Banlangen Granules Anti-seasonal Influenza Study (BLG)

• ClinicalTrials.gov Identifier: NCT02232945
• Recruitment Status: Unknown
• First Posted: September 5, 2014
• Last Update Posted: March 4, 2016
• Sponsor: Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
• Collaborator: Guangzhou Institute of Respiratory Disease
• Information provided by (Responsible Party): Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Influenza	Drug: placebo of oseltamivir phosphate; Drug: oseltamivir phosphate; Drug: Banlangen (Radix Isatidis) granules; Drug: placebo of Banlangen(Radix Isatidis) granules	Phase 4

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)

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).

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 177 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Banlangen Granules Anti-seasonal Influenza Study: a Randomized, Double Blind, Positive and Placebo Controlled，Clinical Study.
• Study Start Date: April 2012
• Estimated Primary Completion Date: August 2016
• Estimated Study Completion Date: November 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: placebo; placebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules.	Drug: placebo of oseltamivir phosphate; Drug: placebo of Banlangen(Radix Isatidis) granules
Experimental: Banlangen granules & placebo; Banlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate	Drug: placebo of oseltamivir phosphate; Drug: Banlangen (Radix Isatidis) granules
Active Comparator: oseltamivir phosphate & placebo; oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules	Drug: oseltamivir phosphate; Drug: placebo of Banlangen(Radix Isatidis) granules

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. others [ Time Frame: 21+7days ]
   viral shedding duration, defined as the time from the illness onset to the first time the viral nucleic acid test was negative
2. Others [ Time Frame: 21+7days ]
   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. Others [ Time Frame: 21+7days ]
   frequency of Usage of Acetaminophen
4. Others [ Time Frame: 21+7days ]
   incidence of secondary complications of influenza
5. Others [ Time Frame: 21+7days ]
   economic evaluation

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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.

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)

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).

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.

Contacts and Locations

Contacts

Contact: Yuedong Cai, Master; 86-20-66282326; caiyuedong@813zy.com

Locations

China, Guangdong

Guangzhou Institute of Respiratory Disease; Recruiting

Guangzhou, Guangdong, China, 510230

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

Principal Investigator: N S Zhong, PHD

Sponsors and Collaborators

Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited

Guangzhou Institute of Respiratory Disease

Investigators

• Study Chair: Nanshan Zhong, PhD; Guangzhou Institute of Respiratory Disease

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
• ClinicalTrials.gov Identifier: NCT02232945
• Other Study ID Numbers: HWBY-001
• First Posted: September 5, 2014
• Last Update Posted: March 4, 2016
• Last Verified: March 2016

Keywords provided by Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited:

influenza A (H1N1,H3N2); influenza B virus

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Oseltamivir; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action