- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504447
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei county, Taiwan, 112
- Center for Traditional Medicine, Taipei Veterans General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rong-Yang Zhengyifang" tea bag
(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. |
One tea bag is 4 grams, 3 bags per day, for a total of 7 days
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Placebo Comparator: placebo tea bag
The appearance is exactly the same as the Zhengyifang tea bag, and the ingredient is oolong tea
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One tea bag is 4 grams, 3 bags per day, for a total of 7 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire Evaluation
Time Frame: 7days
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The 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. |
7days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rapid screening reagent screening
Time Frame: 7days
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Comparison of the number of days from a positive diagnosis of rapid screening to a negative test
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7days
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Collaborators and Investigators
Investigators
- Study Chair: Yen-Ying Kung, doctor, TaipeiVGH Center for Traditional Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-06-007B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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