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Efficacy Evaluation of Shen Cao Gan Jiang Tang on Mild and Moderate COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT05055427
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
NGUYEN VAN DAN, University of Medicine and Pharmacy at Ho Chi Minh City

Brief Summary:
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

Condition or disease Intervention/treatment Phase
COVID-19 Respiratory Infection Herbal Medicine Drug: Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) Phase 2 Phase 3

Detailed Description:

The main objectives of this clinical trial:

  1. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing duration and severity of symptoms compared with the standard of care in mild and moderate COVID-19 patients.
  2. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing the proportion of patients progressed to severe level compared with the standard of care in mild and moderate COVID-19 patients.
  3. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing the time required to meet discharge standards compared with the standard of care in mild and moderate COVID-19 patients.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Masking Description: An open-label study was conducted because of the urgency of major public health events
Primary Purpose: Treatment
Official Title: Efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang With Ginseng) on Mild and Moderate COVID-19 Patients: A Multicenter, Prospective, Randomized Controlled Trial
Actual Study Start Date : August 20, 2021
Estimated Primary Completion Date : March 20, 2022
Estimated Study Completion Date : August 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: • Experimental: Investigational arm
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.
Drug: Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)

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

Other Name: "Sâm Thảo Can khương thang (Cam thảo Can khương gia Nhân sâm)"

No Intervention: • Controlled arm
Patients receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline



Primary Outcome Measures :
  1. Duration of symptoms of COVID-19 [ Time Frame: From Day 1 to Day 21 after randomization ]
    Time (days) from randomization to symptoms disappear

  2. The severity of the COVID-19 total and individual symptoms [ Time Frame: From Day 1 to Day 21 after randomization ]
    Time (days) from randomization to the relief of total and individual COVID-19 symptoms scores

  3. Rate of progression to disease severity [ Time Frame: During inpatient treatment, maximum to Day 21 after randomization ]
    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

  4. The time required to meet discharge standards [ Time Frame: During inpatient treatment, maximum to Day 21 after randomization ]
    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

  5. National Early Warning Score 2 (NEWS2) [ Time Frame: During inpatient treatment, maximum to Day 21 after randomization ]
    Assessed by National Early Warning Score 2 (NEWS2)


Secondary Outcome Measures :
  1. Cycle threshold (CT) [ Time Frame: During inpatient treatment, maximum to Day 21 after randomization ]
    Cycle threshold (CT) values on the COVID-19 RT-PCR test

  2. Duration of SARS-CoV-2 virus infection [ Time Frame: During inpatient treatment, maximum to Day 21 after randomization ]
    Time (days) from randomization to negative the COVID-19 RT-PCR test

  3. Mortality rate [ Time Frame: From Day 1 to Day 21 after randomization ]
    The number of deaths (%) caused by COVID-19

  4. Number of participants clinically recovered [ Time Frame: From Day 1 after randomisation to Day for patients meet discharge criteria ]
    Number of patients (n) without symptoms of COVID-19 on date of discharge

  5. Paracetamol/Ibuprofen intake [ Time Frame: From Day 1 after randomisation to Day for patients meet discharge criteria ]
    The number (n) of daily doses of paracetamol/ibuprofen consumed during inpatient

  6. Safety evaluation [ Time Frame: From Day 1 to Day 21 after randomization ]
    Number of patients (n) that have the side effects due to the decoction based on clinical monitoring



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • From full 18 to 64 years old;
  • The patient was diagnosed with SARS-CoV-2 infection by RT-PCR confirmation (+) and CT < 30.
  • Patients classified as mild (acute upper respiratory tract infection): patients infected with SARS-CoV-2 early in the first 5 days from the time of having one of the non-specific clinical symptoms such as fever, cough dry, sore throat, stuffy nose, fatigue, headache, muscle pain, decreased taste, decreased sense of smell. And there are no signs of pneumonia or hypoxia, respiratory rate ≤ 20 times/min, Saturation of Peripheral Oxygen (SpO2) ≥ 96% when breathing air.
  • Patients classified as moderate (Pneumonia): patients infected with SARS-CoV-2 in the first 10 days from the time of having one of the non-specific clinical symptoms, showing signs of pneumonia (fever, cough, dyspnea, tachypnea >20 breaths/min) and no signs of severe pneumonia, Saturation of Peripheral Oxygen (SpO2) ≥ 93% when breathing air.
  • Inpatient treatment
  • Subjects do not use any other medicines with herbal ingredients for underlying conditions or any other purposes;
  • Voluntary participation in the study by signing an informed consent
  • Patients who have not been vaccinated or have just received 1 dose of COVID-19 vaccine

Exclusion Criteria:

  • Severe or critical COVID-19 based on the COVID-19 severity scale of Vietnam Ministry of Health;
  • Chronic obstructive pulmonary disease, kidney failure requiring dialysis or creatinine ≥ 2.0mg/dl through medical history; parenteral or parenteral nutrition, uncontrolled type 2 diabetes (HbA1c > 7%), uncontrolled hypertension (value > 160/100 mmHg), uncontrolled coronary artery disease (new/currently established) requires medication adjustment), heart failure, neurological disease (eg, acute stroke, polyneuritis within 1 month) or mental illness, active tuberculosis, active autoimmune disease;
  • Have a chronically weakened immune system (AIDS, cancer, undergoing chemotherapy-radiotherapy in the past six months, immunosuppressive disease);
  • Taking immunosuppressive drugs (e.g., anti-rejection treatment after organ transplant or blood stem cell transplant);
  • Allergic to products that contain ginseng;
  • Pregnant or lactating women;
  • Already participating in another clinical trial;
  • The patient has received 2 doses of COVID-19 vaccine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05055427


Contacts
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Contact: Van-Dan Nguyen, MD +84983731326 nguyenvandan@ump.edu.vn

Locations
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Vietnam
University of Medicine and Pharmacy at Ho Chi Minh City Recruiting
Ho Chi Minh, Vietnam, 700000
Contact: Dieu-Thuong Trinh Thi, PhD    +84933000880    thuong.ttd@ump.edu.vn   
Contact: Van-Dan Nguyen, MD    +84983731326    nguyenvandan@ump.edu.vn   
Principal Investigator: Dieu-Thuong Trinh Thi, PhD         
Principal Investigator: Van-Dan Nguyen, MD         
Sponsors and Collaborators
University of Medicine and Pharmacy at Ho Chi Minh City
Investigators
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Principal Investigator: Van-Dan Nguyen, MD University of Medicine and Pharmacy at Ho Chi Minh City
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Responsible Party: NGUYEN VAN DAN, Principal Investigator, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier: NCT05055427    
Other Study ID Numbers: 458/HĐĐĐ-ĐHYD
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases