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Completed

NCT Number: NCT04153552

Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

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.

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Key information

Conditions

Indigestion Dyspepsia Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HLNatural, Inc.

New York, 10017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

HLNatural, Inc. Upset Stomach Relief

Dietary Supplement

Supplement to take with mild to moderate indigestion. The degree of your indigestion pre and post will be recorded

Primary outcomes

  1. Outcomes of the severity and reduction of indigestion while consuming HLNatural Supplement.

    Time frame: The improvements in symptoms will be evaluated from baseline.

    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.

Secondary outcomes

  1. Outcomes of time to relief or to alternative treatment while taking HLNatural Supplement

    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.

    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.

  2. Outcomes of all adverse events while consuming HLNatural Supplement

    Time frame: All adverse events will be captured throughout the trial which will be up to 60 days or 3 episodes of indigestion.

    Participants will be asked to report any adverse events that the subject experiences throughout the study.

  3. Outcome of subjects natural behavior during the clinical trial

    Time frame: The time point will be evaluated from baseline to thoughout the trial up 60 days or 3 episodes of indigestion.

    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.

Sponsors and collaborators

Lead sponsor

Hawthorne Effect Inc.

Other

Collaborators

  • HLNatural, Inc.

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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