A Pilot Randomized Controlled Trial of Homeopathic Treatment for Long COVID
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Measure Your Own Medical Outcome Profile (MYMOP)
研究概览
简要总结
A small-scale test of the intervention, trial design and methods to explore the cumulative effectiveness of two commonly used prescribing strategies for patients with long COVID: Treatment A - prescribing a specific homeopathic remedy for long COVID, plus or minus Treatment B - a course of individually tailored treatment by a homeopath. Both interventions compared to usual care
详细描述
We will use Trials within cohorts (TwiCs) methodology to test the cumulative effectiveness of two homeopathic prescribing strategies: Treatment A -the effectiveness of prescribing a specific homeopathic remedy for long COVID, plus or minus Treatment B - a course of individually tailored treatment by a homeopath. We will compare Treatment A, and Treatment A + B, to no homeopathic treatment.
Up to 120 participants with confirmed long COVID will be recruited to an observational cohort (the long COVID POD). Their self-reported symptoms Measure Yourself Medical Outcome Profile (MYMOP) and Wellbeing Health Survey Questionnaire (SF-36) will be measured via on-line questionnaires using the JISC on-line platform. All eligible participants will complete questionnaires monthly for the duration of the study. After completing questionnaires twice, eligible cohort participants will be randomized into two groups: one group will be offered Treatment A. The other group will remain in the observational cohort.
After one month, the Treatment A group will be further randomized into two groups, stratified according to improvement in their self-reported symptoms (MYMOP <> 30%). One group will continue with Homeopathic treatment A. The other group will be offered Homeopathic Treatment B.
Recruitment will continue until at least 60 participants have complied with Treatment A and completed at least 4 questionnaires; and 30 of them have also complied with Treatment B.
Randomisation will be performed by the study statistician and retained on his premises. : Participants will be recruited in cohorts of 15. For each cohort, all 126,126 ways of dividing this into three groups of 5 will be examined; the arrangement which displays the least differences in age, sex distribution, duration of illness and initial symptom severity will be selected, and randomly allocated to either treatment or usual care. One group will be randomly allocated to usual care, and the remaining two merged to comprise the treatment group. For outcome analysis, all cohorts will be combined. A similar procedure will be used for the second randomisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who experienced acute COVID-19 at least 12 weeks ago
- •A medical diagnosis of long COVID (diagnosis by a healthcare professional, documentation from an NHS long COVID clinic, or equivalent formal medical verification)
- •At least one recognized long COVID symptom according to NHS criteria
- •Agreement to be contacted again and interest in participating in research.
排除标准
- •Those who have not had acute COVID-19
- •Those who have not received a medical diagnosis of long COVID
- •Those not currently experiencing symptoms (MYMOP average score 1 or less)
- •Inability to give informed consent
- •Inability to complete online forms and receive zoom calls
- •Those currently under homeopathic treatment
- •Those who have started a new medication or treatment for long COVID within the past month
- •Those suffering from life threatening conditions
结局指标
主要结局
Measure Your Own Medical Outcome Profile (MYMOP)
时间窗: monthly for 6 months
The participant chooses two symptoms that bother them the most. They also choose an activity of daily living that is limited or prevented by their problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale.
次要结局
- Wellbeing Health Survey Questionnaire (SF-36)(monthly for 6 months)
研究者
Philippa Fibert
Associate lecturer
St. Mary's University, Twickenham