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| Name | Class |
|---|---|
| HLNatural, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants who Suffer from Heartburn or indigestion | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The improvements in symptoms will be evaluated from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
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:
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.)
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| Name | Affiliation | Role |
|---|---|---|
| Soyona Rafatjah, MD | Hawthorne Effect Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HLNatural, Inc. | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/ | ||
| Background | 2. Artichoke: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-842/artichoke | ||
| Background | 3. Chamomile Plant, Tea, and Oils: Health Benefits and Uses. (n.d.). Retrieved from https://www.webmd.com/diet/supplement-guide-chamomile#1 | ||
| Background | 5. Dyspepsia (Indigestion). (2011, March 01). Retrieved from https://www.aafp.org/afp/2011/0301/p554.html | ||
| Background | 6. Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Cham: Springer. | ||
| 25954317 |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 17, 2019 | Oct 14, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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. | 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 | 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. |
| Background |
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