An interventional study of HLNatural, Inc. Upset Stomach Relief in Indigestion and Heartburn, sponsored by Hawthorne Effect Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by Hawthorne Effect Inc. · Not applicable, Interventional, and Other
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.
The purpose of the present study is to evaluate 1) the impact of the test product on symptoms of occasional indigestion and heartburn in 200 adult participants who suffer from occasional indigestion and heartburn and 2) the subjective experience of these participants related to general health, indigestion and heartburn symptoms, and personal experience with the test product.
While dietary and lifestyle changes can ease the symptoms of indigestion and heartburn, HLNatural, Inc. created the test product to reduce occasional indigestion and heartburn. The test product is a plant-based remedy formulated with ingredients that have demonstrated efficacy reducing symptoms associated with occasional indigestion and heartburn.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's enrollment of 161 is above the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Hawthorne Effect Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Has any of the following medical conditions:
Subjects who meet the inclusion/exclusion criteria for the trial will be invited to participate in the trial. Subjects will be asked to sign a consent and complete screening survey. At the onset on an episode of the subject will start a symptom diary and completed and rate the symptoms using a 4-point Likert scale for each symptom. The participant will take 2 capsules per indigestion and heartburn episode. With a max of 6 capsules per day. • After taking the test product, the participant will complete a 4-point Likert scale assessment for each symptom at 15 minutes, 30 minutes, and 1 hour after taking the test product.
Dietary Supplement: HLNatural, Inc. Upset Stomach Relief
Supplement to take with mild to moderate indigestion. The degree of your indigestion pre and post will be recorded
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.
Time frame: The improvements in symptoms will be evaluated from baseline.
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.
Time frame: 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.
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.
Time frame: All adverse events will be captured throughout the trial which will be up to 60 days or 3 episodes of indigestion.
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.
Time frame: The time point will be evaluated from baseline to thoughout the trial up 60 days or 3 episodes of indigestion.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Once the trial is completed and the data has been analyzed then a decision will be made on how to use the data.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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