A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Gingest on Symptoms of Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Intensity of functional dyspepsia symptom score over 4-weeks as measured by subject rating score at week-4
研究概览
简要总结
This is a randomised, double-blind, placebo controlled study on the effect of Gingest (ginger root extract) on symptoms of dyspepsia in 150 participants with mild to moderate dyspepsia.
详细描述
Functional dyspepsia (FD) is a chronic disorder of sensation and movement (peristalsis) in the upper digestive tract. A diagnosis of functional dyspepsia is determined when there is no evidence of structural disease and there have been at least three months of one or more of the following (with onset at least six months earlier). Ginger (Zingiber officinale) is traditionally used to treat a number of medical conditions, including those affecting the digestive tract, such as dyspepsia, flatulence, nausea and abdominal pain. Recent human clinical studies have found beneficial effects of ginger extract in patients with dyspepsia and gastric emptying in healthy populations.
The aim of the present study is therefore to investigate if two different doses of Gingest (100mg and 200 mg) reduces intensity of functional dyspepsia (based on a symptom severity questionnaire) compared to placebo (maltodextrin) in 150 subjects with mild to moderate dyspepsia (as determined through the Leeds Dyspepsia Questionnaire).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Both the investigators with any involvement in the study or data analysis prior to database locking and subjects are blinded to what treatment they receive.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy free-living men and women,
- •Be aged 30 to 55 years (inclusive),
- •Be willing to provide informed consent,
- •Subject has upper abdominal pain or discomfort that is an unpleasant sensation, characterized by one or more of the following symptoms: early satiety, postprandial fullness, bloating, and nausea for at least 3 months during last year, without an identifiable underlying structural or biochemical motivation.
- •Leeds Dyspepsia Questionnaire score 8 to 24 (mild-moderate)
- •Beck's Depression Inventory score between 4 and 15
排除标准
- •Pregnancy/lactation
- •Subjects with relevant gastroesophageal reflux symptoms (retrosternal pain, burning, or regurgitation.
- •Subjects with clear evidence of irritable bowel syndrome.
- •Subjects 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, were asked to interrupt this treatment for one month before starting the study treatment.
- •Subjects with previous diagnosis of cancer or with previous surgery of the upper gastro gastrointestinal endoscopy were performed in order to exclude the presence of structural or biochemical causes of dyspepsia.
- •Participants are asked to avoid all foods containing ginger within the 14 days prior to study product administration and throughout the study. A list of foods high in ginger will be provided to subjects as a guide and this list will be reviewed at each visit.
- •Subject with known allergy to components of the test product
- •Any medical condition deemed exclusionary by the Principal Investigator
- •Subject has a history of drug and / or alcohol abuse at the time of enrolment
- •Change of dietary habit within the preceding month
- •Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
- •Subject currently involved in any other clinical trial or having participated in a trial within the preceding 60 days,
- •Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements,
- •Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing)
- •Subject has a history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years,
- •Subject has a significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives,
研究组 & 干预措施
Gingest High
200 mg/d Gingest (powdered extract obtained from Ginger rhizomes) for 4-weeks
干预措施: Gingest powdered extract obtained from Ginger rhizomes (Dietary Supplement)
Gingest low
100 mg/d Gingest (powdered extract obtained from Ginger rhizomes) + 100 mg maltodextrin for 4-weeks
干预措施: Gingest powdered extract obtained from Ginger rhizomes (Dietary Supplement)
Placebo
200 mg/d maltodextrin for 4-weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Intensity of functional dyspepsia symptom score over 4-weeks as measured by subject rating score at week-4
时间窗: 4-weeks
Overall score indicates the intensity of functional dyspepsia as defined by Subject's rating after four weeks of intervention with Gingest (100mg and 200mgs) versus placebo. The lower the score, the higher the intensity of the dyspeptic symptoms. 0: Not improved or worsened 1. Slightly improved 2. Markedly improved 3. Completely improved
次要结局
- Severity of dyspeptic symptoms as measured by subject severity score measured at week-4.(4-weeks)
- Participant Global Assessment as measured by Participant Global Assessment Score at week-4(4 weeks)
- Leeds Dyspepsia Questionnaire as measured by total score at week-4(4 weeks)
- Intensity of functional dyspepsia symptoms over 2-weeks as measured by subject rating score(2-weeks)
- Profile of Mood States Questionnaire (POMS) as measured by score at week-4.(4 weeks)
- Beck's Depression Inventory as measured by score at week-4.(4 weeks)
- Cortisol awakening response (nmol/L) at week-4.(4 weeks)
- Reduction in medication to manage number of episodes requiring medication for dyspeptic symptoms as measured at week-4(4 weeks)
- Safety as assessed by adverse events and serious adverse events ongoing throughout the trial(4 weeks)