The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated Fatigue

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Long COVID

Intervention / Treatment
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* Drug: Shenlingcao Oral Liquid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blinded, placebo-controlled, randomized clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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. | Drug: Shenlingcao Oral Liquid<br>* Shenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.<br>* Other names: placebo of Shenlingcao Oral Liquid;|
| Placebo Comparator: Control group<br>Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks. | Drug: Shenlingcao Oral Liquid<br>* Shenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.<br>* Other names: placebo of Shenlingcao Oral Liquid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue: 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 4 weeks | 
| Long Covid related symptoms | Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection. | 4 weeks | 
| Safety: number of adverse events | Assessed by number of adverse events or side effects | 4 weeks | 
| Exploratory outcome: Immunology analysis | Assessed by the change of important immune index in serumImmune index | 4 weeks | 
| Exploratory outcome: Gut microbiota analysis | Assessed by the change of gut microbiota composition and its metabolimics. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, Chinese herbal medicine