Long COVID
Conditions
Keywords
fatigue, Chinese herbal medicine
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.
Interventions
Shenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.
Sponsors
Jiangzhong Pharmaceutical Co., Ltd.
Hong Kong Baptist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
A double-blinded, placebo-controlled, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years adults 2. Fulfill the long COVID diagnostic criteria by Centers for Disease Control and Prevention (CDC) 3. Chalder fatigue scale (0-11) not less than 4
Exclusion criteria
1. 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. 2. Must chronically taking medicines that may affect the study results. 3. Severe obesity (BMI not less than 45) 4. Alcoholism or drug abuse 5. Allergy to Chinese medicine 6. Pregnancy, or plan to be pregnant, or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue: Change of scores in Chalder fatigue scale (0-33 points) | 4 weeks | The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life: Change of scores in 36-Item Short Form Survey (SF-36) | 4 weeks | The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. |
| Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS) | 4 weeks | HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression |
| Muscle strength: Change of Hand Grip Strength (HGS) | 4 weeks | 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 |
| Insomnia: Change of scores in Insomnia Severity Index (ISI) | 4 weeks | The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. |
| Safety: number of adverse events | 4 weeks | Assessed by number of adverse events or side effects |
| Exploratory outcome: Immunology analysis | 4 weeks | Assessed by the change of important immune index in serumImmune index |
| Exploratory outcome: Gut microbiota analysis | 4 weeks | Assessed by the change of gut microbiota composition and its metabolimics. |
| Long Covid related symptoms | 4 weeks | Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection. |
Countries
China
Outcome results
None listed