Adjustment Reaction With Physical SymptomsLONGCOVIHOMNCT06002230
Use of Homeopathy in Patients Suffering From Long COVID-19
An observational study of Adjustment Reaction With Physical Symptoms, run by Michael Frass at 1 site in Austria.
Trial summary
In some patients, coronavirus (COVID-19) can cause symptoms that last weeks or even months after the infection has gone. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to Long-COVID-19 patients with previously confirmed symptomatic SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Adjustment Reaction With Physical Symptoms
- What is being tested?
- Homeopathic medicines
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 5 Jan 2021to 10 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 18 to 100 years
- Women only
- Adult, Older adult
Study population: Patients suffering from Long COVID-19 symptoms following recovery from SARS-CoV-2 infection.
Who may be able to join
- Long COVID-19 symptoms following recovery from SARS-CoV-2 infection
Who cannot join
- Patients not signing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Homeopathy in Patients Suffering From Long COVID-19 (LONGCOVIHOM): A Retrospective Case Series
In some patients, coronavirus (COVID-19) can cause symptoms that last weeks or even months after the infection has gone. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to Long-COVID-19 patients with previously confirmed symptomatic SARS-CoV-2 infection.
Read the detailed description
All patients had been tested positive for SARS-CoV-2 before having developed Long-COVID-19 symptoms. Several testing methods were carried out in each patient to analyze a SARS-CoV-2 infection. For a confirmed infection, at least 3 out of these 5 tests had to be positive. Tests for the orthomyxoviruses influenza A and B, human metapneumovirus (hMPV) and paramyxoviruses were negative unless stated otherwise.
The homeopathic physician treated all Long-COVID-19 patients by individualized homeopathy. Repertorization of the symptoms of the current pandemic and a search in the current homeopathic literature on COVID-19 was performed using computer program. All available homeopathic medicinal products (HMPs) could be chosen by the treating physician.
Modified MONARCH criteria were assessed post hoc by all authors. Deviations were solved by discussion in person. Clinical outcome of case reports was evaluated using the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory". Eight points is assumed as the limit for potential correlation between homeopathic therapy and amelioration of the symptoms or healing in chronic cases.
- Being tested
- Homeopathic medicines
- Keywords
- Complementary therapy, Homeopathy, COVID-19, Long-COVID-19, SARS-CoV-2
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathic medicinesDrug
Also called Homeopathic medicinal products
Globules were administered orally..
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with individualized homeopathy | Patients suffering from symptoms of Long COVID-19 were treated with individualized homeopathy. Receives: Drug: Homeopathic medicines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Naranjo criteria
10 Naranjo criteria are evaluated, eight points is assumed as the limit for potential correlation between homeopathic therapy and amelioration of the symptoms or healing in chronic cases.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start5 Jan 2021
- Primary completion19 Oct 2021
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjustment Reaction With Physical SymptomsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Frass
- Sponsor type
- University, hospital or other
- Collaborators
- Sigmund Freud PrivatUniversitat
- Responsible party
- Sponsor-investigator, Michael Frass, Medical University of Vienna
- Investigators
- Michael Frass, MD, Study director, Institute for Homeopathic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002230
- Sponsor's protocol ID
- 111
- Acronym
- LONGCOVIHOM
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Homeopathy in Patients Suffering From Long COVID-19 (LONGCOVIHOM): A Retrospective Case Series
- ClinicalTrials.gov ID
- NCT06002230
- Acronym / sponsor ID
- LONGCOVIHOM / 111
- Keywords
- Complementary therapy, Homeopathy, COVID-19, Long-COVID-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Michael FrassUniversity, hospital or other
- Collaborators
- Sigmund Freud PrivatUniversitat
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 21 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.
In some patients, coronavirus (COVID-19) can cause symptoms that last weeks or even months after the infection has gone. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to Long-COVID-19 patients with previously confirmed symptomatic SARS-CoV-2 infection.
Detailed description
All patients had been tested positive for SARS-CoV-2 before having developed Long-COVID-19 symptoms. Several testing methods were carried out in each patient to analyze a SARS-CoV-2 infection. For a confirmed infection, at least 3 out of these 5 tests had to be positive. Tests for the orthomyxoviruses influenza A and B, human metapneumovirus (hMPV) and paramyxoviruses were negative unless stated otherwise.
The homeopathic physician treated all Long-COVID-19 patients by individualized homeopathy. Repertorization of the symptoms of the current pandemic and a search in the current homeopathic literature on COVID-19 was performed using computer program. All available homeopathic medicinal products (HMPs) could be chosen by the treating physician.
Modified MONARCH criteria were assessed post hoc by all authors. Deviations were solved by discussion in person. Clinical outcome of case reports was evaluated using the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory". Eight points is assumed as the limit for potential correlation between homeopathic therapy and amelioration of the symptoms or healing in chronic cases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with individualized homeopathy | – | Drug: Homeopathic medicinesPatients suffering from symptoms of Long COVID-19 were treated with individualized homeopathy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from Long COVID-19 symptoms following recovery from SARS-CoV-2 infection.
Key inclusion criteria (1 listed)
- Long COVID-19 symptoms following recovery from SARS-CoV-2 infection
Key exclusion criteria (1 listed)
- Patients not signing 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 medicinesAlso: Homeopathic medicinal productsGlobules were administered orally.. | Drug | Patients treated with individualized homeopathy |
Primary outcome
Modified Naranjo criteria
Time frame: 3 days
10 Naranjo criteria are evaluated, eight points is assumed as the limit for potential correlation between homeopathic therapy and amelioration of the symptoms or healing in chronic cases.
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 22 Aug 2023.
- Individual participant dataSharing planned: Undecided
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.
Michael Frass, MD study director
Institute for Homeopathic Research
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 Adjustment Reaction With Physical Symptoms, 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 22 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?
Modified Naranjo criteria (time frame: 3 days). 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 22 Aug 2023.