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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05228873
• Other study ID #: 838-9/HÐÐÐ-ÐHYD
• Status: Completed
• Start date: December 20, 2021
• Est. completion date: January 20, 2023

Study information

• Verified date: July 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Vietnam	University of Medicine and Pharmacy at Ho Chi Minh City	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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