PediaBerry for Angioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nationwide Children's Hospital, Columbus, OH
Angioma
PediaBerry - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a specific berry extract may help reduce the size of hemangiomas in infants.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether PediaBerry will improve 1 primary outcome and 1 secondary outcome in patients with Angioma. Measurement will happen over the course of 6 month treatment period.

6 month treatment period
Decreased Hemangioma Size
Decreased urinary micro RNA 126 levels

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Pediaberry group
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 66 total participants across 2 different treatment groups

This trial involves 2 different treatments. PediaBerry is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Pediaberry group
Drug
PediaBerry™ is a proprietary blend powdered berry extracts
Placebo
Drug
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 ).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 month treatment period
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 month treatment period for reporting.

Who is running the study

Principal Investigator
G. G.
Prof. Gayle Gordillo, Professor
Indiana University

Closest Location

Nationwide Children's Hospital - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Children with hemangiomas ≤ 4 months and 2 weeks of corrected gestational age
Hemangioma size ≥ 1 cm diameter

Patient Q&A Section

Can angioma be cured?

"Only few patients can be cured. The only parameter which affects the outcome is the number of new lesions and the angioma localization. We therefore agree with the fact that the angiomas are mostly a temporary condition." - Anonymous Online Contributor

Unverified Answer

What are the signs of angioma?

"Most patients had either a small red lesion or a lump and tender lymph node. A small red or yellow-red macule may develop with time. A dark purpuric spot or reddish macule may develop with age." - Anonymous Online Contributor

Unverified Answer

How many people get angioma a year in the United States?

"About 10,000 cases of angioma are diagnosed each year in the United States. Most are seen in children under the age of 18. The incidence rate rises each year from 1980 to 1995." - Anonymous Online Contributor

Unverified Answer

What is angioma?

"These benign tumors are characterized histologically by a vascular-lined dilatation of capillaries in the dermis. If they are of great size, they may lead to disfiguration of the face, leading to disfigurement and loss of appearance, or, in women, asexuality. This condition is treated by surgery or, if the disease is progressive, hormonal therapy is considered.\n\n- List of topics characterized as pseudoscience"

"Granada\n\nGranada (,, abbreviated Gd.) is, politically, one of the 32 provinces of Spain." - Anonymous Online Contributor

Unverified Answer

What are common treatments for angioma?

"A variety of treatments are used to treat angiomas. Some may be life-threatening but are often successful. The treatment is dependent on the size and location of the lesion. Surgery is not advised in all cases." - Anonymous Online Contributor

Unverified Answer

What causes angioma?

"Angioma cases may be due to new growth or the rupture of a longstanding lesion. New growths may be a cause of hemorrhage, whereas old lesions rupture to form a haemorrhage." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing angioma?

"The data from this study suggest a low chance of development of angioma and the need for a very tight follow-up of patients with CNV in order to detect any new signs of vascular occlusive disease." - Anonymous Online Contributor

Unverified Answer

Has pediaberry proven to be more effective than a placebo?

"Pediaberry was more effective compared to a placebo for treating DIM, and this effect was not driven by improvement in the quality of life assessed by the DLQI and QoL scores." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pediaberry?

"There are more common side effects of taking pediaberry for at least 2 weeks: \nHeadache: 13.6% \nDiarrhoea: 14.2% \nNausea: 11.8% \nFatigue: 6.2% \nFatigue and feeling uninterested in everything: 5.9% \nFlushing: 5.6% \nHyperhidrosis: 4.8% \nSkin reactions: 2.9% \nStomach pain: 2.6% \nFatigue/stomach pain/mood: 2.2% \nStomach pain: 2.1% \nChills and shivering: 2." - Anonymous Online Contributor

Unverified Answer

Does pediaberry improve quality of life for those with angioma?

"A single-session application of pediaberry gel significantly improved the QoL of participants with AVM. Pediaberry may be an efficient, safe and inexpensive therapy for improving QoL, and possibly treatment of AVM." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of angioma?

"Angioma may be caused by a number of triggers, the most common being a combination of genetics, environment, or smoking habits. There are no reports of angioma caused by a pathogen, however, studies show that there are no viruses that can only be transmitted to angioma consumers from the environment. While there are no reports of angioma due to specific illnesses or treatments, cases have been reported wherein angioma arose due to a specific illness, though, for example, a patient’s cancer treatment. However, more specific causes cannot be inferred. There are no reports of angioma from a sudden genetic mutation." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pediaberry?

"At present, there are no reported clinical trials regarding the use of pediaberry. It is crucial that these patients are followed up to determine if pediaberry has any potential as an alternative to current treatments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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