Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

Hawthorne Effect

Status: Completed

Conditions: Heartburn; Indigestion

Treatments: Dietary Supplement: HLNatural, Inc. Upset Stomach Relief

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04153552

Pro00037630

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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161 participants in 1 patient group

Study Participants who Suffer from Heartburn or indigestion

Other group

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.

Treatment:

Dietary Supplement: HLNatural, Inc. Upset Stomach Relief