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Natural Extract
PediaBerry for Hemangioma (Pediaberry Trial)
Phase < 1
Waitlist Available
Led By Gayle Gordillo, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month treatment period
Awards & highlights
Summary
This trial tests PediaBerry™, a powdered mix of berry extracts, on infants with hemangiomas. The treatment is applied on the skin and given orally to help reduce these benign growths.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month treatment period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decreased Hemangioma Size
Secondary outcome measures
Decreased urinary micro RNA 126 levels
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pediaberry groupExperimental Treatment1 Intervention
PediaBerry™ is a proprietary blend powdered berry extracts
Group II: PlaceboPlacebo Group1 Intervention
Placebo: powdered sugar plus McCormick Color from Nature Food Colors Berry and Sky Blue powdered food color (https://www.mccormick.com/spices-and-flavors/extracts-and-food-colors/food-colors/color-from-nature-assorted-food-color ).
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
997 Previous Clinical Trials
1,095,582 Total Patients Enrolled
Gayle GordilloLead Sponsor
5 Previous Clinical Trials
134 Total Patients Enrolled
1 Trials studying Hemangioma
68 Patients Enrolled for Hemangioma
National Institute of General Medical Sciences (NIGMS)NIH
273 Previous Clinical Trials
247,996 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have hemangiomas (abnormal clusters of blood vessels) located in the diaper area, and the study product may get wiped off or contaminated during diaper changes.Children who have had hemangiomas in the past and were treated for them.Children with hemangiomas that can harm their life or development of important body parts.Children who are allergic to blueberries or any type of berry.Infants younger than 4 months and 2 weeks, who have hemangiomas (abnormal growth of blood vessels) and were born prematurely.If you are a breastfeeding child and your mother is taking beta blocker medication, you cannot participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Pediaberry group
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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