Homeopathic Treatment of Post-acute COVID-19 Syndrome

NCT ID: NCT05104749

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-04-22

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.

Conditions

Post-acute Covid-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Homeopathic Treatment Group

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

Group Type: EXPERIMENTAL

Homeopathic Medication

Intervention Type: 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 Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Inert lactose pellets

Interventions

Homeopathic Medication

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: DRUG

Placebo

Inert lactose pellets

Intervention Type: OTHER

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samueli Institute for Information Biology

OTHER

Sponsor Role: collaborator

Southwest College of Naturopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Rice

Associate Professor Interim Dept Chair Homeopathy and Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Rice, ND

Role: PRINCIPAL_INVESTIGATOR

Southwest College of Naturopathic Medicine

Locations

Southwest College of Naturopathic Medicine

Tempe, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0012021

Identifier Type: -

Identifier Source: org_study_id