ISRCTN12368131进行中（未招募）3 期
Clinical trial of Ashwagandha for promoting recovery from COVID-19 in the UK
ondon School of Hygiene & Tropical Medicine0 个研究点目标入组 2,500 人开始时间: 2022年8月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults (18 years or older) with the capacity to provide informed consent, and
- •2. Have been diagnosed with Long COVID as per the NICE Guidelines (NG188) – that is, either one of Ongoing symptomatic COVID-19; signs and symptoms of COVID-19 from 4 weeks up to 12 weeks”, or Post-COVID-19 syndrome; Signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis. It usually presents with clusters of symptoms, often overlapping, which can fluctuate and change over time and can affect any system in the body. Post-COVID-19 syndrome may be considered before 12 weeks while the possibility of an alternative underlying disease is also being assessed”. The diagnosis will be confirmed by the participant’s GP and/or
- •3. medical records.
- •4. Report that their Long COVID has reduced their ability to carry out day-to-day activities compared with the time before they had COVID-19.
- •5. Willing and able to complete the study protocols (take trial medication regularly for 3 months, complete online telephone or postal surveys monthly, and participate in clinical monitoring assessment monthly)
- •6. Not taking any other herbal medicines, or willing to stop taking any such medicines for the duration of the trial. Herbal medicine is defined as a plant or plant part, or mixture or extract of these, which is taken in medicinal form to improve health, prevent disease, or treat illness
排除标准
- •1. Self-diagnosed Long COVID in the absence of a clinical diagnosis as per the NICE Guidelines
- •2. Any medical condition or suspected medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study (this may involve conduct of any clinical assessment deemed necessary by the study investigator to confirm that this criterion is met, such as (but not limited to) validated psychiatric scales, ECGs, and laboratory tests for clinical chemistry, haematology, urinalysis, kidney function, etc).
- •3. Previous clinical diagnosis of severe psychiatric disorders
- •4. Abnormal liver function test results, as indicated by alanine aminotransferase or aspartate aminotransferase or total bilirubin >2 x ULN, either measured as part of routine care within past 3 months or conducted for the purposes of the clinical trial (if a recent test result is not available).
- •5. Previous clinical diagnosis of chronic kidney disease or other medical condition associated with impaired kidney function
- •6. Previous clinical diagnosis of heart disease or other cardiac problems
- •7. Use of any investigational products within 5 elimination half-lives after the last dose or at screening
- •8. History of malignancy unless resolved by adequate treatment with no evidence of recurrence
- •9. Hypersensitivity to the active substance or to any of the excipients
- •10. Women breastfeeding or with a positive urine pregnancy test at screening
- •11. Women planning to become pregnant for the duration of the participation in the study
- •12. Men and women of childbearing potential unwilling to adhere to the relevant contraception requirements for the duration of the study (until at least 24 hours after the final dose of trial medication is taken). Women of childbearing potential (WOCBP) are defined as all women who are: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.” Acceptable contraception methods for WOCBP in this trial include: combined hormonal contraception, progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence, or condom use. Sexual abstinence is defined as: refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject”. Male participants are required to use condoms. All participants are required to inform investigator immediately if these contraception requirements are not met or if pregnancy is suspected.
- •13. Participants taking benzodiazepines, anticonvulsants, barbiturates or any other CNS depressants
研究者
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