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

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.

Ginger and its constituents: Role in treatment of inflammatory bowel disease

“…It was shown that 6G significantly ameliorated inflammatory and oxidative process 48 . In IBD models, it was indicated that 6G suppressed ROS and NO expression due to NF‐kB restraint 16,37 . 6G also diminished NO, COX‐2, PGE2, TNF‐α, IL‐2, IL‐4, IL‐5, IL‐12, IL‐17, and IL‐1β.…”

“…Ginger exhibited successful therapeutic effects when administered via different routes in experimental animal models, that is, by oral gavage 36 or intraperitoneal 37 administration. In addition, orally prescribed ginger capsules in human clinical trials showed that daily treatment with ginger powder proved beneficial for UC management 16,41 . Nanomedicine drug delivery systems are recent developments of new selectively polymeric carriers and novel synthetic approaches for enhancing beneficial physicochemical properties and penetration of medicines in IBD.…”

“…On the other hand, ginger at a dose of 2000 mg/day, did not impact the serum total antioxidant capacity (TAC) after 12 weeks of intervention 41 . Meanwhile, alteration in the serum levels of TAC in patients with active UC is under investigation in an ongoing clinical trial with 3000 mg/day of ginger for 12 weeks 16 …”

“…Oral administration of GE for 5 days significantly reduced the TNF‐α, MPO, and prostaglandin E 2 (PGE 2 ) levels 40 . An ongoing double‐blind, randomized control trial (RCT) is exploring the effect of ginger in suppression of inflammatory markers, such as TNF‐α, high‐sensitivity C‐reactive protein (hs‐CRP), and the expression of microRNA‐21 (miR‐21) in patients suffering from moderate to severe active UC 16 …”

Natural compounds as safe therapeutic options for ulcerative colitis

“…Another double blind, randomized, controlled study indicating the efficacy of ginger capsule in UC patients was performed. The down-regulation of inflammatory mediators and high sensitivity of C-reactive protein (hs-CRP) showed protective effect in treatment of UC and can be given up to 3 g/kg (Shayesteh et al 2020 ).…”