DyspepsiaNCT03548363
Effect of Gingest on Symptoms of Dyspepsia
A study testing Gingest powdered extract obtained from Ginger rhizomes in people with Dyspepsia and Epigastric Fullness, run by Atlantia Food Clinical Trials at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia, Epigastric Fullness, Bloating
- What is being tested?
- Gingest powdered extract obtained from Ginger rhizomes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- 13 Mar 2018to 2 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Gingest on Symptoms of Dyspepsia
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.
Read the detailed description
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).
- Conditions
- Dyspepsia, Epigastric Fullness, Bloating, Epigastric Pain
- Being tested
- Gingest powdered extract obtained from Ginger rhizomes, Placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingest powdered extract obtained from Ginger rhizomesDietary supplement
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
PlaceboDietary supplement
200 mg/d maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Gingest High | Active comparator | 200 mg/d Gingest (powdered extract obtained from Ginger rhizomes) for 4-weeks Receives: Dietary Supplement: Gingest powdered extract obtained from Ginger rhizomes |
| Gingest low | Active comparator | 100 mg/d Gingest (powdered extract obtained from Ginger rhizomes) + 100 mg maltodextrin for 4-weeks Receives: Dietary Supplement: Gingest powdered extract obtained from Ginger rhizomes |
| Placebo | Placebo comparator | 200 mg/d maltodextrin for 4-weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Slightly improved
- Markedly improved
- Completely improved
Measured: 4-weeks
Secondary outcomes (9)
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
- Slightly improved
- Markedly improved
- Completely improved
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 4 weeks
Cortisol awakening response (nmol/L) at week-4.
Measures salivary cortisol (nmol/L)
Measured: 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
Measured: 4 weeks
Safety as assessed by adverse events and serious adverse events ongoing throughout the trial
Number of adverse events and serious adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start13 Mar 2018
- Primary completion2 Jan 2019
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, 4-week parallel intervention in subjects with mild to moderate Dyspepsia (as defined by the Leeds Dyspepsia Questionnaire) in 3-treatment arms: 1.) 100 mg/d Gingest; 2.) 200 mg/d Gingest; 3.) Placebo (maltodextrin)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantia Food Clinical Trials
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Givaudan France Naturals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548363
- Sponsor's protocol ID
- AFCRO 085
- Status last verified
- Jan 2019
- First submitted
- 11 Apr 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will remain proprietary and will only be shared with Naturex (commercial partner) and contract statisticians.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Gingest on Symptoms of Dyspepsia
- ClinicalTrials.gov ID
- NCT03548363
- Acronym / sponsor ID
- AFCRO 085
- Conditions
- Dyspepsia, Epigastric Fullness, Bloating, Epigastric Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Atlantia Food Clinical TrialsIndustry (pharma, biotech, devices)
- Collaborators
- Givaudan France Naturals
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double-blind, placebo-controlled, 4-week parallel intervention in subjects with mild to moderate Dyspepsia (as defined by the Leeds Dyspepsia Questionnaire) in 3-treatment arms: 1.) 100 mg/d Gingest; 2.) 200 mg/d Gingest; 3.) Placebo (maltodextrin)
| Arm | Type | Receives |
|---|---|---|
| Gingest High | Active comparator | Dietary Supplement: Gingest powdered extract obtained from Ginger rhizomes200 mg/d Gingest (powdered extract obtained from Ginger rhizomes) for 4-weeks |
| Gingest low | Active comparator | Dietary Supplement: Gingest powdered extract obtained from Ginger rhizomes100 mg/d Gingest (powdered extract obtained from Ginger rhizomes) + 100 mg maltodextrin for 4-weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo200 mg/d maltodextrin for 4-weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingest powdered extract obtained from Ginger rhizomesDescription: 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 | Dietary supplement | Gingest High, Gingest low |
| Placebo200 mg/d maltodextrin | Dietary supplement | Placebo |
Primary outcome
Intensity of functional dyspepsia symptom score over 4-weeks as measured by subject rating score at week-4
Time frame: 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
9 secondary outcomes
Intensity of functional dyspepsia symptoms over 2-weeks as measured by subject rating score
Time frame: 2-weeks
Severity of dyspeptic symptoms as measured by subject severity score measured at week-4.
Time frame: 4-weeks
Participant Global Assessment as measured by Participant Global Assessment Score at week-4
Time frame: 4 weeks
Leeds Dyspepsia Questionnaire as measured by total score at week-4
Time frame: 4 weeks
Profile of Mood States Questionnaire (POMS) as measured by score at week-4.
Time frame: 4 weeks
Beck's Depression Inventory as measured by score at week-4.
Time frame: 4 weeks
Cortisol awakening response (nmol/L) at week-4.
Time frame: 4 weeks
Reduction in medication to manage number of episodes requiring medication for dyspeptic symptoms as measured at week-4
Time frame: 4 weeks
Safety as assessed by adverse events and serious adverse events ongoing throughout the trial
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No. All data will remain proprietary and will only be shared with Naturex (commercial partner) and contract statisticians.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingest powdered extract obtained from Ginger rhizomes in people with Dyspepsia and Epigastric Fullness, run by Atlantia Food Clinical Trials at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of functional dyspepsia symptom score over 4-weeks as measured by subject rating score at week-4 (time frame: 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.