Anxiety Clinical Trial
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
Verified date | January 2022 |
Source | Arrae |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 35 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Citruslabs | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Arrae | Citruslabs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in IBS symptoms (bloating, heartburn and gas) | 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. | 4 weeks | |
Primary | Reduction in anxiety symptoms | 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. | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Completed |
NCT05881681 -
A Mindfulness Approach to UA for Afro-descendants
|
N/A | |
Active, not recruiting |
NCT04961112 -
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
|
N/A | |
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Completed |
NCT05980845 -
The Effect Nature Sounds and Music on Hemodialysis Patients
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Completed |
NCT05585749 -
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
|
N/A | |
Terminated |
NCT03272555 -
WILD 5 Wellness: A 30-Day Intervention
|
N/A | |
Recruiting |
NCT05997849 -
Development of a Multiplatform Mental Health Mobile Tool
|
N/A | |
Completed |
NCT06421233 -
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
|
N/A |