Banlangen Granules Anti-seasonal Influenza Study: a Randomized, Double Blind, Positive and Placebo Controlled,Clinical Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Improving the flu-like symptoms, such as fever etc
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •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.
- •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.
研究组 & 干预措施
placebo
placebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules.
干预措施: placebo of oseltamivir phosphate (Drug)
placebo
placebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules.
干预措施: placebo of Banlangen(Radix Isatidis) granules (Drug)
Banlangen granules & placebo
Banlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate
干预措施: placebo of oseltamivir phosphate (Drug)
Banlangen granules & placebo
Banlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate
干预措施: Banlangen (Radix Isatidis) granules (Drug)
oseltamivir phosphate & placebo
oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules
干预措施: oseltamivir phosphate (Drug)
oseltamivir phosphate & placebo
oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules
干预措施: placebo of Banlangen(Radix Isatidis) granules (Drug)
结局指标
主要结局
Improving the flu-like symptoms, such as fever etc
时间窗: 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.
次要结局
- others(21+7days)
- Others(21+7days)
