Herbal InteractionNCT05504447
To Evaluate the Efficacy and Safety of "Rongyang Zhengyifang" Tea Bag With COVID-19 Variant Virus
A study testing Rong-Yang Zhengyifang" tea bag in people with Herbal Interaction, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herbal Interaction
- What is being tested?
- Rong-Yang Zhengyifang" tea bag
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Center for Traditional Medicine, Taipei Veterans General Hospital
Taipei County, 112
About this study
Official title: To Evaluate the Efficacy and Safety of "Rongyang Zhengyifang" Tea Bag in Mildly Diagnosed Patients With COVID-19 Variant Virus
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.
Read the 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
- Being tested
- Rong-Yang Zhengyifang" tea bag, placebo tea bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rong-Yang Zhengyifang" tea bagOther
One tea bag is 4 grams, 3 bags per day, for a total of 7 days
placebo tea bagOther
One tea bag is 4 grams, 3 bags per day, for a total of 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: placebo tea bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7days
Secondary outcomes (1)
Rapid screening reagent screening
Comparison of the number of days from a positive diagnosis of rapid screening to a negative test
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start15 Aug 2022
- Primary completion28 Feb 2023
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herbal InteractionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1. Parallel study design. 2. There is a control group (placebo). 3. Blinding method: non-blind. 4. Random assignment: yes
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yen-Ying Kung, doctor, Study chair, TaipeiVGH Center for Traditional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504447
- Sponsor's protocol ID
- 2022-06-007B
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2022
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of "Rongyang Zhengyifang" Tea Bag in Mildly Diagnosed Patients With COVID-19 Variant Virus
- ClinicalTrials.gov ID
- NCT05504447
- Acronym / sponsor ID
- 2022-06-007B
- Conditions
- Herbal Interaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Parallel study design. 2. There is a control group (placebo). 3. Blinding method: non-blind. 4. Random assignment: yes
| Arm | Type | Receives |
|---|---|---|
| Rong-Yang Zhengyifang" tea bag | Experimental | Other: Rong-Yang Zhengyifang" tea bag1. 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. |
| placebo tea bag | Placebo comparator | Other: placebo tea bagThe appearance is exactly the same as the Zhengyifang tea bag, and the ingredient is oolong tea |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rong-Yang Zhengyifang" tea bagOne tea bag is 4 grams, 3 bags per day, for a total of 7 days | Other | Rong-Yang Zhengyifang" tea bag |
| placebo tea bagOne tea bag is 4 grams, 3 bags per day, for a total of 7 days | Other | placebo tea bag |
Primary outcome
Questionnaire Evaluation
Time frame: 7days
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.
1 secondary outcome
Rapid screening reagent screening
Time frame: 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Ying Kung, doctor study chair
TaipeiVGH Center for Traditional Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rong-Yang Zhengyifang" tea bag in people with Herbal Interaction, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Evaluation (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.