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Post Market Clinical Follow-Up Study - Medical Device KalobaGOLA ( PMCF )

NCT05985837 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-04-17

No results posted yet for this study

Summary

The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaGola (oral spray and tablets) in children, adolescents and adults with sore throat and /or pharyngitis. The main questions it aims to answer are:

* Is the product effective in the treatment of sore throat / pharyingits?
* Is the product safe?

After buying the product, participants will be asked to fill in a questionnaire, in order to:

1. Assess the sore throat symptoms before the use of the spray or tablets.
2. Assess the resolution of sore throat / pharyngitis symptoms after the use of the spray or tablets.
3. Describe the adverse effect(s)/problem(s) observed while using the product (if any).

Conditions

  • Sore-throat
  • Pharyngitis

Interventions

DEVICE

KalobaGOLA spray (1)

Oral spray, 2-4 spray, till 8 times per day

DEVICE

KalobaGOLA spray (2)

Oral spray, 2-4 spray, till 4 times per day

DEVICE

KalobaGOLA tablets

1 tablets, 6 times per day

Sponsors & Collaborators

  • Schwabe Pharma Italia

    lead INDUSTRY

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Italy

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 NCT05985837 on ClinicalTrials.gov