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

Primary Purpose

COVID-19 Respiratory Infection, Herbal Medicine

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Respiratory Infection

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Medicine and Pharmacy at Ho Chi Minh City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

• Experimental: Investigational arm

• Controlled arm

Arm Description

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.

Patients receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline

Outcomes

Primary Outcome Measures

Duration of symptoms of COVID-19
Time (days) from randomization to symptoms disappear
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
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
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
National Early Warning Score 2 (NEWS2)
Assessed by National Early Warning Score 2 (NEWS2)

Secondary Outcome Measures

Cycle threshold (CT)
Cycle threshold (CT) values on the COVID-19 RT-PCR test
Duration of SARS-CoV-2 virus infection
Time (days) from randomization to negative the COVID-19 RT-PCR test
Mortality rate
The number of deaths (%) caused by COVID-19
Number of participants clinically recovered
Number of patients (n) without symptoms of COVID-19 on date of discharge
Paracetamol/Ibuprofen intake
The number (n) of daily doses of paracetamol/ibuprofen consumed during inpatient
Safety evaluation
Number of patients (n) that have the side effects due to the decoction based on clinical monitoring

Full Information

First Posted
September 21, 2021
Last Updated
May 28, 2023
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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1. Study Identification

Unique Protocol Identification Number
NCT05055427
Brief Title
Efficacy Evaluation of Shen Cao Gan Jiang Tang on Mild and Moderate COVID-19 Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
December 25, 2021 (Actual)
Study Completion Date
December 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
The main objectives of this clinical trial: 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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection, Herbal Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
• Experimental: Investigational arm
Arm Type
Experimental
Arm Description
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.
Arm Title
• Controlled arm
Arm Type
No Intervention
Arm Description
Patients receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline
Intervention Type
Drug
Intervention Name(s)
Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)
Other Intervention Name(s)
"Sâm Thảo Can khương thang (Cam thảo Can khương gia Nhân sâm)"
Intervention Description
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
Primary Outcome Measure Information:
Title
Duration of symptoms of COVID-19
Description
Time (days) from randomization to symptoms disappear
Time Frame
From Day 1 to Day 21 after randomization
Title
The severity of the COVID-19 total and individual symptoms
Description
Time (days) from randomization to the relief of total and individual COVID-19 symptoms scores
Time Frame
From Day 1 to Day 21 after randomization
Title
Rate of progression to disease severity
Description
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
Time Frame
During inpatient treatment, maximum to Day 21 after randomization
Title
The time required to meet discharge standards
Description
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
Time Frame
During inpatient treatment, maximum to Day 21 after randomization
Title
National Early Warning Score 2 (NEWS2)
Description
Assessed by National Early Warning Score 2 (NEWS2)
Time Frame
During inpatient treatment, maximum to Day 21 after randomization
Secondary Outcome Measure Information:
Title
Cycle threshold (CT)
Description
Cycle threshold (CT) values on the COVID-19 RT-PCR test
Time Frame
During inpatient treatment, maximum to Day 21 after randomization
Title
Duration of SARS-CoV-2 virus infection
Description
Time (days) from randomization to negative the COVID-19 RT-PCR test
Time Frame
During inpatient treatment, maximum to Day 21 after randomization
Title
Mortality rate
Description
The number of deaths (%) caused by COVID-19
Time Frame
From Day 1 to Day 21 after randomization
Title
Number of participants clinically recovered
Description
Number of patients (n) without symptoms of COVID-19 on date of discharge
Time Frame
From Day 1 after randomisation to Day for patients meet discharge criteria
Title
Paracetamol/Ibuprofen intake
Description
The number (n) of daily doses of paracetamol/ibuprofen consumed during inpatient
Time Frame
From Day 1 after randomisation to Day for patients meet discharge criteria
Title
Safety evaluation
Description
Number of patients (n) that have the side effects due to the decoction based on clinical monitoring
Time Frame
From Day 1 to Day 21 after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Van-Dan Nguyen, MD
Organizational Affiliation
University of Medicine and Pharmacy at Ho Chi Minh City
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine and Pharmacy at Ho Chi Minh City
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No

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

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