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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: Completed NA study of Cough, sponsored by Penn State University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in cough frequency between the first night and the end of the second night. Parents/caregivers will complete a Pediatric Cough Questionnaire (a subjective parent report of cough) using a 0-6 point Likert scale with 0=not at all to 6=extremely often to assess frequency of cough. The same parent/caregiver that completed the questionnaire in the clinic will be asked to complete the questionnaire during the follow-up telephone call.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Agave Syrup
Study Locations (1)
Pennsylvania
- Penn State Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-03 |
| Phase | NA |
What the finished NCT01721395 record still lists
NCT01721395 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 212-participant average among 12 other Cough trials with a reported enrollment target (43% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cough
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01721395's enrollment target sits among peer trials
120 5th of 12 higher than 8 of 12 other Cough trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cough trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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