InfluenzaPhase 4BLGNCT02232945
Banlangen Granules Anti-seasonal Influenza Study
A Phase 4 study testing oseltamivir phosphate and Banlangen (Radix Isatidis) granules in people with Influenza, run by Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited at 1 site in China.
Trial summary
This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- oseltamivir phosphate and Banlangen (Radix Isatidis) granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Nov 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR (rRT-PCR), age between 18-65 years old, axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ,or fatigue) and one respiratory symptom (cough ,sore throat,or coryza) . Illness onset had to be within 36 hours, and informed consent was obtained.
Who cannot join
- age younger than 18 or older than 65 years old.
- patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) .
- Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%.
- Those have got suppurative tonsillitis or cough purulent sputum.
- Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease(FEV1/FVC<70%,FEV1/ predicated value<50%; or respiratory failure or right heart failure), hepatic disease(ALT or AST≥triple ULN), renal disease(Serum Creatinine>2mg/dL),chronic congestive heart failure( NYHA Ⅲ-IV)
- 7. Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more).
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- 9. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.
- 10. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization.
- 12. Two weeks before the test , those with acute respiratory Infection,otitis,or nasosinusitis .
- 13. Those already vaccinated or who will receive influenza vaccine. 14.other reasons not suitable for enrollment based on the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510230
Nan S Zhong, PHD, 020-83062718, nanshan@vip.163.com
N S Zhong, PHD
About this study
Official title: Banlangen Granules Anti-seasonal Influenza Study: a Randomized, Double Blind, Positive and Placebo Controlled,Clinical Study.
This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.
Read the detailed description
Inclusion criteria:
- Patients have confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time PCR
- age between 18-65 years old
- axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ,or fatigue) and one respiratory symptom (cough ,sore throat,or coryza) .
- Illness onset had to be within 36 hours, and informed consent was obtained.
Exclusion criteria:
- age younger than 18 or older than 65 years old.
- patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) .
- Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%.
- Those have got suppurative tonsillitis or cough purulent sputum.
- Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease(FEV1/FVC<70%,FEV1/ predicated value<50%; or respiratory failure or right heart failure), hepatic disease(ALT or AST≥triple ULN), renal disease(Serum Creatinine>2mg/dL),chronic congestive heart failure( NYHA Ⅲ-IV)
- Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more).
- Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.
- Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization.
- Two weeks before the test , those with acute respiratory Infection,otitis,or nasosinusitis .
- Those already vaccinated or who will receive influenza vaccine. 14. other reasons not suitable for enrollment based on the investigator's discretion.
The primary efficacy endpoint:
- The primary end point was the duration of illness which was defined as the time from onset of symptoms to the alleviation of the ten influenza-like symptoms including , nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills and sweating.
- 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 37.4ºC and was sustained for at least 24 hours.
Secondary efficacy endpoint:
The secondary end points included: 1) viral shedding duration, defined as the time from the illness onset to the first time the viral nucleic acid test was negative; 2) the severity of the disease,assessed by an area under the curve (AUC) analysis of a total of nine influenza-like symptom scores, the AUC was calculated as the product of the daily symptom scores times the duration of illness;3)frequency of Usage of Acetaminophen;4)and incidence of secondary complications of influenza, such as otitis, bronchitis, pneumonia,Nasosinusitis ,suppurative tonsillitis,acute parotitis,Reye'ssyndrome,central nervous system disease, Myocarditis and pericarditis, acute myositis, and toxic shock syndrome.5) economic evaluation.
Specimen:
the pharyngeal or the throat swab,blood. Pharyngea /throat secretions will be obtained from the upper respiratory tract of each patient.
All specimens will be stored at -80℃ in virus laboratory of the first affiliated hospital of guangzhou medical university for 5 years.
