Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

Heartburn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153552
• Other study ID #: Pro00037630
• Status: Completed
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: August 18, 2020

Study information

• Verified date: November 2021
• Source: Hawthorne Effect Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: August 18, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Dyspepsia
• Heartburn
• Indigestion

Intervention

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

Locations

Country	Name	City	State
United States	HLNatural, Inc.	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hawthorne Effect Inc.	HLNatural, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (27)

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11. Marshmallow: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-774/marshmallow

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19. Rational Phytotherapy: A Physician's Guide to Herbal Medicine. Schulz V, Hansel R, Tyler VE. Terry C. Telger, transl. 3rd ed. Berlin, GER: Springer, 1998.

2. Artichoke: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-842/artichoke

20. Marshmallow soothes cough. Bone K. Br J Phytother 1993;3(2):93.

21. Antitussive Activity of a Rhamnogalacturonan Isolated from the Roots of Althaea Officinalis L., Var. Robusta. Gabriela Nosálvá DMartin, Slovakia , Anna Strapková , Alžbeta Kardošová & Peter Capek Journal of Carbohydrate Chemistry Volume 12, 1993 - Issue 4-5

28. Functional dyspepsia in adults retrieved from https://www.uptodate.com/contents/functional-dyspepsia-in-adults#H4244969612

3. Chamomile Plant, Tea, and Oils: Health Benefits and Uses. (n.d.). Retrieved from https://www.webmd.com/diet/supplement-guide-chamomile#1

5. Dyspepsia (Indigestion). (2011, March 01). Retrieved from https://www.aafp.org/afp/2011/0301/p554.html

6. Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Cham: Springer.

8. Ginger Uses, Benefits & Dosage (n.d.). Retrieved from https://www.drugs.com/npp/ginger.html

Amsterdam JD, Li Y, Soeller I, Rockwell K, Mao JJ, Shults J. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. J Clin Psychopharmacol. 2009 Aug;29(4):378-82. doi: 10.1097/JCP.0b013e3181ac935c. — View Citation

Basch E, Ulbricht C, Hammerness P, Vora M. Marshmallow (Althaea officinalis L.) monograph. J Herb Pharmacother. 2003;3(3):71-81. — View Citation

Chandrasekaran CV, Sundarajan K, Gupta A, Srikanth HS, Edwin J, Agarwal A. Evaluation of the genotoxic potential of standardized extract of Glycyrrhiza glabra (GutGard™). Regul Toxicol Pharmacol. 2011 Dec;61(3):373-80. doi: 10.1016/j.yrtph.2011.10.002. Epub 2011 Oct 13. — View Citation

Giacosa A, Guido D, Grassi M, Riva A, Morazzoni P, Bombardelli E, Perna S, Faliva MA, Rondanelli M. The Effect of Ginger (Zingiber officinalis) and Artichoke (Cynara cardunculus) Extract Supplementation on Functional Dyspepsia: A Randomised, Double-Blind, and Placebo-Controlled Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:915087. doi: 10.1155/2015/915087. Epub 2015 Apr 14. — View Citation

Haniadka R, Saldanha E, Sunita V, Palatty PL, Fayad R, Baliga MS. A review of the gastroprotective effects of ginger (Zingiber officinale Roscoe). Food Funct. 2013 Jun;4(6):845-55. doi: 10.1039/c3fo30337c. Epub 2013 Apr 24. Review. — View Citation

Holtmann G, Adam B, Haag S, Collet W, Grünewald E, Windeck T. Efficacy of artichoke leaf extract in the treatment of patients with functional dyspepsia: a six-week placebo-controlled, double-blind, multicentre trial. Aliment Pharmacol Ther. 2003 Dec;18(11-12):1099-105. — View Citation

Hu ML, Rayner CK, Wu KL, Chuah SK, Tai WC, Chou YP, Chiu YC, Chiu KW, Hu TH. Effect of ginger on gastric motility and symptoms of functional dyspepsia. World J Gastroenterol. 2011 Jan 7;17(1):105-10. doi: 10.3748/wjg.v17.i1.105. — View Citation

Larkworthy W, Holgate PF. Deglycyrrhizinized liquorice in the treatment of chronic duodenal ulcer. A retrospective endoscopic survey of 32 patients. Practitioner. 1975 Dec;215(1290):787-92. — View Citation

Leidy NK, Farup C, Rentz AM, Ganoczy D, Koch KL. Patient-based assessment in dyspepsia: development and validation of Dyspepsia Symptom Severity Index (DSSI). Dig Dis Sci. 2000 Jun;45(6):1172-9. — View Citation

Raveendra KR, Jayachandra, Srinivasa V, Sushma KR, Allan JJ, Goudar KS, Shivaprasad HN, Venkateshwarlu K, Geetharani P, Sushma G, Agarwal A. An Extract of Glycyrrhiza glabra (GutGard) Alleviates Symptoms of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study. Evid Based Complement Alternat Med. 2012;2012:216970. doi: 10.1155/2012/216970. Epub 2011 Jun 16. — View Citation

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Villa-Rodriguez JA, Kerimi A, Abranko L, Tumova S, Ford L, Blackburn RS, Rayner C, Williamson G. Acute metabolic actions of the major polyphenols in chamomile: an in vitro mechanistic study on their potential to attenuate postprandial hyperglycaemia. Sci Rep. 2018 Apr 3;8(1):5471. doi: 10.1038/s41598-018-23736-1. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.