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

NCT05504447 | Unknown DMC

• 1 other identifier: 2022-06-007B
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Herbal Interaction

Outcome Measures

Primary Outcomes (1)

• Questionnaire Evaluation

  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

Secondary Outcomes (1)

• Rapid screening reagent screening

  7days

Study Arms (2)

Rong-Yang Zhengyifang" tea bag

EXPERIMENTAL

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.

Other: Rong-Yang Zhengyifang" tea bag

placebo tea bag

PLACEBO COMPARATOR

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

Other: placebo tea bag

Interventions

Rong-Yang Zhengyifang" tea bag OTHER

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

Rong-Yang Zhengyifang" tea bag

placebo tea bag OTHER

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

placebo tea bag

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Center for Traditional Medicine, Taipei Veterans General Hospital

Taipei County, 112, Taiwan

Location

Study Officials

• Yen-Ying Kung, doctor

  TaipeiVGH Center for Traditional Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: August 15, 2022
• Primary Completion: February 28, 2023
• Study Completion: June 1, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

TW (1)