The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Body Fat Content Analysis
研究概览
简要总结
The goal of this clinical trial is to assess ginger's effect on patients with functional dyspepsia.
The main question[s] it aims to answer are:
- Does ginger intake improve functional dyspepsia symptoms?
- Does ginger intake decrease the body fat content among patients with functional dyspepsia? Dyspepsia patients will be asked to take 540 mg of ginger capsule twice a day. Researchers will assess if there is an improvement in the symptoms of the disease and the fat content. [ to see if gingers effect.
详细描述
Brief description of the study:
Currently, the options for managing functional dyspepsia are limited and far from ideal. Few conducted studies showed that ginger consumption has a therapeutic and preventive effect on functional dyspepsia however, the results were not conclusive. Therefore, this study will try to investigate the effect of ginger supplementation on functional dyspepsia symptoms and body fat content among patients with Functional dyspepsia.
Volunteers with functional dyspepsia 62 participants will be will take as tablets containing 540mg ginger capsule twice a day for four weeks with follow-up. Functional dyspepsia symptoms will be asked before and after the intervention using a questionnaire based on the symptoms of Rome IV criteria, including gastric fullness, early satiety, nausea, vomiting, belching, epigastric pain and heartburn which will be graded through visual analog scales (0- 10 scores) and measured for the body contents.
Method and Materials
Sample size, sample selection:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from Functional dyspepsia symptoms
排除标准
- •Patients with relevant gastroesophageal reflux symptoms (retrosternal pain, burning, or regurgitation) as well as patients with clear evidence of irritable bowel syndrome will not be included. Patients under treatment with pharmacological substances that could influence the gastrointestinal system, such as prokinetics, ursodeoxycholic acid (UDCA), nonsteroidal anti-inflammatory drugs (NSAIDs), cholagogues, protonpump inhibitors, and H2 blockers, will be asked to interrupt this treatment for one month before starting the study treatment.
- •Moreover, patients with a previous diagnosis of cancer or with previous surgery of the upper gastrointestinal tract or of the biliopancreatic system (except for cholecystectomy) and patients with active HP infection or with gastric or duodenal ulcer, as well as pregnant women, will be excluded.
结局指标
主要结局
Body Fat Content Analysis
时间窗: Four weeks
Changes in body fat content, which will be assessed before and after four weeks of ginger supplementation using the In-Body 270, a non-invasive device that measures body weight, skeletal muscle mass, body fat, and other health parameters at five body parts using two different frequencies. This measure aims to evaluate the impact of Functional Dyspepsia and ginger supplementation on body composition, which could be relevant due to potential associations between functional dyspepsia and alterations in body fat distribution.
Functional Dyspepsia Symptom Severity
时间窗: four weeks
This study will evaluate and measure the expected improvements in functional dyspepsia symptoms. It will be assessed by the Nepean Dyspepsia Index (NDI) questionnaire, among 62 patients with functional dyspepsia treated with ginger supplementation compared to the baseline, by the end of the four-week intervention. This measure focuses on the reduction in symptoms such as pain, discomfort, bloating, and early satiety. Each item on the Nepean Dyspepsia Index questionnaire is usually scored on a Likert scale, with higher scores representing more severe symptoms or greater impairment. I.e. Higher scores on the Nepean Dyspepsia Index indicate more severe dyspeptic symptoms and a greater impact on quality of life. Lower scores indicate milder symptoms and less impairment in quality of life. Therefore, a reduction in Nepean Dyspepsia Index scores in response to ginger supplementation indicates an improvement in symptoms and quality of life for individuals with dyspepsia.
次要结局
- Improvement in Quality of Life(Four weeks)
研究者
Lemlem Gebremariam Aregawi
Principal Investigator
University of Debrecen