Herbal InteractionNCT04702659
Chinese Medicine Zhengyi Prescription Tea Bag
An observational study of Herbal Interaction, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Chinese herbal tea bags can adjust physiological functions, help protect power, and give positive energy to the body. This prescription not only focuses on regulating the patient's physical function, but also helps to enhance physical strength. 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
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2021to 15 Jun 2022
- Phase
- Observational
- 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
Study population: Participants have no chronic respiratory disease or those who have been diagnosed as nasal and sinusitis by a doctor, whose clinical diagnosis includes subjects with allergic rhinitis.
Who may be able to join
- Adults over the age of 20, those who have no chronic respiratory disease or those who have been diagnosed as nasal and sinusitis by a doctor, whose clinical diagnosis includes subjects with allergic rhinitis.
Who cannot join
- Patient characteristics: age, gender, weight, education level, race, pregnancy and breastfeeding status, smoking, drinking, caffeine, alcohol or drug poisoning, diet and nutritional status, physical limitations, genetic history, etc. Exclude women under the age of 20, unable to order their behavior, pregnant or breast-feeding women
- Disease characteristics: Subjects who have been diagnosis of mental illness by doctors, as well as long-term diarrhea or long-term use of Chinese medicine.
- Environmental characteristics: other conditions that make patients unable to cooperate. Such as unsuitability after screening, not signing the subject consent form, etc.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Center for Traditional Medicine, Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: The Study of Clinical Observation About Chinese Medicine Zhengyi Prescription
Chinese herbal tea bags can adjust physiological functions, help protect power, and give positive energy to the body. This prescription not only focuses on regulating the patient's physical function, but also helps to enhance physical strength.
Read the detailed description
In Taiwan ,acoording to the TCM theories and viewpoints, Chinese herbal medicine plays an important role in clinical drug application.TCM compound combinations for different diseases, emphasizing the complementarity and balance of ingredients, natural gentleness, uniqueness and efficacy are widely accepted by the public.
- Conditions
- Herbal Interaction
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire-the Chinese Version of the 31-Item Rhinosinusitis Outcome Measure
The questionnaire contains a total of 31 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 four weeks,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: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start10 Jan 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- chang kaiwei, master, Principal investigator, TaipeiVGH Center for Traditional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702659
- Sponsor's protocol ID
- 2020-10-002B
- Status last verified
- Aug 2022
- First submitted
- 6 Jan 2021
- Last updated
- 17 Aug 2022
- 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 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Clinical Observation About Chinese Medicine Zhengyi Prescription
- ClinicalTrials.gov ID
- NCT04702659
- Acronym / sponsor ID
- 2020-10-002B
- Conditions
- Herbal Interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 11 Jan 2021 (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.
Chinese herbal tea bags can adjust physiological functions, help protect power, and give positive energy to the body. This prescription not only focuses on regulating the patient's physical function, but also helps to enhance physical strength.
Detailed description
In Taiwan ,acoording to the TCM theories and viewpoints, Chinese herbal medicine plays an important role in clinical drug application.TCM compound combinations for different diseases, emphasizing the complementarity and balance of ingredients, natural gentleness, uniqueness and efficacy are widely accepted by the public.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants have no chronic respiratory disease or those who have been diagnosed as nasal and sinusitis by a doctor, whose clinical diagnosis includes subjects with allergic rhinitis.
Key inclusion criteria (1 listed)
- Adults over the age of 20, those who have no chronic respiratory disease or those who have been diagnosed as nasal and sinusitis by a doctor, whose clinical diagnosis includes subjects with allergic rhinitis.
Key exclusion criteria (3 listed)
- Patient characteristics: age, gender, weight, education level, race, pregnancy and breastfeeding status, smoking, drinking, caffeine, alcohol or drug poisoning, diet and nutritional status, physical limitations, genetic history, etc. Exclude women under the age of 20, unable to order their behavior, pregnant or breast-feeding women
- Disease characteristics: Subjects who have been diagnosis of mental illness by doctors, as well as long-term diarrhea or long-term use of Chinese medicine.
- Environmental characteristics: other conditions that make patients unable to cooperate. Such as unsuitability after screening, not signing the subject 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.
Primary outcome
questionnaire-the Chinese Version of the 31-Item Rhinosinusitis Outcome Measure
Time frame: 28days
The questionnaire contains a total of 31 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 four weeks,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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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.
chang kaiwei, master principal investigator
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?
An observational study of 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: finished, as of the sponsor's last update on 17 Aug 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-the Chinese Version of the 31-Item Rhinosinusitis Outcome Measure (time frame: 28days). 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 17 Aug 2022.