Phase 3
N=77
Homeopathic Treatment of Post-acute COVID-19 Syndrome
Post-acute Covid-19 Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05104749 ↗Enrolled (actual)
77
Serious AEs
2.6%
Results posted
Nov 2023
Primary outcome: Primary: Fatigue Assessment Scale (FAS) — 32.9; 31.4; 29.0; 27.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Homeopathic Medication (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Southwest College of Naturopathic Medicine
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Assessment Scale (FAS) |
32.9; 31.4; 29.0; 27.4; 29.4; 27.3 | — |
| PRIMARY SF-36 Physical Composite Score (PCS) |
51.8; 51.1; 55.0; 58.7; 55.0; 61.2 | — |
| PRIMARY SF-36 Mental Composite Score (MCS) |
43.0; 50.2; 47.8; 54.7; 49.8; 57.3 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
7.8; 6.8 | — |
| SECONDARY Measure Yourself Medical Outcomes Profile Symptom #1 |
1.3; 1.6 | — |
| SECONDARY Measure Yourself Medical Outcomes Profile Symptom #2 |
1.0; 1.7 | — |
| SECONDARY Patient Doctor Depth of Relationship (PDDR) |
24.1; 24.3 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
- A fatigue score above 21 in the Fatigue Assessment Scale upon enrollment
- Willing to fill out regular questionnaires
- Willing to use homeopathic medicines
Exclusion Criteria
- 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
- Active cancers
- Current treatment by a homeopathic practitioner
- Initiation of another treatment for Long Covid within the past 2 months
Data sourced from ClinicalTrials.gov (NCT05104749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.