Aregawi Lemlem Gebremariam, Zoltan Csiki
Institute of Nutrition, Faculty of Medical and Health Sciences, University of Debrecen, Debrecen, Hungary.
Department of Public Health, College of Medicine and Health Sciences, Adigrat University, Adigrat, Ethiopia.
Curr Ther Res Clin Exp. 2025 Apr 14;102:100792. doi: 10.1016/j.curtheres.2025.100792. eCollection 2025.
Functional dyspepsia (FD) is a prevalent upper gastrointestinal disorder characterized by chronic or recurrent symptoms, including epigastric pain, bloating, and nausea. Ginger (), a natural dietary supplement traditionally used to relieve gastrointestinal discomfort, has limited evidence regarding its safety and tolerability in patients with FD.
To evaluate the safety, tolerability, and adverse effects of ginger supplementation in patients with FD.
This open-label clinical trial was conducted at the Internal Medicine Outpatient Department, University of Debrecen. This study was conducted in full compliance with the ethical principles outlined in the Declaration of Helsinki. The study protocol was reviewed and approved by the Ethics Committee of the University of Debrecen (registry reference number: DE RKEB/IKEB 5622-2020). All participants provided written informed consent prior to their inclusion in the study. Fifty patients with FD were initially enrolled, and 47 participants completed the study. Ginger supplementation was administered at a dose of 1080 mg/d in divided doses over 8 weeks. Adverse effects were assessed weekly through clinical evaluations and self-reports, and tolerability was rated by participants at the end of the trial.
The study included 47 patients with FD who completed the trial, with a mean (SD) age of 51.49 (14.64) years. Of the participants, 78.7% were females. Ginger supplementation was well tolerated, with mild and transient adverse effects reported, including bloating (14.9%), heartburn (12.8%), and diarrhea (10.6%). None of these adverse events necessitated discontinuation of the treatment. Tolerability was rated as good or excellent by 87.2% of participants, and no severe adverse events were observed.
Preliminary findings suggest ginger is well tolerated and may be a viable complementary dietary therapy, though further research is needed. ClinicalTrials.gov identifier: NCT06313814.
功能性消化不良（FD）是一种常见的上消化道疾病，其特征为慢性或复发性症状，包括上腹部疼痛、腹胀和恶心。生姜是一种传统上用于缓解胃肠道不适的天然膳食补充剂，但关于其在FD患者中的安全性和耐受性的证据有限。
评估生姜补充剂对FD患者的安全性、耐受性和不良反应。
这项开放标签的临床试验在德布勒森大学内科门诊进行。本研究完全符合《赫尔辛基宣言》中概述的伦理原则。研究方案经德布勒森大学伦理委员会审查并批准（注册参考编号：DE RKEB/IKEB 5622-2020）。所有参与者在纳入研究前均提供了书面知情同意书。最初招募了50名FD患者，47名参与者完成了研究。生姜补充剂以1080毫克/天的剂量分多次服用，持续8周。通过临床评估和自我报告每周评估不良反应，并在试验结束时由参与者对耐受性进行评分。
该研究纳入了47名完成试验的FD患者，平均（标准差）年龄为51.49（14.64）岁。参与者中，78.7%为女性。生姜补充剂耐受性良好，报告的不良反应轻微且短暂，包括腹胀（14.9%）、烧心（12.8%）和腹泻（10.6%）。这些不良事件均未导致治疗中断。87.2%的参与者将耐受性评为良好或优秀，未观察到严重不良事件。
初步研究结果表明，生姜耐受性良好，可能是一种可行的补充性饮食疗法，不过仍需进一步研究。ClinicalTrials.gov标识符：NCT063138
