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| Name | Class |
|---|---|
| Samueli Institute for Information Biology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Homeopathic Treatment Group | Experimental | 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 Group | Placebo Comparator | Identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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.  | Baseline and 4, 8, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Clinically significant kidney, heart, or hepatic impairment as determined by clinical judgment
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Rice, ND | Southwest College of Naturopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest College of Naturopathic Medicine | Tempe | Arizona | 85282 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Homeopathic Treatment Group | Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis. |
| FG001 | Placebo Group | Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants under randomization were included (intention-to-treat population).
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| ID | Title | Description |
|---|---|---|
| BG000 | Homeopathic Treatment Group | Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis. |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All patients under randomization were included (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4, 8 and 12 weeks |
|
During study duration (12 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Homeopathic Treatment Group | Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | SNOMED CT | Systematic Assessment | Elevated blood pressure reading responded to cardiologist change in medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Rice Principal Investigator | Sonoran University of Health Sciences | 4809700000 | e.rice@sonoran.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2021 | Aug 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Randomized, double-blind, placebo-controlled clinical trial
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Both study medication and placebo are identical in appearance, odor, and taste. Statistician will be blinded as to treatment group.
|
| Placebo | Other | Inert lactose pellets |
|
| 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. | 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. | 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). | 12 weeks |
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education Status | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Duration of Long Covid Symptoms | Mean | Standard Deviation | Days |
|
| Hospitalization Rate for Acute Covid-19 Infection | At baseline, all participating subjects receiving placebo or homeopathy were assessed for hospitalization during their initial COVID-19 acute infection. | Count of Participants | Participants |
|
| Number of Vaccinated Participants | At baseline, all participating subjects receiving placebo or homeopathy were assessed whether they had received a full or partial COVID-19 vaccination. | Count of Participants | Participants |
|
| Number of Long Covid Booster Participants | At baseline, all participating subjects receiving placebo or homeopathy were assessed whether they had received a COVID-19 booster vaccination. | Count of Participants | Participants |
|
| Number of Medications | Count of Participants | Participants |
|
| Number of Supplements | Count of Participants | Participants |
|
| Baseline Score in Fatigue Assessment Scale | 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). | Mean | Standard Deviation | score on a scale |
|
| Baseline Score in 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. | Mean | Standard Deviation | score on a scale |
|
| Baseline Score in SF-36 Mental Combined 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. | Mean | Standard Deviation | score on a scale |
|
| Baseline Score in 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 | Mean | Standard Deviation | score on a scale |
|
| Baseline Score in MYMOP 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. | Mean | Standard Deviation | score on a scale |
|
| Baseline Score in MYMOP 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. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Placebo Group | Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines) |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4, 8, and 12 weeks |
|
|
|
| Primary | 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.  | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4, 8, and 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 6 |
| 38 |
| EG001 | Placebo Group | Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines) | 0 | 39 | 2 | 39 | 6 | 39 |
|
| Gout | Metabolism and nutrition disorders | SNOMED CT | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | SNOMED CT | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
| Headache | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | SNOMED CT | Systematic Assessment |
|
| Vaccine Injury | Immune system disorders | SNOMED CT | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | SNOMED CT | Systematic Assessment |
|
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| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 12 Weeks |
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| Week 12 |
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