Clinical trial NCT04153552: 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
Overall status: COMPLETED
Phase: NA
Conditions: Indigestion
Heartburn
Keywords: Natural
Supplement
Lead sponsor: Hawthorne Effect Inc.
Sponsor class: OTHER
Collaborators: name: HLNatural, Inc.
First posted: 2019-11-06
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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.)

Primary outcomes:
measure: Outcomes of the severity and reduction of indigestion while consuming HLNatural Supplement.
timeFrame: The improvements in symptoms will be evaluated from baseline.
Secondary outcomes:
measure: Outcomes of time to relief or to alternative treatment while taking HLNatural Supplement
timeFrame: 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.
measure: Outcomes of all adverse events while consuming HLNatural Supplement
timeFrame: All adverse events will be captured throughout the trial which will be up to 60 days or 3 episodes of indigestion.
measure: Outcome of subjects natural behavior during the clinical trial
timeFrame: The time point will be evaluated from baseline to thoughout the trial up 60 days or 3 episodes of indigestion.
Other outcomes:
Locations:
city: New York
country: United States
facility: HLNatural, Inc.
state: New York
Study officials:
affiliation: Hawthorne Effect Inc.
name: Soyona Rafatjah, MD
role: PRINCIPAL_INVESTIGATOR
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