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

NCT ID: NCT05228873

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2023-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Pandemic Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Intervention Type 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.

• 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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sâm Thảo Can khương thang (Cam thảo Can khương thang gia Nhân sâm) - Vietnamese name

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NGUYEN VAN DAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nguyen Van Dan

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy at Ho Chi Minh City

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Vietnam

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

838-9/HĐĐĐ-ĐHYD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.