IndigestionNCT04153552
Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn
A study testing HLNatural, Inc. Upset Stomach Relief in people with Indigestion and Heartburn, run by Hawthorne Effect Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indigestion, Heartburn
- What is being tested?
- HLNatural, Inc. Upset Stomach Relief
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 18 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Indigestion, Heartburn
- Being tested
- HLNatural, Inc. Upset Stomach Relief
- Keywords
- Natural, Supplement
- Medical subject headings
- Dyspepsia, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLNatural, Inc. Upset Stomach ReliefDietary supplement
Supplement to take with mild to moderate indigestion. The degree of your indigestion pre and post will be recorded
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: HLNatural, Inc. Upset Stomach Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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
Participants will be asked to report any adverse events that the subject experiences throughout the study.
Measured: 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.
Measured: The time point will be evaluated from baseline to thoughout the trial up 60 days or 3 episodes of indigestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start16 Oct 2019
- Primary completion18 Aug 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for IndigestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawthorne Effect Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- HLNatural, Inc.
- Responsible party
- Sponsor
- Investigators
- Soyona Rafatjah, MD, Principal investigator, Hawthorne Effect Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153552
- Sponsor's protocol ID
- Pro00037630
- Status last verified
- Nov 2021
- First submitted
- 13 Sep 2019
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once the trial is completed and the data has been analyzed then a decision will be made on how to use the data.
Publications
1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/
2. Artichoke: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-842/artichoke
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.
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.
PubMed 259543178. Ginger Uses, Benefits & Dosage (n.d.). Retrieved from https://www.drugs.com/npp/ginger.html
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.
PubMed 1465382910. 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
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.
PubMed 10877234Chandrasekaran 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.
PubMed 22019788
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04153552
- Acronym / sponsor ID
- Pro00037630
- Conditions
- Indigestion, Heartburn
- Keywords
- Natural, Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Hawthorne Effect Inc.University, hospital or other
- Collaborators
- HLNatural, Inc.
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Participants who Suffer from Heartburn or indigestion | Other | Dietary Supplement: HLNatural, Inc. Upset Stomach ReliefSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLNatural, Inc. Upset Stomach ReliefSupplement to take with mild to moderate indigestion. The degree of your indigestion pre and post will be recorded | Dietary supplement | Study Participants who Suffer from Heartburn or indigestion |
Primary outcome
Outcomes of the severity and reduction of indigestion while consuming HLNatural Supplement.
Time frame: The improvements in symptoms will be evaluated from baseline.
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.
3 secondary outcomes
Outcomes of time to relief or to alternative treatment while taking HLNatural Supplement
Time frame: 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
Time frame: 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
Time frame: The time point will be evaluated from baseline to thoughout the trial up 60 days or 3 episodes of indigestion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Background1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/
- Background2. Artichoke: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-842/artichoke
- Background3. Chamomile Plant, Tea, and Oils: Health Benefits and Uses. (n.d.). Retrieved from https://www.webmd.com/diet/supplement-guide-chamomile#1
- Background5. Dyspepsia (Indigestion). (2011, March 01). Retrieved from https://www.aafp.org/afp/2011/0301/p554.html
- Background6. Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Cham: Springer.
- Background: PubMed 25954317Giacosa 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.
- Background8. Ginger Uses, Benefits & Dosage (n.d.). Retrieved from https://www.drugs.com/npp/ginger.html
- Background: PubMed 14653829Holtmann 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.
- Background10. Licorice: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-881/licorice
- Background11. Marshmallow: Uses, Side Effects, Interactions, Dosage, and Warning. (n.d.). Retrieved from https://www.webmd.com/vitamins/ai/ingredientmono-774/marshmallow
- Background12. 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/
- Background13. The R Project for Statistical Computing. (n.d.). Retrieved from https://www.R-project.org/.
- Individual participant dataSharing planned: Undecided. Once the trial is completed and the data has been analyzed then a decision will be made on how to use the data.
Related trials for Indigestion
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
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Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
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RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soyona Rafatjah, MD principal investigator
Hawthorne Effect Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLNatural, Inc. Upset Stomach Relief in people with Indigestion and Heartburn, run by Hawthorne Effect Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcomes of the severity and reduction of indigestion while consuming HLNatural Supplement. (time frame: The improvements in symptoms will be evaluated from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153552, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.