Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

November 5, 2021 updated by: Hawthorne Effect Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10017
        • HLNatural, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study Participants who Suffer from Heartburn or indigestion
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The improvements in symptoms will be evaluated from baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
The time point will be evaluated from baseline to thoughout the trial up 60 days or 3 episodes of indigestion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

Investigators

  • Principal Investigator: Soyona Rafatjah, MD, Hawthorne Effect Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2019

Primary Completion (Actual)

August 18, 2020

Study Completion (Actual)

August 18, 2020

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00037630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Once the trial is completed and the data has been analyzed then a decision will be made on how to use the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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