Epidemic Influenza Clinical Trial
| NCT number | NCT02989012 |
| Other study ID # | DalianZhen-Ao |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | Phase 2 |
| First received | November 30, 2016 |
| Last updated | December 7, 2016 |
| Verified date | November 2016 |
| Source | Dalian Zhen-Ao Bio-Tech Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | CFDA:China |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 96 |
| Est. completion date | |
| Est. primary completion date | July 2019 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Severe influenza and of patients with complications of influenza. - With the following any severe risk factors: A. With chronic respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease (copd), etc. B. with chronic diseases of the cardiovascular system, such as congestive heart failure, high blood pressure. C. with chronic metabolic and endocrine system diseases, such as poorly controlled diabetes (HbA1c 7.0% or higher). D. with chronic kidney disease, chronic liver disease, blood system diseases, neurological and neuromuscular diseases (such as epilepsy, cognitive impairment, etc.). E. A weakened immune system, such as long-term use of immunosuppressive agents, HIV infection or tumor. F. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University | Beijing Shi | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Dalian Zhen-Ao Bio-Tech Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The conditions of drug utilization of the antipyretic and some cough medicine | Including acetaminophen tablets and capsule of dextromethorphan hydrobromide usage rate and dose. | six days | Yes |
| Primary | 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. | six days | Yes |
| Secondary | 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. |
six days | Yes |
| Secondary | 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. |
six days | Yes |