Heartburn Clinical Trial
Official title:
Evaluation of the Impact of the HLNatural, Inc. Upset Stomach Relief Product on the Reduction of Symptoms in Adults Who Suffer From Mild to Moderate Indigestion and Heartburn
Verified date | November 2021 |
Source | Hawthorne Effect Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary hypothesis of the present study is that supplementation with the Upset Stomach Relief test product will reduce the severity of the symptoms of occasional indigestion and heartburn.
Status | Completed |
Enrollment | 161 |
Est. completion date | August 18, 2020 |
Est. primary completion date | August 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
United States | HLNatural, Inc. | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hawthorne Effect Inc. | HLNatural, Inc. |
United States,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Outcomes of the severity and reduction of indigestion while consuming HLNatural Supplement. | Participants will be asked to rate each symptom (bloating, early fullness during a meal, pain or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of your chest, nausea, vomiting, and burping) on a 4-point scale at 4 time points. • At the onset of the indigestion and heartburn episode, the participant will start a Symptom Diary and complete a 4-point Likert scale for each of the symptoms they are experiencing. | The improvements in symptoms will be evaluated from baseline. | |
Secondary | Outcomes of time to relief or to alternative treatment while taking HLNatural Supplement | The participant is allowed to take alternative medications or supplements AFTER 1 hour from taking the test product. • If the participant takes any other medication outside of the test product, the participant will record this on the symptom diary. | The subject will write down symptoms in a diary and start of symptoms and again at 60 mins. The subject ill complete 4-point Likert Scale at start of event, 15 minutes, 30 minutes and 60 minutes after start of event. | |
Secondary | Outcomes of all adverse events while consuming HLNatural Supplement | Participants will be asked to report any adverse events that the subject experiences throughout the study. | All adverse events will be captured throughout the trial which will be up to 60 days or 3 episodes of indigestion. | |
Secondary | Outcome of subjects natural behavior during the clinical trial | At the start of the study participants will be asked to complete screening, baseline and demographic survey. At the completed of the study an exit study will be completed. This information along with what appears in the literature will help the investigators to better understand expected normal behavior of the participant. | The time point will be evaluated from baseline to thoughout the trial up 60 days or 3 episodes of indigestion. |
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