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BАbykids Spray In Common Cold

NCT05819203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-08

Study results available
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Summary

The purpose of this post market clinical investigation is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo in children above 2 years.

Conditions

  • Common Cold
  • Rhinitis Viral

Interventions

DEVICE

Healsea Babykids

7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

DEVICE

Placebo

7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Sponsors & Collaborators

  • Lallemand Pharma AG

    lead INDUSTRY

Principal Investigators

  • Rada MARKOVA, MD · Medical Center, Sofia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2023-05-16
Completion
2023-05-16

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819203 on ClinicalTrials.gov