Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

NCT04153552 | Completed

• 1 other identifier: Pro00037630
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Indigestion; Heartburn

Keywords

Natural; Supplement

Outcome Measures

Primary Outcomes (1)

• 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 (3)

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

  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.

• Outcomes of all adverse events while consuming HLNatural Supplement

  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

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

Study Arms (1)

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.

Dietary Supplement: HLNatural, Inc. Upset Stomach Relief

Interventions

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

Study Participants who Suffer from Heartburn or indigestion

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawthorne Effect Inc.: lead
• HLNatural, Inc.: collaborator

Study Sites (1)

HLNatural, Inc.

New York, New York, 10017, United States

Location

Related Publications (27)

• 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.

  BACKGROUND

• 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.

  PMID: 25954317 BACKGROUND

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

  BACKGROUND

• Holtmann G, Adam B, Haag S, Collet W, Grunewald 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. doi: 10.1046/j.1365-2036.2003.01767.x.

  PMID: 14653829 BACKGROUND

• 10. Licorice: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-881/licorice

  BACKGROUND

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

  BACKGROUND

• 12. McMahon, G. (2019). Comparison of a Numeric and a Descriptive Pain Scale in the Occupational Medicine Setting. Retrieved from https://scholarworks.sjsu.edu/etd_doctoral/98/

  BACKGROUND

• 13. The R Project for Statistical Computing. (n.d.). Retrieved from https://www.R-project.org/.

  BACKGROUND

• 14. Vitamin C. (2017, October 18). Retrieved from https://www.mayoclinic.org/drugs-supplements-vitamin-c/art-20363932

  BACKGROUND

• 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. doi: 10.1023/a:1005558204440.

  PMID: 10877234 BACKGROUND

• 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.

  PMID: 22019788 BACKGROUND

• 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.

  PMID: 772652 BACKGROUND

• 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.

  PMID: 21747893 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• Basch E, Ulbricht C, Hammerness P, Vora M. Marshmallow (Althaea officinalis L.) monograph. J Herb Pharmacother. 2003;3(3):71-81. No abstract available.

  PMID: 15277059 BACKGROUND

• 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.

  PMID: 23612703 BACKGROUND

• 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.

  PMID: 21218090 BACKGROUND

• Saller R, Iten F, Reichling J. [Dyspeptic pain and phytotherapy--a review of traditional and modern herbal drugs]. Forsch Komplementarmed Klass Naturheilkd. 2001 Oct;8(5):263-73. doi: 10.1159/000057236. German.

  PMID: 11694755 BACKGROUND

• 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.

  PMID: 29615674 BACKGROUND

• 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.

  PMID: 19593179 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Dyspepsia; Heartburn

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Soyona Rafatjah, MD

  Hawthorne Effect Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: November 6, 2019
• Study Start: October 16, 2019
• Primary Completion: August 18, 2020
• Study Completion: August 18, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

US (1)