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

NCT05228873 | Completed

• 1 other identifier: 838-9/HĐĐĐ-ĐHYD
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Pandemic; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post COVID-19 symptoms

  3 months

Study Arms (2)

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)

• 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

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. 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.

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

Investigational arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

COVID-19

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nguyen Van Dan

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 8, 2022
• Study Start: December 20, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

VN (1)