To Evaluate the Efficacy and Safety of "Rongyang Zhengyifang" Tea Bag With COVID-19 Variant Virus

NCT ID: NCT05504447

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2024-06-01

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.

Conditions

Herbal Interaction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Rong-Yang Zhengyifang" tea bag

1. 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, use a household 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 to be mild. Those who were diagnosed with severe disease and who did not use antiviral drugs were given tea immediately.

2. Exclusion criteria:

(1)Patient characteristics: excluded under 20 years of age, incapacity, pregnancy or lactation women (2)Disease characteristics: Western medicine has clearly diagnosed mental diseases (3)Environmental characteristics: Other conditions that prevent the patient from cooperating. If you feel unwell after screening not to sign the subject's consent form, etc.

Group Type: EXPERIMENTAL

Rong-Yang Zhengyifang" tea bag

Intervention Type: OTHER

One tea bag is 4 grams, 3 bags per day, for a total of 7 days

placebo tea bag

The appearance is exactly the same as the Zhengyifang tea bag, and the ingredient is oolong tea

Group Type: PLACEBO_COMPARATOR

placebo tea bag

Intervention Type: OTHER

One tea bag is 4 grams, 3 bags per day, for a total of 7 days

Interventions

Rong-Yang Zhengyifang" tea bag

One tea bag is 4 grams, 3 bags per day, for a total of 7 days

Intervention Type: OTHER

placebo tea bag

One tea bag is 4 grams, 3 bags per day, for a total of 7 days

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yen-Ying Kung, doctor

Role: STUDY_CHAIR

TaipeiVGH Center for Traditional Medicine

Locations

Center for Traditional Medicine, Taipei Veterans General Hospital

Taipei County, , Taiwan

Countries

Taiwan

Other Identifiers

2022-06-007B

Identifier Type: -

Identifier Source: org_study_id