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NCT Number: NCT05228873

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Quality of Life (QoL) questionnaire

    Time frame: 3 months

    Data will be collected by using the 36-Item Short Form Survey (SF-36) QoL instruments at 3 months after hospital discharge.

Secondary outcomes

  1. Post COVID-19 symptoms

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2022
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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