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Outcome Measures

Primary Outcomes (5)

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

Secondary Outcomes (6)

Cycle threshold (CT)
During inpatient treatment, maximum to Day 21 after randomization
Duration of SARS-CoV-2 virus infection
During inpatient treatment, maximum to Day 21 after randomization
Mortality rate
From Day 1 to Day 21 after randomization
Number of participants clinically recovered
From Day 1 after randomisation to Day for patients meet discharge criteria
Paracetamol/Ibuprofen intake
From Day 1 after randomisation to Day for patients meet discharge criteria
+1 more secondary outcomes

Study Arms (2)

• 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.

Drug: Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)

• 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

Interventions

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

Also known as: "Sâm Thảo Can khương thang (Cam thảo Can khương gia Nhân sâm)"

• Experimental: Investigational arm

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Study Design

Study Type

interventional

Phase

phase 2 3

Allocation

RANDOMIZED

Masking

NONE

Masking Details

An open-label study was conducted because of the urgency of major public health events

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (6)

Study Arms (2)

• Experimental: Investigational arm

• Controlled arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

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Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (6)

Study Arms (2)

• Experimental: Investigational arm

• Controlled arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations