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NCT Number: NCT05104749

Homeopathic Treatment of Post-acute COVID-19 Syndrome

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.

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Key information

Conditions

Post-Acute COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southwest College of Naturopathic Medicine

Tempe, Arizona, 85282, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homeopathic Medication

Drug

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.

Placebo

Other

Inert lactose pellets

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

    

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline and 12 weeks

    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.

  2. Measure Yourself Medical Outcomes Profile Symptom #1

    Time frame: Baseline and 12 weeks

    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.

  3. Measure Yourself Medical Outcomes Profile Symptom #2

    Time frame: Baseline and 12 weeks

    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.

  4. Patient Doctor Depth of Relationship (PDDR)

    Time frame: 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

Southwest College of Naturopathic Medicine

Other

Collaborators

  • Samueli Institute for Information Biology

Registry information

Official study title

Homeopathic Treatment of Post-acute COVID-19 Syndrome- A Pilot Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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