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
Overview
- Phase
- Phase 2
- Intervention
- Shenlingcao Oral Liquid
- Conditions
- Long COVID
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
ZhaoXiang Bian
Professor
Hong Kong Baptist University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Shenlingcao Oral Liquid
Control group
Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks.
Intervention: Shenlingcao Oral Liquid
Outcomes
Primary Outcomes
Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
Time Frame: 4 weeks
The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.
Secondary Outcomes
- 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)