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Dietary Supplement

Active Product 1.1 for Abdominal Pain

N/A
Waitlist Available
Led By Emily K. Pauli, PharmD
Research Sponsored by Radicle Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will test how health and wellness products affect gut health and overall health outcomes in a fair and unbiased manner.

Who is the study for?
This trial is for individuals experiencing gastrointestinal disorders, abdominal pain, or digestion issues. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to join.Check my eligibility
What is being tested?
The study tests a new wellness product (Radicle GI Health Active Study Product 1.1) against a placebo to see if it improves gastrointestinal health and related outcomes. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real product.See study design
What are the potential side effects?
Potential side effects are not listed but may include reactions typical of GI treatments such as nausea, discomfort, or changes in bowel habits. The exact side effects will depend on the nature of the active study product.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing to take a study drug without knowing if it's active or a placebo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in GI (Gastrointestinal) Health (1)
Change in GI (Gastrointestinal) Health (2)
Change in GI (Gastrointestinal) Health (3)
+3 more
Secondary outcome measures
Change in GI-related Quality of Life (QOL)
Change in feelings of anxiety
Change in mood (emotional distress-depression)
+9 more
Other outcome measures
Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Product 1.1Experimental Treatment1 Intervention
GI Health Product Form 1 - active product 1
Group II: Placebo Control 1Placebo Group1 Intervention
GI Health Product Form 1 - control

Find a Location

Who is running the clinical trial?

Radicle ScienceLead Sponsor
19 Previous Clinical Trials
37,593 Total Patients Enrolled
1 Trials studying Abdominal Pain
2,180 Patients Enrolled for Abdominal Pain
Emily K. Pauli, PharmDPrincipal InvestigatorRadicle Science, Inc
15 Previous Clinical Trials
30,066 Total Patients Enrolled
1 Trials studying Abdominal Pain
2,180 Patients Enrolled for Abdominal Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to be a part of this research study?

"Individuals aged between 21 and 105 with a gastrointestinal ailment are eligible to participate in this trial, which aims to admit a total of 500 participants."

Answered by AI

Are patients currently able to enroll in this ongoing clinical trial?

"Affirmative. Information available on clinicaltrials.gov indicates that this particular medical trial is actively enrolling participants. The trial was initially uploaded on March 19, 2024, and the most recent update occurred on April 18, 2024. The study aims to recruit a total of 500 patients from one designated site."

Answered by AI

What is the current number of individuals who are being enrolled in this clinical investigation?

"Affirmative. Data available on clinicaltrials.gov highlights that this research endeavor is actively pursuing eligible participants. The trial was initially disclosed on March 19, 2024, and its latest update was recorded on April 18, 2024. A total of 500 individuals are being sought from a singular site for inclusion in the study."

Answered by AI

What are the specific goals and objectives of this research study?

"According to data provided by the clinical trial sponsor, Radicle Science, the main focus of this study will be on assessing alterations in GI (Gastrointestinal) Health over a period of 6 weeks. Additionally, secondary outcomes under scrutiny comprise identifying Minimal Clinically Important Differences (MCID) in GI Health for various parameters including Gastrointestinal Constipation intensity based on PROMIS scale 5-45; where higher scores indicate more severe constipation symptoms and Belly Pain severity measured on a scale from 2-25; with elevated values indicating increased abdominal discomfort. Furthermore, Gas and Bloating levels ranging between 2 to 60 are also"

Answered by AI

Is there an age limit of 40 or younger for potential participants in this study?

"To be eligible for this research, individuals between the ages of 21 and 105 are sought. There are separate studies available for those under 18 and over 65 years old: 18 studies cater to pediatric patients while there are 20 trials tailored towards elderly participants."

Answered by AI
~0 spots leftby Jun 2024