Comparison of Quality of Life After Discharge of the Mild and Moderate COVID-19 Patients With or Without Herbal Medicine

Comparison of Quality of Life 3 Months After Discharge of the Mild and Moderate COVID-19 Patients With or Without Herbal Medicine (Shen Cao Gan Jiang Tang) in the Acute Stage

The purpose of this study is to see how the acute stage COVID-19 treatments by use of herbal medicine (Shen Cao Gan Jiang Tang) affect quality of life and symptoms at 3 months after hospital discharge.

Study Overview

• Status: Completed
• Conditions: Quality of Life; COVID-19 Pandemic
• Intervention / Treatment: Drug: Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)

Detailed Description

According to the theory of Traditional medicine, the patient will suffer damage to Qi and Fluid in the acute phase and lead to damaged Yin and Qi in the post COVID-19 period.

The Shen Cao Gan Jiang Tang has the effect of enhance the Protective Qi, generating Fluid, is applied to treat the mild and moderate COVID-19 in the acute phase in some hospitals in Ho Chi Minh City, Viet Nam. The hypothesis is that with the use of the Shen Cao Gan Jiang Tang, the Qi and Yin will reduce the damage, so that the patient has a better quality of life and fewer post COVID-19 symptoms compared with the standard of care group

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh, Vietnam, 700000
    • University of Medicine and Pharmacy at Ho Chi Minh City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The mild and moderate COVID-19 patients who used the Shen Cao Gan Jiang Tang in the acute phase

Description

Inclusion Criteria:

• Patients able to understand and fill out a questionnaire
• From full 18 to 64 years old;
• Patients with the mild and moderate COVID-19 who used Shen Cao Gan Jiang Tang in the acute phase for intervention group.
• Participants enrolled in protocol NCT05055427.
• Voluntarily consented to participate in the study

Exclusion Criteria:

• Patient who are not able to complete 100% of the questionnaire Criteria for stopping the study
• The patient cannot be contacted after 04 calls, each call is at least 06 hours apart on the survey days.
• The patient does not want to continue participating in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Investigational arm; 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 plus the Standard of Care (SOC) for the treatment of COVID-19 acute stage based on the Vietnam Ministry of Health guideline at this time	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. 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.; Other Names: Sâm Thảo Can khương thang (Cam thảo Can khương thang gia Nhân sâm) - Vietnamese name
• Controlled arm; Patient who receive the Standard of Care (SOC) for the treatment of COVID-19 acute stage based on the Vietnam Ministry of Health guideline at this time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QoL) questionnaire	Data will be collected by using the 36-Item Short Form Survey (SF-36) QoL instruments at 3 months after hospital discharge.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post COVID-19 symptoms	Number of patients (%) have the post COVID-19 symptoms at 3 months after hospital discharge. The post COVID-19 symptoms have included cough, shortness of breath, fatigue, headache, attention disorder, hair loss, loss of smell, loss of taste, rapid breathing after activity, joint pain	3 months

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Investigators: Principal Investigator: Nguyen Van Dan, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 838-9/HĐĐĐ-ĐHYD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No