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Homeopathic Treatment of Post-acute COVID-19 Syndrome

Primary Purpose

Post-acute Covid-19 Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Homeopathic Medication
Placebo
Sponsored by
Southwest College of Naturopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-acute Covid-19 Syndrome focused on measuring Long Covid

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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
  • Full Covid-19 vaccination; i.e. 2 weeks after a two-dose series (Pfizer or Moderna) or 2 weeks after a single-dose vaccine (Johnson & Johnson)
  • 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
    • Partial Covid vaccination or unvaccinated 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

Sites / Locations

  • Southwest College of Naturopathic Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Homeopathic Treatment Group

Placebo Group

Arm 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

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

Outcomes

Primary Outcome Measures

Fatigue Assessment Scale (FAS)
General fatigue questionnaire to assess fatigue. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Change in Fatigue Assessment Scale (FAS)
General fatigue questionnaire to assess fatigue. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
36 Item Short Form Survey (SF 36)
Quality of life measure
Change in 36 Item Short Form Survey (SF 36)
Quality of life measure

Secondary Outcome Measures

Measure Yourself Medical Outcomes Profile (MYMOP)
Patient specific outcome tool to assess general health
Measure Yourself Medical Outcomes Profile (MYMOP)
Patient specific outcome tool to assess general health

Full Information

First Posted
October 28, 2021
Last Updated
March 13, 2023
Sponsor
Southwest College of Naturopathic Medicine
Collaborators
Samueli Institute for Information Biology
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1. Study Identification

Unique Protocol Identification Number
NCT05104749
Brief Title
Homeopathic Treatment of Post-acute COVID-19 Syndrome
Official Title
Homeopathic Treatment of Post-acute COVID-19 Syndrome- A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest College of Naturopathic Medicine
Collaborators
Samueli Institute for Information Biology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-acute Covid-19 Syndrome
Keywords
Long Covid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Both study medication and placebo are identical in appearance, odor, and taste. Statistician will be blinded as to treatment group.
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Homeopathic Treatment Group
Arm Type
Experimental
Arm 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
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines.
Intervention Type
Drug
Intervention Name(s)
Homeopathic Medication
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inert lactose pellets
Primary Outcome Measure Information:
Title
Fatigue Assessment Scale (FAS)
Description
General fatigue questionnaire to assess fatigue. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Time Frame
Baseline
Title
Change in Fatigue Assessment Scale (FAS)
Description
General fatigue questionnaire to assess fatigue. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Time Frame
4, 8, and 12 weeks
Title
36 Item Short Form Survey (SF 36)
Description
Quality of life measure
Time Frame
Baseline
Title
Change in 36 Item Short Form Survey (SF 36)
Description
Quality of life measure
Time Frame
4, 8, and 12 weeks
Secondary Outcome Measure Information:
Title
Measure Yourself Medical Outcomes Profile (MYMOP)
Description
Patient specific outcome tool to assess general health
Time Frame
Baseline
Title
Measure Yourself Medical Outcomes Profile (MYMOP)
Description
Patient specific outcome tool to assess general health
Time Frame
12 weeks or at withdrawl

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Full Covid-19 vaccination; i.e. 2 weeks after a two-dose series (Pfizer or Moderna) or 2 weeks after a single-dose vaccine (Johnson & Johnson) 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 Partial Covid vaccination or unvaccinated 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Rice, ND
Organizational Affiliation
Southwest College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest College of Naturopathic Medicine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Homeopathic Treatment of Post-acute COVID-19 Syndrome

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