- Conditions
- Influenza
- Being tested
- placebo of oseltamivir phosphate, oseltamivir phosphate, Banlangen (Radix Isatidis) granules, placebo of Banlangen(Radix Isatidis) granules
- Keywords
- influenza A (H1N1,H3N2), influenza B virus
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo of oseltamivir phosphateDrug
oseltamivir phosphateDrug
Banlangen (Radix Isatidis) granulesDrug
placebo of Banlangen(Radix Isatidis) granulesDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules. Receives: Drug: placebo of oseltamivir phosphate; Drug: placebo of Banlangen(Radix Isatidis) granules |
| Banlangen granules & placebo | Experimental | Banlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate Receives: Drug: placebo of oseltamivir phosphate; Drug: Banlangen (Radix Isatidis) granules |
| oseltamivir phosphate & placebo | Active comparator | oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules Receives: Drug: oseltamivir phosphate; Drug: placebo of Banlangen(Radix Isatidis) granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving the flu-like symptoms, such as fever etc
The primary end point was the duration of illness which was defined as the time from onset of symptoms to the alleviation of the ten influenza-like symptoms including , nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills and sweating.
Measured: 21+7days
Improving the flu-like symptoms, such as fever etc
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 37.4ºC and was sustained for at least 24 hours.
Measured: 21+7days
Secondary outcomes (5)
others
viral shedding duration, defined as the time from the illness onset to the first time the viral nucleic acid test was negative
Measured: 21+7days
Others
the severity of the disease,assessed by an area under the curve (AUC) analysis of a total of nine influenza-like symptom scores, the AUC was calculated as the product of the daily symptom scores times the duration of illness
Measured: 21+7days
Others
frequency of Usage of Acetaminophen
Measured: 21+7days
Others
incidence of secondary complications of influenza
Measured: 21+7days
Others
economic evaluation
Measured: 21+7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startApr 2012
- Primary completionAug 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Institute of Respiratory Disease
- Responsible party
- Sponsor
- Investigators
- Nanshan Zhong, PhD, Study chair, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232945
- Sponsor's protocol ID
- HWBY-001
- Acronym
- BLG
- Status last verified
- Mar 2016
- First submitted
- 18 Nov 2012
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li ZT, Li L, Chen TT, Li CY, Wang DQ, Yang ZF, Zhong NS. Efficacy and safety of Ban-Lan-Gen granules in the treatment of seasonal influenza: study protocol for a randomized controlled trial. Trials. 2015 Mar 28;16:126. doi: 10.1186/s13063-015-0645-x.
PubMed 25873046
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Banlangen Granules Anti-seasonal Influenza Study: a Randomized, Double Blind, Positive and Placebo Controlled,Clinical Study.
- ClinicalTrials.gov ID
- NCT02232945
- Acronym / sponsor ID
- BLG / HWBY-001
- Conditions
- Influenza
- Keywords
- influenza A (H1N1,H3N2), influenza B virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Guangzhou Institute of Respiratory Disease
- Study start
- Apr 2012
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 5 Sep 2014 (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.
This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.
Detailed description
Inclusion criteria:
- Patients have confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time PCR
- age between 18-65 years old
- axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ,or fatigue) and one respiratory symptom (cough ,sore throat,or coryza) .
- Illness onset had to be within 36 hours, and informed consent was obtained.
Exclusion criteria:
- age younger than 18 or older than 65 years old.
- patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) .
- Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%.
- Those have got suppurative tonsillitis or cough purulent sputum.
- Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease(FEV1/FVC<70%,FEV1/ predicated value<50%; or respiratory failure or right heart failure), hepatic disease(ALT or AST≥triple ULN), renal disease(Serum Creatinine>2mg/dL),chronic congestive heart failure( NYHA Ⅲ-IV)
- Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more).
- Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.
- Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization.
- Two weeks before the test , those with acute respiratory Infection,otitis,or nasosinusitis .
- Those already vaccinated or who will receive influenza vaccine. 14. other reasons not suitable for enrollment based on the investigator's discretion.
The primary efficacy endpoint:
- The primary end point was the duration of illness which was defined as the time from onset of symptoms to the alleviation of the ten influenza-like symptoms including , nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills and sweating.
