Post-acute Covid-19 SyndromePhase 3NCT05104749
Homeopathic Treatment of Post-acute COVID-19 Syndrome
A Phase 3 study testing Homeopathic Medication in people with Post-acute Covid-19 Syndrome, run by Southwest College of Naturopathic Medicine at 1 site in United States.
Trial summary
To determine whether an individually prescribed homeopathic medicine has an effect greater than a placebo and is a viable treatment option to improve fatigue and quality of life for patients suffering from the symptoms of Post-acute COVID-19 Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Post-acute Covid-19 Syndrome
- What is being tested?
- Homeopathic Medication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 22 Apr 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-64
- Any ethnicity
- Adequate cognitive function to be able to give informed consent
- Technologically competent to complete web forms and perform video calls
- Positive PCR test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2)
- Persistent fatigue for a minimum of 60 days since diagnosis of Covid-19.
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- A fatigue score above 21 in the Fatigue Assessment Scale upon enrollment
- Willing to fill out regular questionnaires
- Willing to use homeopathic medicines
Who cannot join
- Clinically significant kidney, heart, or hepatic impairment as determined by clinical judgment
- Previous hospitalization in ICU for Covid-19
- Diagnosis of Chronic Fatigue Syndrome, Fibromyalgia, or Lyme disease prior to Covid-19
- Chronic psychiatric illness or neurological illness prior to Covid-19 diagnosis Taking opioid analgesics, opioid dependence or undergoing treatment for substance abuse or addiction
- Taking steroid medication or immunosuppressive medications
- Suspected or confirmed pregnancy or breastfeeding
Show all 9Show fewer
- Active cancers
- Current treatment by a homeopathic practitioner
- Initiation of another treatment for Long Covid within the past 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest College of Naturopathic Medicine
Tempe, Arizona, 85282
About this study
Official title: Homeopathic Treatment of Post-acute COVID-19 Syndrome- A Pilot Randomized Controlled Trial
To determine whether an individually prescribed homeopathic medicine has an effect greater than a placebo and is a viable treatment option to improve fatigue and quality of life for patients suffering from the symptoms of Post-acute COVID-19 Syndrome. The researchers hope to achieve this goal by conducting a clinical trial that is scientifically rigorous and clinically relevant. Expected results of this pilot study will be to obtain sufficient experience and preliminary feasibility data to justify a larger clinical trial of this hypothesis.
Read the detailed description
The researchers objectives for the study are to: 1) identify efficient means of recruiting subjects, 2) test and refine the initial study design and treatment protocol, 3) evaluate the instruments for assessing treatment outcomes, 4) estimate sample sizes that will be required in the full-scale trial, 5) determine which homeopathic medicines are most often prescribed for this syndrome, and 6) determine whether there is a measurable effect size difference or positive trend in reduction of symptoms in patients treated with homeopathy.
- Conditions
- Post-acute Covid-19 Syndrome
- Being tested
- Homeopathic Medication, Placebo
- Keywords
- Long Covid
- Medical subject headings
- 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 MedicationDrug
Homeopathic medicines are prepared according to standardized methods as specified by the Homeopathic Pharmacopoeia of the United States (HPUS), which was mandated by Congress to regulate the manufacture of homeopathic medicines as part of the Food, Drug, and Cosmetics Act of 1939. All homeopathic medicines prescribed in this study must be found in the HPUS. For a complete list of homeopathic medicines, contact the researchers.
PlaceboOther
Inert lactose pellets
| Study group | Role | What they receive |
|---|---|---|
| Homeopathic Treatment Group | Experimental | Individualized homeopathic medicines on impregnated lactose pellets will be prescribed to each participant based on the totality of their physical, emotional, and mental symptoms. All medicines prescribed are listed in the Homeopathic Pharmacopoeia of the United States (HPUS) as outlined in the Food, Drug, and Cosmetics Act of 1939 Receives: Drug: Homeopathic Medication |
| Placebo Group | Placebo comparator | Identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessment Scale (FAS)
The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. Less than 22 indicates "normal" (i.e. healthy) levels of fatigue between 22 and 34 indicates mild-to-moderate fatigue 35 or more indicates severe fatigue (Hendricks et al., 2018).
Measured: Baseline, 4, 8 and 12 weeks
SF-36 Physical Composite Score (PCS)
Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores.
Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores.
Measured: Baseline and 4, 8, and 12 weeks
SF-36 Mental Composite Score (MCS)
Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores.
Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores.

Measured: Baseline and 4, 8, and 12 weeks
Secondary outcomes (4)
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool for assessing depression The PHQ-9 scores each of the 9 DSM-IV depression criteria as "0" (not at all) to "3" (nearly every day).
PHQ-9 scores range from 0 to 27, with scores of 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depression, respectively.
Measured: Baseline and 12 weeks
Measure Yourself Medical Outcomes Profile Symptom #1
The Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms.
The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health.
Measured: Baseline and 12 weeks
Measure Yourself Medical Outcomes Profile Symptom #2
The Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms.
The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health.
Measured: Baseline and 12 weeks
Patient Doctor Depth of Relationship (PDDR)
The Patient Doctor Depth of Relationship (PDDR) scale is an eight item, patient self-completed questionnaire designed to measure patient-doctor relational depth. A single overall depth-of-relationship score can be calculated, which ranges from 0 (no relationship) to 32 (very strong relationship).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start15 Sep 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-acute Covid-19 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Samueli Institute for Information Biology
- Responsible party
- Principal investigator, Elizabeth Rice, Southwest College of Naturopathic Medicine
- Investigators
- Elizabeth Rice, ND, Principal investigator, Southwest College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104749
- Sponsor's protocol ID
- 0012021
- Status last verified
- Nov 2023
- First submitted
- 28 Oct 2021
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathic Treatment of Post-acute COVID-19 Syndrome- A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05104749
- Acronym / sponsor ID
- 0012021
- Conditions
- Post-acute Covid-19 Syndrome
- Keywords
- Long Covid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Southwest College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- Samueli Institute for Information Biology
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Posted 22 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether an individually prescribed homeopathic medicine has an effect greater than a placebo and is a viable treatment option to improve fatigue and quality of life for patients suffering from the symptoms of Post-acute COVID-19 Syndrome. The researchers hope to achieve this goal by conducting a clinical trial that is scientifically rigorous and clinically relevant. Expected results of this pilot study will be to obtain sufficient experience and preliminary feasibility data to justify a larger clinical trial of this hypothesis.
Detailed description
The researchers objectives for the study are to: 1) identify efficient means of recruiting subjects, 2) test and refine the initial study design and treatment protocol, 3) evaluate the instruments for assessing treatment outcomes, 4) estimate sample sizes that will be required in the full-scale trial, 5) determine which homeopathic medicines are most often prescribed for this syndrome, and 6) determine whether there is a measurable effect size difference or positive trend in reduction of symptoms in patients treated with homeopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Homeopathic Treatment Group | Experimental | Drug: Homeopathic MedicationIndividualized homeopathic medicines on impregnated lactose pellets will be prescribed to each participant based on the totality of their physical, emotional, and mental symptoms. All medicines prescribed are listed in the Homeopathic Pharmacopoeia of the United States (HPUS) as outlined in the Food, Drug, and Cosmetics Act of 1939 |
| Placebo Group | Placebo comparator | Other: PlaceboIdentical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Ages 18-64
- Any ethnicity
- Adequate cognitive function to be able to give informed consent
- Technologically competent to complete web forms and perform video calls
- Positive PCR test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2)
Key exclusion criteria (9 listed)
- Clinically significant kidney, heart, or hepatic impairment as determined by clinical judgment
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 MedicationHomeopathic medicines are prepared according to standardized methods as specified by the Homeopathic Pharmacopoeia of the United States (HPUS), which was mandated by Congress to regulate the manufacture of homeopathic medicines as part of the Food, Drug, and Cosmetics Act of 1939. All homeopathic medicines prescribed in this study must be found in the HPUS. For a complete list of homeopathic medicines, contact the researchers. | Drug | Homeopathic Treatment Group |
| PlaceboInert lactose pellets | Other | Placebo Group |
Primary outcome
Fatigue Assessment Scale (FAS)
Time frame: Baseline, 4, 8 and 12 weeks
The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. Less than 22 indicates "normal" (i.e. healthy) levels of fatigue between 22 and 34 indicates mild-to-moderate fatigue 35 or more indicates severe fatigue (Hendricks et al., 2018).
SF-36 Physical Composite Score (PCS)
Time frame: Baseline and 4, 8, and 12 weeks
Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores.
SF-36 Mental Composite Score (MCS)
Time frame: Baseline and 4, 8, and 12 weeks
Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores. 
4 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and 12 weeks
Measure Yourself Medical Outcomes Profile Symptom #1
Time frame: Baseline and 12 weeks
Measure Yourself Medical Outcomes Profile Symptom #2
Time frame: Baseline and 12 weeks
Patient Doctor Depth of Relationship (PDDR)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Elizabeth Rice, ND principal investigator
Southwest College of Naturopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Homeopathic Medication in people with Post-acute Covid-19 Syndrome, run by Southwest College of Naturopathic Medicine at 1 site in United States.
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 9 inclusion and 9 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 Nov 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fatigue Assessment Scale (FAS) (time frame: Baseline, 4, 8 and 12 weeks). The study lists 3 primary outcomes in all. 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 Nov 2023.