Epidemic InfluenzaPhase 2NCT02989012
Phase IIaTrials of GanMaoKangNing Granules
A Phase 2 study testing GanMaoKangNing Granules, Analogous Oseltamivir Phosphate Capsules and Oseltamivir Phosphate Capsules in people with Epidemic Influenza, run by Dalian Zhen-Ao Bio-Tech Co., Ltd. at 1 site in China.
Trial summary
Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled, multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the symptoms of influenza. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epidemic Influenza
- What is being tested?
- GanMaoKangNing Granules, Analogous Oseltamivir Phosphate Capsules and Oseltamivir Phosphate Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Start not givento Jul 2019
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent;
- Male and female patients aged between 18 and 65 years old , there is no limit on the gender;
- In line with the diagnostic criteria for pandemic influenza;
- Duration less than 48 (Duration is defined as the time from onset to test drugs for the first time before, the onset time pointed out that now the axillary temperature 38.0 ℃, headache, muscle or joint pain, chills, fatigue, cough, sore throat and a stuffy nose eight any flu symptoms and signs in time);
- The axillary temperature is 38.0 ℃ or higher;
- Nose and throat swabs rapid virus antigen test result is positive.
Who cannot join
- Severe influenza and of patients with complications of influenza.
- With the following any severe risk factors:
- With chronic respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease (copd), etc.
- with chronic diseases of the cardiovascular system, such as congestive heart failure, high blood pressure.
- with chronic metabolic and endocrine system diseases, such as poorly controlled diabetes (HbA1c 7.0% or higher).
- with chronic kidney disease, chronic liver disease, blood system diseases, neurological and neuromuscular diseases (such as epilepsy, cognitive impairment, etc.).
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- A weakened immune system, such as long-term use of immunosuppressive agents, HIV infection or tumor.
- Under the age of 19, long-term aspirin use. G. The obese (BMI BMI > 30).
- With influenza complications, such as secondary bacterial pneumonia and other pathogenic bacteria and other viral pneumonia caused by pneumonia.
- A history of peptic ulcer disease or gastrointestinal bleeding.
- Into the group received within 48 h before flu antiviral treatment.
- Into the group of 12 months before been vaccinated against the flu.
- Into the group used within 2 weeks before the monoamine oxidase inhibitors.
- Blood leukocyte count > 10.0 x 109 / L, neutrophils ratio > 80%, or the need for systemic antibiotic therapy.
- For GanMaoKangNing Granules, Oseltamivir Phosphate Capsules, Acetaminophen Tablets, Dextromethorphan Hydrobromide Capsule, GanMaoKangNing Granules simulation agent or Oseltamivir Phosphate Capsules simulation agent composition of allergy, or allergic constitution.
- Aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 1.5 x Upper Limit Normal (ULN)， Scr > Upper Limit Normal (ULN).
- Doubt or does have a history of alcohol or drug abuse.
- Pregnancy (defined as the pregnancy test positive), nursing mothers, or past in family planning.
- For nearly three months participated in other clinical trials of patients.
- Researchers think not appropriate to participate in this clinical subjects.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100010
Jing Wang Jing Wang, Dr., 010-64011516, lunlihui@163.com
QingQuan Liu Liu QingQuan, Dr.
About this study
Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled, multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the symptoms of influenza.
- Conditions
- Epidemic Influenza
- Being tested
- GanMaoKangNing Granules, Analogous Oseltamivir Phosphate Capsules, Oseltamivir Phosphate Capsules, Analogous GanMaoKangNing Granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanMaoKangNing GranulesDrug
3 times a day, 2 bags each time.
Analogous Oseltamivir Phosphate CapsulesDrug
2 times a day,1 capsule each time.
Oseltamivir Phosphate CapsulesDrug
2 times a day,1 capsule each time.
Analogous GanMaoKangNing GranulesDrug
3 times a day, 2 bags each time.
| Study group | Role | What they receive |
|---|---|---|
| Drugs for experimental group | Experimental | GanMaoKangNing Granules， blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous Oseltamivir Phosphate Capsules,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.). Receives: Drug: GanMaoKangNing Granules; Drug: Analogous Oseltamivir Phosphate Capsules |
| Drugs for control group | Sham comparator | Oseltamivir Phosphate Capsules ,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous GanMaoKangNing Granules, blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.). Receives: Drug: Oseltamivir Phosphate Capsules; Drug: Analogous GanMaoKangNing Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flu recovery time
All the time needed for symptoms eased that from medication to fever and headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.
Measured: six days
Secondary outcomes (2)
Single symptom remission rate
After the medication and three days later, The proportion of each individual symptoms of subjects which include of headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.
Symptoms defined as symptom scores dropped to 0 or 1 minute, and maintain for 24 h or more.
Measured: six days
The antifebrile effect
Antifebrile rate: After the medication and three days later, the percentage of Body temperature returned to normal subjects (the axillary temperature < 37.1 ℃, and maintain of 24 h or more time).
Medicine antifebrile time (h) : Medication for the first time to the axillary temperature < 37.1 ℃, and maintain of 24 h or more time.
Measured: six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Primary completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidemic InfluenzaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalian Zhen-Ao Bio-Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989012
- Sponsor's protocol ID
- DalianZhen-Ao
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIaTrials of GanMaoKangNing Granules
- ClinicalTrials.gov ID
- NCT02989012
- Acronym / sponsor ID
- DalianZhen-Ao
- Conditions
- Epidemic Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Dalian Zhen-Ao Bio-Tech Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Jul 2019 (estimated)
- First posted
- 12 Dec 2016 (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.
Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled, multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the symptoms of influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drugs for experimental group | Experimental | Drug: GanMaoKangNing Granules, Drug: Analogous Oseltamivir Phosphate CapsulesGanMaoKangNing Granules， blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous Oseltamivir Phosphate Capsules,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.). |
| Drugs for control group | Sham comparator | Drug: Oseltamivir Phosphate Capsules, Drug: Analogous GanMaoKangNing GranulesOseltamivir Phosphate Capsules ,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous GanMaoKangNing Granules, blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign the informed consent;
- Male and female patients aged between 18 and 65 years old , there is no limit on the gender;
- In line with the diagnostic criteria for pandemic influenza;
- Duration less than 48 (Duration is defined as the time from onset to test drugs for the first time before, the onset time pointed out that now the axillary temperature 38.0 ℃, headache, muscle or joint pain, chills, fatigue, cough, sore throat and a stuffy nose eight any flu symptoms and signs in time);
- The axillary temperature is 38.0 ℃ or higher;
Key exclusion criteria (20 listed)
- Severe influenza and of patients with complications of influenza.
- With the following any severe risk factors:
- With chronic respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease (copd), etc.
- with chronic diseases of the cardiovascular system, such as congestive heart failure, high blood pressure.
- with chronic metabolic and endocrine system diseases, such as poorly controlled diabetes (HbA1c 7.0% or higher).
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 |
|---|---|---|
| GanMaoKangNing Granules3 times a day, 2 bags each time. | Drug | Drugs for experimental group |
| Analogous Oseltamivir Phosphate Capsules2 times a day,1 capsule each time. | Drug | Drugs for experimental group |
| Oseltamivir Phosphate Capsules2 times a day,1 capsule each time. | Drug | Drugs for control group |
| Analogous GanMaoKangNing Granules3 times a day, 2 bags each time. | Drug | Drugs for control group |
Primary outcome
Flu recovery time
Time frame: six days
All the time needed for symptoms eased that from medication to fever and headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.
2 secondary outcomes
Single symptom remission rate
Time frame: six days
The antifebrile effect
Time frame: six days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- WHO. Influenza（Seasonal）\[EB/OL\].\[2015-12-31\]Link provided by the sponsor.
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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.
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GanMaoKangNing Granules, Analogous Oseltamivir Phosphate Capsules and Oseltamivir Phosphate Capsules in people with Epidemic Influenza, run by Dalian Zhen-Ao Bio-Tech Co., Ltd. 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 6 inclusion and 20 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 12 Dec 2016. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flu recovery time (time frame: six days). 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 12 Dec 2016.