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Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05197413
Recruitment Status : Completed
First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Collaborator:
Citruslabs
Information provided by (Responsible Party):
Arrae

Brief Summary:
This is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of IBS (such as bloating, gas, heartburn, and other symptoms).

Condition or disease Intervention/treatment Phase
IBS - Irritable Bowel Syndrome Anxiety Dietary Supplement: Arrae bloat supplement Not Applicable

Detailed Description:
It is hypothesized that the dietary supplement marketed as "Arrae Bloat" will improve subjective wellbeing in trial participants. It is further hypothesized that a second dietary supplement marketed as "Arrae Calm" will support the effects of "Arrae Bloat", while reducing stress, anxiety and panic and promoting restful sleep and easing tension in the body, which has previously been reported in customer feedback studies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arrae Bloat supplement
The "Bloat" capsules are a blend of 5 herbs and a fruit-based digestive enzyme that target the cause for IBS symptoms.
Dietary Supplement: Arrae bloat supplement
The supplement contains organic dandelion root extract, organic lemon balm herb top extract, organic peppermint leaf extract, organic bromelain, organic slippery elm inner bark extract. The capsule itself is made of cellulose, which is not a main active ingredient.




Primary Outcome Measures :
  1. Reduction in IBS symptoms (bloating, heartburn and gas) [ Time Frame: 4 weeks ]
    Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in IBS symptoms between baseline and study intervention period.

  2. Reduction in anxiety symptoms [ Time Frame: 8 weeks ]
    Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in anxiety symptoms between baseline and study intervention period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female over 18 years old
  • Self-reported (undiagnosed) IBS symptoms, such as self-reported abdominal pain, gas production and bloating after meals, heartburn after meals
  • Must be in good health (don't report any medical conditions asked in the screening questionnaire)
  • Following a stable, consistent diet regimen
  • Agree to refrain from any lifestyle changes that may affect their GI tract and IBS symptoms for the duration of the study
  • May have self-reported sleep issues
  • May have self-reported mild anxiety/depression
  • May have self-reported occasional panic attacks

Exclusion Criteria:

  • Prior prescriptions for IBS
  • Current IBS treatment (e.g. proton pump inhibitors, laxatives)
  • Follow an extreme diet intervention
  • Experienced severe weight loss in the past 3 months prior to study participation
  • Antibiotic usage within 3 months prior of study participation
  • Usage any medication or herbal remedies which can affect the GI tract
  • Food intolerances/allergies
  • Pineapple sensitivity/allergy
  • Taking cortisol lowering prescription medication
  • Has any of the following medical conditions:

History of GI tract cancers Celiac disease / gluten intolerance GI bleeding Rectal bleeding Heme-positive stool Iron-deficiency anemia Systemic signs of infection Insomnia Moderate to severe depression/anxiety Moderate to severe panic attacks

- Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05197413


Locations
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United States, California
Citruslabs
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Arrae
Citruslabs
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Responsible Party: Arrae
ClinicalTrials.gov Identifier: NCT05197413    
Other Study ID Numbers: 20219Arrae
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Heartburn
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive