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Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

Primary Purpose

Indigestion, Heartburn

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HLNatural, Inc. Upset Stomach Relief

About this trial

This is an interventional other trial for Indigestion focused on measuring Natural, Supplement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

HLNatural, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Participants who Suffer from Heartburn or indigestion

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04153552

First Posted

September 13, 2019

Last Updated

November 5, 2021

Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04153552

Brief Title

Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 16, 2019 (Actual)

Primary Completion Date

August 18, 2020 (Actual)

Study Completion Date

August 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Indigestion, Heartburn

Keywords

Natural, Supplement

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The present study will be a single site, prospective, one arm observational study of minimal risk consisting of at least 200 participants who suffer from symptoms of occasional indigestion and heartburn. Participants will begin taking the capsules at the onset of indigestion and heartburn symptoms. Onset is defined as the point in time the participant takes the test product for relief of symptoms.

Masking

None (Open Label)

Allocation

N/A

Enrollment

161 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Participants who Suffer from Heartburn or indigestion

Arm Type

Other

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

HLNatural, Inc. Upset Stomach Relief

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

The improvements in symptoms will be evaluated from baseline.

Secondary Outcome Measure Information:

Title

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

Description

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.

Title

Outcomes of all adverse events while consuming HLNatural Supplement

Description

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.

Title

Outcome of subjects natural behavior during the clinical trial

Description

Time Frame

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

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soyona Rafatjah, MD

Organizational Affiliation

Hawthorne Effect Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

HLNatural, Inc.

City

New York

State/Province

New York

ZIP/Postal Code

10017

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

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Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

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