MedTrace Logo

Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence

NCT02345447 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2018-05-11

No results posted yet for this study

Summary

The purpose of this study is to study whether a herbal-based medication is superior to placebo for prevention of acute otitis media in pre-school children with upper respiratory tract infection.

Conditions

  • Acute Otitis Media

Interventions

DRUG

Herbal-based medication

Aconitum napellus, Capsicum annuum; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum; Hydrastis canadensis; Iodum; Natrium tetraboracicum; Sambucus nigra; Sanguinaria canadensis

DRUG

Placebo

Aqueous ethanol solution non-distinguishable from verum

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Axel Franz, MD · University Hospital Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-10-31
Completion
2017-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT02345447 on ClinicalTrials.gov