- 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 37.4ºC and was sustained for at least 24 hours.
Secondary efficacy endpoint:
The secondary end points included: 1) viral shedding duration, defined as the time from the illness onset to the first time the viral nucleic acid test was negative; 2) the severity of the disease,assessed by an area under the curve (AUC) analysis of a total of nine influenza-like symptom scores, the AUC was calculated as the product of the daily symptom scores times the duration of illness;3)frequency of Usage of Acetaminophen;4)and incidence of secondary complications of influenza, such as otitis, bronchitis, pneumonia,Nasosinusitis ,suppurative tonsillitis,acute parotitis,Reye'ssyndrome,central nervous system disease, Myocarditis and pericarditis, acute myositis, and toxic shock syndrome.5) economic evaluation.
Specimen:
the pharyngeal or the throat swab,blood. Pharyngea /throat secretions will be obtained from the upper respiratory tract of each patient.
All specimens will be stored at -80℃ in virus laboratory of the first affiliated hospital of guangzhou medical university for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo of oseltamivir phosphate, Drug: placebo of Banlangen(Radix Isatidis) granulesplacebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules. |
| Banlangen granules & placebo | Experimental | Drug: placebo of oseltamivir phosphate, Drug: Banlangen (Radix Isatidis) granulesBanlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate |
| oseltamivir phosphate & placebo | Active comparator | Drug: oseltamivir phosphate, Drug: placebo of Banlangen(Radix Isatidis) granulesoseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR (rRT-PCR), age between 18-65 years old, axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ,or fatigue) and one respiratory symptom (cough ,sore throat,or coryza) . Illness onset had to be within 36 hours, and informed consent was obtained.
Key exclusion criteria (10 listed)
- age younger than 18 or older than 65 years old.
- patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) .
- Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%.
- Those have got suppurative tonsillitis or cough purulent sputum.
- Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease(FEV1/FVC<70%,FEV1/ predicated value<50%; or respiratory failure or right heart failure), hepatic disease(ALT or AST≥triple ULN), renal disease(Serum Creatinine>2mg/dL),chronic congestive heart failure( NYHA Ⅲ-IV)
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 |
|---|---|---|
| placebo of oseltamivir phosphate | Drug | Banlangen granules & placebo, placebo |
| oseltamivir phosphate | Drug | oseltamivir phosphate & placebo |
| Banlangen (Radix Isatidis) granules | Drug | Banlangen granules & placebo |
| placebo of Banlangen(Radix Isatidis) granules | Drug | oseltamivir phosphate & placebo, placebo |
Primary outcome
Improving the flu-like symptoms, such as fever etc
Time frame: 21+7days
The primary end point was the duration of illness which was defined as the time from onset of symptoms to the alleviation of the ten influenza-like symptoms including , nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills and sweating.
Improving the flu-like symptoms, such as fever etc
Time frame: 21+7days
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 37.4ºC and was sustained for at least 24 hours.
5 secondary outcomes
others
Time frame: 21+7days
Others
Time frame: 21+7days
Others
Time frame: 21+7days
Others
Time frame: 21+7days
Others
Time frame: 21+7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Derived from this study: PubMed 25873046Li ZT, Li L, Chen TT, Li CY, Wang DQ, Yang ZF, Zhong NS. Efficacy and safety of Ban-Lan-Gen granules in the treatment of seasonal influenza: study protocol for a randomized controlled trial. Trials. 2015 Mar 28;16:126. doi: 10.1186/s13063-015-0645-x.
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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.
Nanshan Zhong, PhD study chair
Guangzhou Institute of Respiratory Disease
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 oseltamivir phosphate and Banlangen (Radix Isatidis) granules in people with Influenza, run by Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited 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 1 inclusion and 10 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 4 Mar 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 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 Yuedong Cai, Master (86-20-66282326, caiyuedong@813zy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving the flu-like symptoms, such as fever etc (time frame: 21+7days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232945, which also lists 1 linked publication.
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 4 Mar 2016.