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Effect of Gingest on Symptoms of Dyspepsia

Sponsored by Atlantia Food Clinical Trials

About this trial

Last updated 7 years ago

Study ID

AFCRO 085

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Yes

Accepting

18 to 55 Years
All Sexes

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

1. Healthy free-living men and women,

2. Be aged 30 to 55 years (inclusive),

3. Be willing to provide informed consent,

4. 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.

5. Leeds Dyspepsia Questionnaire score 8 to 24 (mild-moderate)

6. Beck's Depression Inventory score between 4 and 15

Exclusion Criteria

1. Pregnancy/lactation

2. Subjects with relevant gastroesophageal reflux symptoms (retrosternal pain, burning, or regurgitation.

3. Subjects with clear evidence of irritable bowel syndrome.

4. 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.

5. 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.

6. 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.

7. Subject with known allergy to components of the test product

8. Any medical condition deemed exclusionary by the Principal Investigator

9. Subject has a history of drug and / or alcohol abuse at the time of enrolment

10. Change of dietary habit within the preceding month

11. Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease

12. Subject currently involved in any other clinical trial or having participated in a trial within the preceding 60 days,

13. 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,

14. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing)

15. 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,

16. 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,