Homeopathic Treatment of Post-acute COVID-19 Syndrome
Purpose
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.
Condition
- Post-acute Covid-19 Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 64 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, double-blind, placebo-controlled clinical trial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Both study medication and placebo are identical in appearance, odor, and taste. Statistician will be blinded as to treatment group.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Homeopathic Treatment Group |
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 |
|
|
Placebo Comparator Placebo Group |
Identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05104749
- Status
- Completed
- Sponsor
- Southwest College of Naturopathic Medicine
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.