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NCT01721395 · ClinicalTrials.gov registry record · NA

Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents

A NA study of Cough, sponsored by Penn State University.

Completed
Registry status
NA
Development phase
120
Enrollment target
1
Study location

NCT01721395 is a NA study of Cough that has completed, run by Penn State University. The registered enrollment target is 120 participants, below the 212-participant average among 12 other Cough trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01721395, a NA study of Cough, has completed, sponsored by Penn State University.

COMPLETED
Registry status
NA
Development phase
120 participants
Enrollment target
1
Study location

Study Summary

Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. The US Food and Drug Administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussives, and expectorants should not be administered to children younger than 2 years of age due not only to lack of proven efficacy, but also because of important safety concerns. Honey, another method of soothing cough cannot be used in children \<1 year due to concerns for infantile botulism. A preparation from agave syrup has been created to address the need for an infant cough syrup. Although no studies have formally evaluated the use of agave nectar for nocturnal cough associated with Upper Respiratory Infections, the demulcent effect and sweet taste of agave nectar may provide some relief from cough in children.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Agave Syrup

Study Locations (1)

Pennsylvania

  • Penn State Hershey Medical Center - Hershey

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2013-01
Est. Completion 2014-03
Phase NA

Sponsor

Penn State University

219 total trials

What the Registry Record Tells You About NCT01721395

The ClinicalTrials.gov registry entry for NCT01721395 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 212-participant average among 12 other Cough trials with a reported enrollment target (43% lower). The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cough appearing as the primary indexed condition, and to 1 intervention - of which Agave Syrup is the first listed.

NCT01721395 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01721395 about?

NCT01721395 is a clinical study titled "Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents". Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. The US Food and Drug Administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussive...

What is the current status of trial NCT01721395?

This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2013-01. Estimated completion is 2014-03.

What conditions does trial NCT01721395 study?

This clinical trial studies the following conditions: Cough.

What interventions are being tested in trial NCT01721395?

The interventions under investigation include: Agave Syrup (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01721395?

This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01721395 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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