Clinical trial NCT05104749: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-acute Covid-19 Syndrome
Keywords: Long Covid
Lead sponsor: Southwest College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Samueli Institute for Information Biology
First posted: 2021-11-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fatigue Assessment Scale (FAS)
timeFrame: Baseline, 4, 8 and 12 weeks
measure: SF-36 Physical Composite Score (PCS)
timeFrame: Baseline and 4, 8, and 12 weeks
measure: SF-36 Mental Composite Score (MCS)
timeFrame: Baseline and 4, 8, and 12 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 12 weeks
measure: Measure Yourself Medical Outcomes Profile Symptom #1
timeFrame: Baseline and 12 weeks
measure: Measure Yourself Medical Outcomes Profile Symptom #2
timeFrame: Baseline and 12 weeks
measure: Patient Doctor Depth of Relationship (PDDR)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Southwest College of Naturopathic Medicine
state: Arizona
Study officials:
affiliation: Southwest College of Naturopathic Medicine
name: Elizabeth Rice, ND
role: PRINCIPAL_INVESTIGATOR
References: