Homeopathic Treatment of Children Suffering From PFAPA (HOMPFAPA)

August 15, 2023 updated by: Michael Frass

Homeopathic Treatment of Children Suffering From PFAPA: a Retrospective Case Series.

Periodic fever, aphthous stomatitis, pharyngitis, cervical adenitis (PFAPA) syndrome is frequently diagnosed in young children. Fevers recurring at a nearly predictable rate every three to eight weeks are the signature symptom of PFAPA syndrome. PFAPA is an acquired autoinflammatory disorder, which recurs in association with at least one sign of aphthous stomatitis, pharyngitis, and cervical lymph node enlargement. The aim of this retrospective case report is to gain an impression of the course of disease during individualized homeopathic treatment in children suffering from PFAPA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this retrospective study, the investigators collected the history and symptoms of 13 consecutive PFAPA patients. The investigators also described the individually chosen homeopathic medicinal products (HMPs) used, as well as the course of the disease. Clinical outcome of case reports was assessed using the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory". Eight points are taken as the threshold for the possible correlation between homeopathic therapy and improvement of symptoms or cure in chronic cases

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1100
        • Michael Frass

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children were suffering from PFAPA for at least 6 months.

Description

Inclusion Criteria:

Children suffering from fever with at least one of the symptooms of PFAPA besides fever

Exclusion Criteria:

Parents not willing to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children suffering from PFAPA
Children suffering from periodic fever, with at least one of the following symptoms: aphthous stomatitis, pharyngitis, cervical adenitis
Drug: Homeopathic Globule
Homeopathic globules were administered after careful anamnesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodic fever flares
Time Frame: 30 months
Appearance of periodic fever flares
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Frass

Investigators

  • Study Director: Peter Panhofer, MD, Sigmund Freud Private University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

August 8, 2023

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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