Periodic Fever SyndromeHOMPFAPANCT05995288
Homeopathic Treatment of Children Suffering From PFAPA
An observational study of Periodic Fever Syndrome, run by Michael Frass at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Periodic Fever Syndrome
- What is being tested?
- Homeopathic Globule
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2019to 8 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children were suffering from PFAPA for at least 6 months.
Who may be able to join
- Children suffering from fever with at least one of the symptooms of PFAPA besides fever
Who cannot join
- Parents not willing to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Periodic Fever Syndrome
- Being tested
- Homeopathic Globule
- Keywords
- PFAPA, periodic fever, homeopathy, Naranjo criteria
- Medical subject headings
- Hereditary Autoinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathic GlobuleDrug
Homeopathic globules were administered after careful anamnesis
| Study group | Role | What they receive |
|---|---|---|
| Children suffering from PFAPA | Children suffering from periodic fever, with at least one of the following symptoms: aphthous stomatitis, pharyngitis, cervical adenitis Receives: Drug: Homeopathic Globule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodic fever flares
Appearance of periodic fever flares
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 May 2019
- Primary completion31 Dec 2020
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodic Fever SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Frass
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Frass, Medical University of Vienna
- Investigators
- Peter Panhofer, MD, Study director, Sigmund Freud Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995288
- Sponsor's protocol ID
- 202308
- Acronym
- HOMPFAPA
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathic Treatment of Children Suffering From PFAPA: a Retrospective Case Series.
- ClinicalTrials.gov ID
- NCT05995288
- Acronym / sponsor ID
- HOMPFAPA / 202308
- Conditions
- Periodic Fever Syndrome
- Keywords
- PFAPA, periodic fever, homeopathy, Naranjo criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Michael FrassUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children suffering from PFAPA | – | Drug: Homeopathic GlobuleChildren suffering from periodic fever, with at least one of the following symptoms: aphthous stomatitis, pharyngitis, cervical adenitis |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children were suffering from PFAPA for at least 6 months.
Key inclusion criteria (1 listed)
- Children suffering from fever with at least one of the symptooms of PFAPA besides fever
Key exclusion criteria (1 listed)
- Parents not willing to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeopathic GlobuleHomeopathic globules were administered after careful anamnesis | Drug | Children suffering from PFAPA |
Primary outcome
Periodic fever flares
Time frame: 30 months
Appearance of periodic fever flares
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Panhofer, MD study director
Sigmund Freud Private University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodic Fever Syndrome, run by Michael Frass at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodic fever flares (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.