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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
152
Shenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.
Hong Kong Baptist University Chinese Medicine Clinic
Hong Kong, China
RECRUITINGFatigue: Change of scores in Chalder fatigue scale (0-33 points)
The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.
Time frame: 4 weeks
Insomnia: Change of scores in Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Time frame: 4 weeks
Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health.
Time frame: 4 weeks
Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)
HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression
Time frame: 4 weeks
Muscle strength: Change of Hand Grip Strength (HGS)
Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength
Time frame: 4 weeks
Long Covid related symptoms
Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection.
Time frame: 4 weeks
Safety: number of adverse events
Assessed by number of adverse events or side effects
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Time frame: 4 weeks
Exploratory outcome: Immunology analysis
Assessed by the change of important immune index in serumImmune index
Time frame: 4 weeks
Exploratory outcome: Gut microbiota analysis
Assessed by the change of gut microbiota composition and its metabolimics.
Time frame: 4 weeks