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

To Evaluate the Efficacy and Safety of Rongyang Zhengyifang Tea Bag in Mildly Diagnosed Patients With COVID-19 Variant Virus

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05504447
Enrollment
92
Registered
2022-08-17
Start date
2022-08-15
Completion date
2024-06-01
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herbal Interaction

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.

Interventions

OTHERRong-Yang Zhengyifang tea bag

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

OTHERplacebo tea bag

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

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

1. Parallel study design. 2. There is a control group (placebo). 3. Blinding method: non-blind. 4. Random assignment: yes

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire Evaluation7daysThe questionnaire contains a total of 28 assessment items: Divided into 7 major aspects: nasal symptoms (6 questions), eye symptoms (2 questions), Sleep condition (4 questions), ear symptoms (5 questions), overall symptoms (7 questions), daily life Influence (4 questions) and the influence of emotions (3 questions). According to the patient's 7 days,the symptoms within are scored for each item, and the first category is to evaluate the symptoms of this item. The first score ranges from 0 points (no such symptoms) to 5 points (extremely severe Heavy); The second category is to assess the importance of this symptom to the patient, starting from 1 Points (not important) to 4 points (very important). Multiply these two fractions together to get the symptom-impact score , this is the individual evaluation score of each patient for each symptom.

Secondary

MeasureTime frameDescription
Rapid screening reagent screening7daysComparison of the number of days from a positive diagnosis of rapid screening to a negative test

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026