Homeopathic Treatment of Post-acute COVID-19 Syndrome

Southwest College of Naturopathic Medicine

Status and phase: Completed; Phase 3

Conditions: Post-acute Covid-19 Syndrome

Treatments: Other: Placebo; Drug: Homeopathic Medication

Study type: Interventional

Funder types: Other

Identifiers

NCT05104749

0012021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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77 participants in 2 patient groups, including a placebo group

Homeopathic Treatment Group

Experimental group

Description:

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

Treatment:

Drug: Homeopathic Medication

Placebo Group

Placebo Comparator group

Description:

Identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines.

Treatment:

Other: Placebo