HOMPFAPA: Homeopathic Treatment of Children Suffering From PFAPA

• Sponsor: Michael Frass (Other)
• Overall Status: Completed
• CT.gov ID: NCT05995288
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Actual Duration (Months): 51.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Periodic Fever Syndrome	Drug: Homeopathic Globule

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 Design

• Study Type: Observational
• Actual Enrollment: 13 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Homeopathic Treatment of Children Suffering From PFAPA: a Retrospective Case Series.
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Aug 8, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Periodic fever flares [30 months]

   Appearance of periodic fever flares

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael Frass	Wien		Austria	1100

Sponsors and Collaborators

• Michael Frass

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Frass, MD, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05995288
• Other Study ID Numbers: 202308
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 18, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael Frass, MD, Medical University of Vienna: PFAPA; periodic fever; homeopathy; Naranjo criteria
• Additional relevant MeSH terms: Familial Mediterranean Fever

Study Results

No Results Posted as of Aug 18, 2023