Clinical trial: Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn (NCT04153552)

Eligibility criteria:
Inclusion Criteria:

          -  Adult candidates who are in overall good health but who suffer from the symptoms of
             indigestion.

          -  Participants will be deemed to be in good health if they do not report any of the
             existing medical conditions asked about in the screening questionnaire.

        Exclusion Criteria:

          -  Age <18 years old.

          -  Unwilling to take test product for their symptoms.

          -  Are not able to swallow pills.

          -  Allergy to any of the following: Licorice, Artichoke Leaf, Marshmallow Root, Ginger,
             Chamomile, Cellulose Capsule, Rice Hull Concentrate, Carrageenan.

          -  Has any of the following medical conditions:

               -  Has had an ulcer

               -  Has been diagnosed with a digestive disorder

               -  Diagnosed with gastroesophageal reflux disorder

               -  Participants with diagnosed with irritable bowel syndrome

               -  Participants with active HP infection or with gastric or duodenal ulcer

          -  Participants who have been prescribed any medication by their physician for any GI
             disorder or medication that can affect the GI system.

          -  Participants with previous diagnosis of cancer or with previous surgery of the upper
             gastrointestinal tract or of the biliopancreatic system (except for cholecystectomy)

          -  Pregnant women or breastfeeding.

          -  Alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion

          -  Participant who scores a 0, 3, or 4 on the Dyspepsia Symptom Severity Index

          -  Participants who are currently using anticoagulation medications daily. (Aspirin,
             Coumadin, Heparin etc.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Entailment