghanaei F, Safaripour A, Aghazadeh R, Vossoughinia H. Emerging epidemic of inflammatory bowel disease in a middle income country: a nation-wide study from Iran. Arch Iran Med. 2016;19:1–4.
4.
Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007;448(7152):427–34.CrossRef
5.
Johnston DG, Williams MA, Thaiss CA, Cabrera-Rubio R, Raverdeau M, McEntee C, Cotter PD, Elinav E, O’Neill LA, Corr SC. Loss of MicroRNA-21 influences the gut microbiota, causing reduced susceptibility in a murine model of colitis. J Crohns Colitis. 2018;1:14.
6.
Shi C, Liang Y, Yang J, Xia Y, Chen H, Han H, Yang Y, Wu W, Gao R, Qin H. MicroRNA-21 knockout improve the survival rate in DSS induced fatal colitis through protecting against inflammation and tissue injury. PLoS One. 2013;8(6):e66814.CrossRef
7.
Yang Y, Ma Y, Shi C, Chen H, Zhang H, Chen N, Zhang P, Wang F, Yang J, Yang J, Zhu Q. Overexpression of miR-21 in patients with ulcerative colitis impairs intestinal epithelial barrier function through targeting the Rho GTPase RhoB. Biochem Biophys Res Commun. 2013;434(4):746–52.CrossRef
8.
Sawant DV, Wu H, Kaplan MH, Dent AL. The Bcl6 target gene microRNA-21 promotes Th2 differentiation by a T cell intrinsic pathway. Mol Immunol. 2013;54(3):435–42.CrossRef
9.
Murugaiyan G, da Cunha AP, Ajay AK, Joller N, Garo LP, Kumaradevan S, Yosef N, Vaidya VS, Weiner HL. MicroRNA-21 promotes Th17 differentiation and mediates experimental autoimmune encephalomyelitis. J Clin Invest. 2015;125(3):1069–80.CrossRef
10.
Siegel. CA. Review article: explaining risks of inflammatory bowel disease therapy to patients. Aliment Pharmacol Ther. 2011;33(1):23–32.CrossRef
11.
Grzanna R, Lindmark L, Frondoza. CG. Ginger—an herbal medicinal product with broad anti-inflammatory actions. J Med Food. 2005;8(2)):125–32.CrossRef
12.
13.
Mozaffari-Khosravi H, Naderi Z, Dehghan A, Nadjarzadeh A, Fallah Huseini H. Effect of ginger supplementation on proinflammatory cytokines in older patients with osteoarthritis: outcomes of a randomized controlled clinical trial. J Nutr Gerontol Geriatr. 2016;35(3):209–18.CrossRef
14.
Naderi Z, Mozaffari-Khosravi H, Dehghan A, Nadjarzadeh A, Huseini HF. Effect of ginger powder supplementation on nitric oxide and C-reactive protein in elderly knee osteoarthritis patients: a 12-week double-blind randomized placebo-controlled clinical trial. J Tradit Complement Med. 2016;6(3):199–203.CrossRef
15.
Aryaeian N, Shahram F, Mahmoudi M, Tavakoli H, Yousefi B, Arablou T, Karegar SJ. The effect of ginger supplementation on some immunity and inflammation intermediate genes expression in patients with active rheumatoid arthritis. Gene. 2019;698:179–85.CrossRef
16.
Allah ES, Makboul R, Mohamed AO. Role of serotonin and nuclear factor-kappa B in the ameliorative effect of ginger on acetic acid-induced colitis. Pathophysiology. 2016;23(1):35–42.CrossRef
17.
Ajayi BO, Adedara IA, Farombi EO. Pharmacological activity of 6-gingerol in dextran sulphate sodium-induced ulcerative colitis in BALB/c mice. Phytother Res. 2015;29(4):566–72.CrossRef
18.
Dileep R, Usharani M, Gopu B, Reddy AG, Kumar MV, Kumar CS, Madhuri D. Ameliorative effect of ginger extract in acetic acid induced ulcerative colitis in rats. Asian J Anim Vet Adv. 2016;11:130–6.CrossRef
19.
Shin JW, Seol IC, Son CG. Interpretation of animal dose and human equivalent dose for drug development. J Korean Orient Med. 2010;31(3):1–7.
20.
Mozaffari-Khosravi H, Talaei B, Jalali BA, Najarzadeh A, Mozayan MR. The effect of ginger powder supplementation on insulin resistance and glycemic indices in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Complement Ther Med. 2014;22(1):9–16.CrossRef
Metadata
Title
Ginger in patients with active ulcerative colitis: a study protocol for a randomized controlled trial
Authors
Forough Shayesteh
Fatemeh Haidari
Ali Akbar Shayesteh
Javad Mohammadi-Asl
Kambiz Ahmadi-Angali
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4193-7

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