- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04702659
Chinese Medicine Zhengyi Prescription Tea Bag
The Study of Clinical Observation About Chinese Medicine Zhengyi Prescription
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Taipei, 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
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
28days
|
Collaborators and Investigators
Investigators
- Principal Investigator: chang kaiwei, master, TaipeiVGH Center for Traditional Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2020-10-002B
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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