Clinical trial NCT05504447: To Evaluate the Efficacy and Safety of "Rongyang Zhengyifang" Tea Bag With COVID-19 Variant Virus
Official title: To Evaluate the Efficacy and Safety of "Rongyang Zhengyifang" Tea Bag in Mildly Diagnosed Patients With COVID-19 Variant Virus
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Herbal Interaction
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-08-17
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Parallel study design.
2. There is a control group (placebo).
3. Blinding method: non-blind.
4. Random assignment: yes
Primary purpose: PREVENTION

Brief summary: The strategy of our study is to use traditional Chinese medicine tea to regulate physical fitness and strength can be enhanced to help patients with mildly diagnosed COVID-19 variant virus to achieve self-recovery ability and avoid the development of moderate and severe symptoms.

Detailed description: According to the "Interim Guidelines for the Clinical Treatment of Novel Coronavirus SARS-CoV-2 Infection" published by the CDC of the Ministry of Health and Welfare on June 23, 2021, it can be classified into mild, moderate, severe and extremely severe according to the classification of its related clinical manifestations.

Current clinical studies have found that COVID-19 primarily attacks the bronchioles and alveoli of the lower respiratory tract. In severe cases, it may induce an inflammatory response, leading to pulmonary airway and alveolar damage, and even pulmonary fibrosis.

The strategy of our study is to use traditional Chinese medicine tea to regulate physical fitness and strength can be enhanced to help patients with mildly diagnosed COVID-19 variant virus to achieve self-recovery ability and avoid the development of moderate and severe symptoms.It may reduce the expenditure of health insurance and medical expenses, and more importantly, if it can be administered timely to block the progression of the disease when mild-to-moderate symptoms occur, it can also reduce the burden of hospital medical care.

Eligibility criteria: Inclusion Criteria:

* Aged over 20 years old, according to the guidelines of the Epidemic Command Center, during home isolation and self-epidemic prevention or home quarantine period, use the home novel coronavirus antigen rapid screening reagent to test positive, and after the medical staff confirms the relevant symptoms or the PCR test is positive, it is determined as Those who were mildly diagnosed and who did not use antiviral drugs were given tea immediately.

Exclusion Criteria:

* Patient characteristics: Exclude women under the age of 20, incapacitated, pregnant or breastfeeding
* Disease characteristics: subjects who have been diagnosed with mental illness by Western medicine, and who have long-term diarrhea or long-term use of traditional Chinese medicine
* Environmental characteristics: other conditions that prevent the patient from cooperating. Such as being unsuitable after screening, not signing the subject's consent form, etc.

Primary outcomes:
measure: Questionnaire Evaluation
timeFrame: 7days
Secondary outcomes:
measure: Rapid screening reagent screening
timeFrame: 7days
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Center for Traditional Medicine, Taipei Veterans General Hospital
Study officials:
affiliation: TaipeiVGH Center for Traditional Medicine
name: Yen-Ying Kung, doctor
role: STUDY_CHAIR
References: