Acute Upper Respiratory InfectionPhase 4NCT02539277
A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection
A Phase 4 study testing Jinyebaidu granule and Fufangshuanghua granule in people with Acute Upper Respiratory Infection, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Upper Respiratory Infection
- What is being tested?
- Jinyebaidu granule and Fufangshuanghua granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Nov 2015
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Yuan Li, bachelor contact
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Wensheng Qi
About this study
Official title: A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial
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
Read the detailed description
- Inclusion criteria
- 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.
- Effectiveness evaluation
- TCM symptoms: fever, sore throat, cough with or without expectoration, headache, thirst, change of tongue body, tongue coating and pulse.
- Signs: swollen tonsils, pharyngeal hyperemia.
- Body temperature
- Safety evaluation
- Clinical symptoms and signs of adverse event reaction
- Signs: blood pressure, respiration, heart rate, body temperature;
- Routine blood test and urine routine;
- Liver function and renal function: Alanine transaminase (ALT)、glutamic-oxalacetic transaminease(AST)、serum creatinine(SCr)、urea nitrogen(BUN) ;
- Incidence of electrocardiogram(ECG) abnormalities.
- Cost-effectiveness evaluation cost calculation
- The direct medical costs include: the registration expenses, examination expenses, laboratory test expenses, Treatment costs, Chinese medicine expenses, Chinese herbal medicine expenses, western medicine expenses; Indirect medical costs: transportation costs, lost income patients; Adverse drug reactions cost: the cost of treatment due to adverse drug reactions.
- Effect Evaluation:Symptoms and signs score, physical examination, the incidence of complications.
- Number of participants 600 participants will be divided into two groups, the experimental group (n=300)and the control group (n=300).Each group will be stratified into three layers according to fever, sore throat, fever and sore throats. 100 patients will be included in each level.
- Dose regimen
- treatment group: Jinyebaidu granule, blunt, 10g/time, three times a day; Compound Shuanghua granules placebo, blunt, 6g /time, 4 times a day.
- Control group: Compound double flowers particles, blunt, 6g/time, 4 times a day; Jinyebaidu Granule placebo, blunt, 10g/time, three times a day.
- Course of treatment：5 days
- Conditions
- Acute Upper Respiratory Infection
- Being tested
- Jinyebaidu granule, Fufangshuanghua granule, Jinyebaidu granule placebo, Fufangshuanghua granule placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jinyebaidu granuleDrug
It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.
Fufangshuanghua granuleDrug
It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.
Jinyebaidu granule placeboDrug
It is Jinyebaidu granule placebo.
Fufangshuanghua granule placeboDrug
It is Fufangshuanghua granule placebo.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Jinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day. Receives: Drug: Jinyebaidu granule; Drug: Fufangshuanghua granule placebo |
| Control group | Active comparator | Fufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day. Receives: Drug: Fufangshuanghua granule; Drug: Jinyebaidu granule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to defervescence
Measured: 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
The symptoms includes sore throat, cough, expectoration, headache, thirst. According to severity ,each symptom include four grades. The scores of sore throat are 0,2,4,6. The scores of cough, expectoration ,headache, thirst are 0,1,2,3. Compare the change from baseline all of symptoms score at the third day and at the fifth day.
References: Mao bing, Li ting-qian, Li ming-quan, Tu jin-wen, Zhang rui-ming, et al. Clinical randomized double--blinded observation on effect of Jinyebaidu Granule in treating the disease of wind-heat attacking the lung(type of heat pathogen invading the defensive Qi of the lung). chinese JounIal of Evidence-Based Medicine Jun, 2003,3(2):115-120
Measured: change from baseline symptoms score at the third day and at the fifth day
Change of signs score
The signs includes swollen tonsils and pharyngeal hyperemia. According to severity, each sign includes four grades. The scores are 0,4,6,8.
References: Mao bing, Li ting-qian, Li ming-quan, Tu jin-wen, Zhang rui-ming, et al. Clinical randomized double--blinded observation on effect of Jinyebaidu Granule in treating the disease of wind-heat attacking the lung(type of heat pathogen invading the defensive Qi of the lung). chinese JounIal of Evidence-Based Medicine Jun, 2003,3(2):115-120
Measured: change from baseline signs score at the fifth day
Adverse events
Measured: All the time in the study
Change of routine blood test
The routine blood test includes white blood cell count, neutral cell ratio, lymphocyte ratio, single nuclear cell ratio, red blood cell count, hemoglobin, platelet count
Measured: Change from base line, on the fifth day
Change of urine routine
The urine routine includes white blood cell count, red blood cell count,urine protein,urine sugar
Measured: Change from base line, on the fifth day
Change of liver function
The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase
Measured: Change from base line, on the fifth day
Change of renal function
The renal function includes creatinine,usea nitrogen
Measured: Change from base line, on the fifth day
Incidence of ECG abnormalities
Measured: Change from base line, on the fifth day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startDec 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Heilongjiang Chinese Medicine University, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine, Changchun University of Chinese Medicine, Liaoning University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Junjie Jiang, China Academy of Chinese Medical Sciences
- Investigators
- Yanming Xie, Study chair, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539277
- Sponsor's protocol ID
- 20141107-3.0
- Status last verified
- Aug 2015
- First submitted
- 18 Apr 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02539277
- Acronym / sponsor ID
- 20141107-3.0
- Conditions
- Acute Upper Respiratory Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Heilongjiang Chinese Medicine University, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine, Changchun University of Chinese Medicine, Liaoning University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 3 Sep 2015 (estimated)
- 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.
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
Detailed description
- Inclusion criteria
- 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.
- Effectiveness evaluation
- TCM symptoms: fever, sore throat, cough with or without expectoration, headache, thirst, change of tongue body, tongue coating and pulse.
- Signs: swollen tonsils, pharyngeal hyperemia.
- Body temperature
- Safety evaluation
- Clinical symptoms and signs of adverse event reaction
- Signs: blood pressure, respiration, heart rate, body temperature;
- Routine blood test and urine routine;
- Liver function and renal function: Alanine transaminase (ALT)、glutamic-oxalacetic transaminease(AST)、serum creatinine(SCr)、urea nitrogen(BUN) ;
- Incidence of electrocardiogram(ECG) abnormalities.
- Cost-effectiveness evaluation cost calculation
- The direct medical costs include: the registration expenses, examination expenses, laboratory test expenses, Treatment costs, Chinese medicine expenses, Chinese herbal medicine expenses, western medicine expenses; Indirect medical costs: transportation costs, lost income patients; Adverse drug reactions cost: the cost of treatment due to adverse drug reactions.
- Effect Evaluation:Symptoms and signs score, physical examination, the incidence of complications.
- Number of participants 600 participants will be divided into two groups, the experimental group (n=300)and the control group (n=300).Each group will be stratified into three layers according to fever, sore throat, fever and sore throats. 100 patients will be included in each level.
- Dose regimen
- treatment group: Jinyebaidu granule, blunt, 10g/time, three times a day; Compound Shuanghua granules placebo, blunt, 6g /time, 4 times a day.
- Control group: Compound double flowers particles, blunt, 6g/time, 4 times a day; Jinyebaidu Granule placebo, blunt, 10g/time, three times a day.
- Course of treatment：5 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Jinyebaidu granule, Drug: Fufangshuanghua granule placeboJinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day. |
| Control group | Active comparator | Drug: Fufangshuanghua granule, Drug: Jinyebaidu granule placeboFufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| Jinyebaidu granuleIt is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb. | Drug | Treatment group |
| Fufangshuanghua granuleIt is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata. | Drug | Control group |
| Jinyebaidu granule placeboIt is Jinyebaidu granule placebo. | Drug | Control group |
| Fufangshuanghua granule placeboIt is Fufangshuanghua granule placebo. | Drug | Treatment group |
Primary outcome
The time to defervescence
Time frame: defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.3ºC
8 secondary outcomes
Change of symptoms score
Time frame: change from baseline symptoms score at the third day and at the fifth day
Change of signs score
Time frame: change from baseline signs score at the fifth day
Adverse events
Time frame: All the time in the study
Change of routine blood test
Time frame: Change from base line, on the fifth day
Change of urine routine
Time frame: Change from base line, on the fifth day
Change of liver function
Time frame: Change from base line, on the fifth day
Change of renal function
Time frame: Change from base line, on the fifth day
Incidence of ECG abnormalities
Time frame: Change from base line, on the fifth day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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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.
Yuan Li, bachelor contact
Yanming Xie study chair
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jinyebaidu granule and Fufangshuanghua granule in people with Acute Upper Respiratory Infection, run by China Academy of Chinese Medical Sciences at 1 site in China.
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 5 inclusion and 11 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 Sep 2015. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Junjie Jiang, doctor (86-18910206360, studentjiangjunjie@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to defervescence (time frame: defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.3ºC). 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 Sep 2015.