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

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05504447
Collaborator
(none)
92
1
2
21.6
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rong-Yang Zhengyifang" tea bag
  • Other: placebo tea bag
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel study design. There is a control group (placebo). Blinding method: non-blind. Random assignment: yesParallel study design. There is a control group (placebo). Blinding method: non-blind. Random assignment: yes
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
To Evaluate the Efficacy and Safety of "Rongyang Zhengyifang" Tea Bag in Mildly Diagnosed Patients With COVID-19 Variant Virus
Actual Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rong-Yang Zhengyifang" tea bag

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. 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.

Other: Rong-Yang Zhengyifang" tea bag
One tea bag is 4 grams, 3 bags per day, for a total of 7 days

Placebo Comparator: placebo tea bag

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

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

Outcome Measures

Primary Outcome Measures

  1. Questionnaire Evaluation [72days]

    Using Partial Rhinosinusitis Symptoms (CRSOM-31), combined with the Asthma Control Questionnaire (ACQ)

Secondary Outcome Measures

  1. Rapid screening reagent screening [7days]

    Comparison of the number of days from a positive diagnosis of rapid screening to a negative test

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Traditional Medicine, Taipei Veterans General Hospital Taipei county Taiwan 112

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

  • Study Chair: Yen-Ying Kung, doctor, TaipeiVGH Center for Traditional Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT05504447
Other Study ID Numbers:
  • 2022-06-007B
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 17, 2022