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
Verified date | November 2021 |
Source | Hawthorne Effect Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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.) |
Country | Name | City | State |
---|---|---|---|
United States | HLNatural, Inc. | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hawthorne Effect Inc. | HLNatural, Inc. |
United States,
1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/
10. Licorice: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-881/licorice
11. Marshmallow: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-774/marshmallow
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/
13. The R Project for Statistical Computing. (n.d.). Retrieved from https://www.R-project.org/.
14. Vitamin C. (2017, October 18). Retrieved from https://www.mayoclinic.org/drugs-supplements-vitamin-c/art-20363932
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
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. Review. German. — View Citation
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
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06094062 -
Smartphone App-assisted PPI
|
N/A | |
Completed |
NCT00481949 -
Assessment of Gastro-esophageal Reflux Using Endo-Flip vs Bravo
|
N/A | |
Completed |
NCT04560595 -
Remote Guided Caffeine Reduction
|
N/A | |
Recruiting |
NCT01696734 -
Domperidone in Treating Patients With Gastrointestinal Disorders
|
Phase 3 | |
Recruiting |
NCT02105090 -
Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
|
Phase 4 | |
Completed |
NCT01338077 -
Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease
|
Phase 3 | |
Completed |
NCT01005251 -
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
|
Phase 2 | |
Terminated |
NCT00536328 -
What is the Predictive Value of the Reflux Impact Scale
|
N/A | |
Completed |
NCT00382577 -
Efficacy and Safety of Itopride vs Placebo in Heartburn
|
Phase 3 | |
Completed |
NCT00236197 -
E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
|
Phase 3 | |
Completed |
NCT00236184 -
E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
|
Phase 3 | |
Completed |
NCT00236392 -
A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD)
|
Phase 3 | |
Recruiting |
NCT06075082 -
The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
|
N/A | |
Completed |
NCT05247333 -
Implementation of a Minor Ailment Service in Community Pharmacy Practice
|
N/A | |
Recruiting |
NCT02277886 -
Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances
|
Phase 4 | |
Completed |
NCT01249651 -
To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
|
Phase 4 | |
Completed |
NCT00588939 -
Confocal Laser Microscopy in Non Erosive Reflux Disease
|
N/A | |
Completed |
NCT00206024 -
Acid-Associated Heartburn Symptoms and Dose of Esomeprazole
|
Phase 4 | |
Recruiting |
NCT05976165 -
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
|
N/A | |
Not yet recruiting |
NCT06098742 -
Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers
|
N/A |