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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes COVID-19 (coronavirus disease 2019). Patients with COVID-19 may experience various clinical manifestations, from no symptoms to critical illness such as severe pneumonia and acute respiratory distress syndrome (ADRS). So far, there is no specific medication for COVID-19; hence, the current available treatments mostly aim at symptoms management and supportive care. From traditional medicine perspective, COVID-19 is classified as warm-disease (Wen-yi). The main points of treatment for COVID-19 in early stage based on traditional medicine perspective are strengthen the Protective Qi (Wei Qi - the body immune system), and restore the balance of Qi, which is vital biological energy to prevent the invasion of external pathogens, including the SARS-CoV-2 virus. The Shen Cao Gan Jiang Tang have including Gan Cao Gan Jiang Tang (GGT) with the addition of Ginseng. This formula is originated from Shang Han Lun (Treatise on Febrile Diseases Caused by Cold) by Zhang Zhong-jing, used to enhance the Protective Qi, treat the early stage of Febrile Diseases, This clinical trial aims to evaluate the efficacy of the Shen Cao Gan Jiang Tang on mild and moderate COVID-19 patients
The main objectives of this clinical trial:
This study is investigated by the following hypotheses: combining Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) with the standard of care is effective in reducing the duration and severity of symptoms, reducing the proportion of patients progressed to severe level, and reducing the length of hospital stay on mild and moderate COVID-19 patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| • Experimental: Investigational arm | Experimental | Patients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) and the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline. |
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| • Controlled arm | No Intervention | Patients receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) | Drug | Patients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng), one bag of decoction (90ml) two times a day for 10 days. In additional, patients also receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline. Ingredients per formula (tang): 12 grams of honey-fried Radix Glycyrrhizae, 6 grams of Rhizoma Zingiberis (stir-baked), 6 grams of Panax Ginseng. The decoction of concentrated extract is packed into aluminum foil vacuum bag, 90ml per bag, 1 formula (tang) is equivalent to 2 bags. Patients use the decoction directly from the bag. Daily dose: 1 bag per time, 2 times per day |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of symptoms of COVID-19 | Time (days) from randomization to symptoms disappear | From Day 1 to Day 21 after randomization |
| The severity of the COVID-19 total and individual symptoms | Time (days) from randomization to the relief of total and individual COVID-19 symptoms scores | From Day 1 to Day 21 after randomization |
| Rate of progression to disease severity | Number of patients (%) progressed to severe level of COVID-19 severity scale based on the Vietnam Ministry of Health severity scale during the period of the treatment | During inpatient treatment, maximum to Day 21 after randomization |
| The time required to meet discharge standards | Time (days) from randomization to get required for a negative real-time polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 or CT > 30 | During inpatient treatment, maximum to Day 21 after randomization |
| National Early Warning Score 2 (NEWS2) | Assessed by National Early Warning Score 2 (NEWS2) | During inpatient treatment, maximum to Day 21 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle threshold (CT) | Cycle threshold (CT) values on the COVID-19 RT-PCR test | During inpatient treatment, maximum to Day 21 after randomization |
| Duration of SARS-CoV-2 virus infection | Time (days) from randomization to negative the COVID-19 RT-PCR test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Van-Dan Nguyen, MD | University of Medicine and Pharmacy at Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City | 700000 | Vietnam |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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This is a prospective, open-label, randomized controlled trial, we recruited patients with Covid-19 from five temporary for COVID-19 treatment in Ho Chi Minh City, Viet Nam.
The protocol was designed based on the Good Clinical Practice guidelines and The Declaration of Helsinki. Number of Participants have 150 mild COVID-19 patient and 150 moderate COVID-19 patient. In each group of mild or moderate patients, we plan to randomize in a 1:1 ratio. Subjects in the investigational group will receive Shen Cao Gan Jiang Tang in addition to the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline. Subjects in the controlled group will receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline.
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An open-label study was conducted because of the urgency of major public health events
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| During inpatient treatment, maximum to Day 21 after randomization |
| Mortality rate | The number of deaths (%) caused by COVID-19 | From Day 1 to Day 21 after randomization |
| Number of participants clinically recovered | Number of patients (n) without symptoms of COVID-19 on date of discharge | From Day 1 after randomisation to Day for patients meet discharge criteria |
| Paracetamol/Ibuprofen intake | The number (n) of daily doses of paracetamol/ibuprofen consumed during inpatient | From Day 1 after randomisation to Day for patients meet discharge criteria |
| Safety evaluation | Number of patients (n) that have the side effects due to the decoction based on clinical monitoring | From Day 1 to Day 21 after randomization |