Homeopathic Treatment of Post-acute COVID-19 Syndrome- A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Fatigue Assessment Scale (FAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both study medication and placebo are identical in appearance, odor, and taste. Statistician will be blinded as to treatment group.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •A fatigue score above 21 in the Fatigue Assessment Scale upon enrollment
- •Willing to fill out regular questionnaires
- •Willing to use homeopathic medicines
排除标准
- •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
研究组 & 干预措施
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
干预措施: Homeopathic Medication (Drug)
Placebo Group
Identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines.
干预措施: Placebo (Other)
结局指标
主要结局
Fatigue Assessment Scale (FAS)
时间窗: Baseline, 4, 8 and 12 weeks
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).
SF-36 Physical Composite Score (PCS)
时间窗: Baseline and 4, 8, and 12 weeks
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.
SF-36 Mental Composite Score (MCS)
时间窗: Baseline and 4, 8, and 12 weeks
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. 
次要结局
- 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)
研究者
Elizabeth Rice
Associate Professor Interim Dept Chair Homeopathy and Pharmacology
Southwest College of Naturopathic Medicine