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临床试验/NCT05228873
NCT05228873已完成不适用

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

University of Medicine and Pharmacy at Ho Chi Minh City1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Quality of Life (QoL) questionnaire

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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 NCT
  • Voluntarily consented to participate in the study

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) (Drug)

结局指标

主要结局

Quality of Life (QoL) questionnaire

时间窗: 3 months

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

次要结局

  • Post COVID-19 symptoms(3 months)

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

NGUYEN VAN DAN

Principal Investigator

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (1)

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