Homeopathic Treatment of Post-acute COVID-19 Syndrome

NCT05104749 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 0012021
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-acute Covid-19 Syndrome

Keywords

Long Covid

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline and 12 weeks

• Measure Yourself Medical Outcomes Profile Symptom #1

  Baseline and 12 weeks

• Measure Yourself Medical Outcomes Profile Symptom #2

  Baseline and 12 weeks

• Patient Doctor Depth of Relationship (PDDR)

  12 weeks

Study Arms (2)

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

Drug: Homeopathic Medication

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

Homeopathic Treatment Group

Placebo OTHER

Inert lactose pellets

Placebo Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest College of Naturopathic Medicine: lead
• Samueli Institute for Information Biology: collaborator

Study Sites (1)

Southwest College of Naturopathic Medicine

Tempe, Arizona, 85282, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Elizabeth Rice Principal Investigator
• Organization: Sonoran University of Health Sciences

e.rice@sonoran.edu

4809700000

Study Officials

• Elizabeth Rice, ND

  Southwest College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both study medication and placebo are identical in appearance, odor, and taste. Statistician will be blinded as to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Interim Dept Chair Homeopathy and Pharmacology

Model Details: Randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 3, 2021
• Study Start: September 15, 2021
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)