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| Name | Class |
|---|---|
| Jiangzhong Pharmaceutical Co., Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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. |
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| Control group | Placebo Comparator | Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenlingcao Oral Liquid | Drug | Shenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Baptist University Chinese Medicine Clinic | Recruiting | Hong Kong | China |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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A double-blinded, placebo-controlled, randomized clinical trial
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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 |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |