A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection
1 other identifier
interventional
600
1 country
1
Brief Summary
Study topic：A comparative effectiveness research on Jinyebaidu granule in treating patients with acute upper respiratory infection: A double blind, double dummy, randomized, controlled trial. It is a post-marketing clinical study to evaluate effectiveness, safety and cost-effectiveness on Jinyebaidu granule in treating acute upper respiratory infection. Objectives of Study：This study aims to evaluate effectiveness, safety and cost-effectiveness on Jinyebaidu granule in treating patients with acute upper respiratory infection. Study design：multi-center double-blind, double-dummy, randomized, controlled trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 18, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedSeptember 3, 2015
August 1, 2015
11 months
April 18, 2015
September 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The time to defervescence
defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.3ºC
Secondary Outcomes (8)
Change of symptoms score
change from baseline symptoms score at the third day and at the fifth day
Change of signs score
change from baseline signs score at the fifth day
Adverse events
All the time in the study
Change of routine blood test
Change from base line, on the fifth day
Change of urine routine
Change from base line, on the fifth day
- +3 more secondary outcomes
Study Arms (2)
Treatment group
EXPERIMENTALJinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day.
Control group
ACTIVE COMPARATORFufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day.
Interventions
It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.
It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.
Eligibility Criteria
You may qualify if:
- Patients diagnosed as acute upper respiratory infection.
- Patients with acute upper respiratory infection diagnosed as Traditional Chinese Medicine(TCM) syndrome wind-heat attacking the Lung (type of heat pathogen invading the defensive Qi of the lung).
- Acute upper respiratory infection onset time is less than 36 hours.
- Patients aged 18 to 70 years old.
- Patients agreed to participate this study and sign the informed consent.
You may not qualify if:
- Patients diagnosed with suppurative tonsillitis (third degree), and chest X-ray imaging showed lung inflammation;
- White blood cell counts more than 12 E9, neutrophils more than 80%, ALT, AST, BUN, Cr more than 2 times of the normal upper limit;
- Patients with temperature lower than 37.5 degree centigrade, and without sore throat;
- Patients with temperature higher than 38.5 degree centigrade;
- Patients already receiving antibiotics or other similar drug treatment;
- Patients associated with other severe primary lung diseases, such as lung cancer, tuberculosis, pneumonia and other infectious diseases;
- Patients complicated with cardiovascular and cerebrovascular diseases, severe primary diseases of hematopoietic system, mental illness;
- Pregnant or lactating women;
- Patients with immunodeficiency resulted from organ transplantation, HIV / AIDS, or long-term use of immunosuppressive agents;
- Patients with drug allergy;
- Patients participating in other clinical trials, which influence outcome evaluation of the research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Academy of Chinese Medical Scienceslead
- First Affiliated Hospital of Heilongjiang Chinese Medicine Universitycollaborator
- Guang'anmen Hospital of China Academy of Chinese Medical Sciencescollaborator
- Beijing Hospital of Traditional Chinese Medicinecollaborator
- Changchun University of Chinese Medicinecollaborator
- Liaoning University of Traditional Chinese Medicinecollaborator
- Shandong University of Traditional Chinese Medicinecollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
Study Sites (1)
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053, China
Study Officials
- STUDY CHAIR
Yanming Xie
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant researcher
Study Record Dates
First Submitted
April 18, 2015
First Posted
September 3, 2015
Study Start
December 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
September 3, 2015
Record last verified: 2015-08