The Efficacy and Safety of a Chinese Herbal Medicine (Shenlingcao Oral Liquid) for Treating Long COVID Associated Fatigue：a Double-blinded, Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue.
详细描述
This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue. Our target population is adults (18-65 years old) with a COVID-19 infection history and have moderate to severe fatigue symptom at least 4 weeks after infection. The total sample size is 152. All participants will be randomly attributed to treatment group or placebo group in 1:1 ratio. The treatment duration is 4-week, and the follow-up period is also 4 weeks. Shenlingcao oral solution has been registered and marketed in mainland China, it is a safe product and pervious studies suggested it has anti-fatigue function. The primary efficacy outcome is the change of scores of Chalder fatigue scale (0-33 points) after 4-week treatment. The primary safety outcome is the number of adverse events. This study will be conducted in Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years adults
- •Fulfill the long COVID diagnostic criteria by Centers for Disease Control and Prevention (CDC)
- •Chalder fatigue scale (0-11) not less than 4
排除标准
- •Have any medical history that may cause fatigue before COVID-19 infection, which include but not limited to cardiovascular diseases, chronic lung diseases, dyspnea, cognitive diseases, psychological diseases, chronic liver or renal diseases, cancer, etc.
- •Must chronically taking medicines that may affect the study results.
- •Severe obesity (BMI not less than 45)
- •Alcoholism or drug abuse
- •Allergy to Chinese medicine
- •Pregnancy, or plan to be pregnant, or lactating women
研究组 & 干预措施
Treatment group
Subjects need to take the Chinese herbal medicine (Shenlingcao oral liquid) 200 ml twice per day for 4 weeks. Shenlingcao oral solution is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.
干预措施: Shenlingcao Oral Liquid (Drug)
Control group
Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks.
干预措施: Shenlingcao Oral Liquid (Drug)
结局指标
主要结局
Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
时间窗: 4 weeks
The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.
次要结局
- Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)(4 weeks)
- Insomnia: Change of scores in Insomnia Severity Index (ISI)(4 weeks)
- Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)(4 weeks)
- Long Covid related symptoms(4 weeks)
- Exploratory outcome: Gut microbiota analysis(4 weeks)
- Exploratory outcome: Immunology analysis(4 weeks)
- Muscle strength: Change of Hand Grip Strength (HGS)(4 weeks)
- Safety: number of adverse events(4 weeks)
研究者
ZhaoXiang Bian
Professor
Hong Kong Baptist University