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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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).
Show all 10Show fewer
  • 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.

Yuedong Cai, Master contact

86-20-66282326

caiyuedong@813zy.com

China1 site, 1 recruiting
  • Guangzhou Institute of Respiratory Disease

    Guangzhou, Guangdong, 510230

    Nan S Zhong, PHD, 020-83062718, nanshan@vip.163.com

    N S Zhong, PHD

    Recruiting

Other trials in China

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:

  1. Patients have confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time PCR
  2. age between 18-65 years old
  3. axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ,or fatigue) and one respiratory symptom (cough ,sore throat,or coryza) .
  4. Illness onset had to be within 36 hours, and informed consent was obtained.

Exclusion criteria:

  1. age younger than 18 or older than 65 years old.
  2. patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) .
  3. Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%.
  4. Those have got suppurative tonsillitis or cough purulent sputum.
  5. 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)
  6. 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).
  7. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.
  8. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization.
  9. Two weeks before the test , those with acute respiratory Infection,otitis,or nasosinusitis .
  10. 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:

  1. 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.
  2. 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 groups in NCT02232945
Study groupRoleWhat they receive
placeboPlacebo comparatorplacebo 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 & placeboExperimentalBanlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate
Receives: Drug: placebo of oseltamivir phosphate; Drug: Banlangen (Radix Isatidis) granules
oseltamivir phosphate & placeboActive comparatoroseltamivir 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. Others

    frequency of Usage of Acetaminophen

    Measured: 21+7days

  4. Others

    incidence of secondary complications of influenza

    Measured: 21+7days

  5. 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.

  1. First posted5 Sep 2014 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2016 (estimated)
  4. Study completionNov 2016 (estimated)

Resources

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)
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

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.

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