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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Description: Powdered extract obtained from Ginger rhizomes. Botanical name: Zingiber officinale Roscoe Plant part used: Dried rhyzome Extraction solvent: CO2 Extract Ratio 45-60 / 1 100mg of extract are equivalent to an average of 4400 mg of dry ginger rhizomes Composition: Natural extract, Calcium Hydroxide, Polysorbate 80, De-oiled soya lecithin, Calcium silicate
200 mg/d maltodextrin
Atlantia CRO, Heron House
Blackpool, Munster, Ireland
Intensity of functional dyspepsia symptom score over 4-weeks as measured by subject rating score at week-4
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
Time frame: 4-weeks
Intensity of functional dyspepsia symptoms over 2-weeks as measured by subject rating score
Overall score indicates the intensity of functional dyspepsia as defined by Subject's rating after two weeks of intervention with Gingest (100mg and 200mgs) versus placebo. 0: Not improved or worsened 1. Slightly improved 2. Markedly improved 3. Completely improved
Time frame: 2-weeks
Severity of dyspeptic symptoms as measured by subject severity score measured at week-4.
Overall severity of specific suite of dyspeptic symptoms (including epigastric fullness, bloating, early satiety, nausea, vomiting epigastric pain) Absence of symptoms =0 Mild Symptoms = 1 Moderate Symptoms = 2 Severe symptoms = 3
Time frame: 4-weeks
Participant Global Assessment as measured by Participant Global Assessment Score at week-4
Participant Global Assessment Short Form 36 assesses the overall general mental and physical health. Answers are combined to produce the following. Physical function score= a higher score means better health Role limitation due to physical health Score: a lower score means better health Role limitations due to emotional problems Score: a lower score means better health Energy/ fatigue Score: a lower score means better health Emotional well-being Score: a higher score means better health Social Functioning Score: a higher score means better health Pain Score: a lower score means better health General health Score: a higher score means better health
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4 weeks
Leeds Dyspepsia Questionnaire as measured by total score at week-4
Overall score is calculated from subject rating for frequency and severity responses for each symptom of dyspepsia. a summed total score of the frequency and severity responses for each symptom( Indigestion, heartburn, regurgitation, nausea combined) range: 0-32). 0= least severe.32= most severe each symptom = indigestion, regurgitation, heartburn and nausea a summed score of the frequency responses for each symptom (range: 0-16); a summed score of the severity responses for each symptom (range: 0-16); a categorized score of the single most frequent symptom (range: 0-4) and a categorized score of the single most severe symptom (range: 0-4).
Time frame: 4 weeks
Profile of Mood States Questionnaire (POMS) as measured by score at week-4.
Overall score assess changes in mood Not at all= 0 little = 1 Moderately = 2 Quite a lot = 3 Extremely = 4 Answers are combined. Higher the score for negative feelings i.e. tense the worse the mood. Higher the score for positive feelings i.e. Energetic the better the mood.
Time frame: 4 weeks
Beck's Depression Inventory as measured by score at week-4.
Overall score indicates severity of depressive symptoms 1-10 = These ups and downs are considered normal 11-16\_\_ Mild mood disturbance 17-20\_\_Borderline clinical depression 21-30\_Moderate depression 31-40\_Severe depression over 40\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Extreme depression
Time frame: 4 weeks
Cortisol awakening response (nmol/L) at week-4.
Measures salivary cortisol (nmol/L)
Time frame: 4 weeks
Reduction in medication to manage number of episodes requiring medication for dyspeptic symptoms as measured at week-4
Number of times medication is taken to manage dyspeptic symptoms
Time frame: 4 weeks
Safety as assessed by adverse events and serious adverse events ongoing throughout the trial
Number of adverse events and serious adverse events
Time frame: 4 weeks