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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
77
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.
Inert lactose pellets
Southwest College of Naturopathic Medicine
Tempe, Arizona, United States
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).
Time frame: 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.
Time frame: 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. 
Time frame: Baseline and 4, 8, and 12 weeks
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 12 weeks