Phase IIaTrials of GanMaoKangNing Granules

NCT02989012 | Unknown Phase 2

• 1 other identifier: DalianZhen-Ao
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidemic Influenza

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Single symptom remission rate

  six days

• The antifebrile effect

  six days

Other Outcomes (1)

• The conditions of drug utilization of the antipyretic and some cough medicine

  six days

Study Arms (2)

Drugs for experimental group

EXPERIMENTAL

GanMaoKangNing Granules， blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous Oseltamivir Phosphate Capsules,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).

Drug: GanMaoKangNing Granules; Drug: Analogous Oseltamivir Phosphate Capsules

Drugs for control group

SHAM COMPARATOR

Oseltamivir Phosphate Capsules ,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous GanMaoKangNing Granules, blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).

Drug: Oseltamivir Phosphate Capsules; Drug: Analogous GanMaoKangNing Granules

Interventions

GanMaoKangNing Granules DRUG

3 times a day, 2 bags each time.

Drugs for experimental group

Analogous Oseltamivir Phosphate Capsules DRUG

2 times a day,1 capsule each time.

Drugs for experimental group

Oseltamivir Phosphate Capsules DRUG

2 times a day,1 capsule each time.

Drugs for control group

Analogous GanMaoKangNing Granules DRUG

3 times a day, 2 bags each time.

Drugs for control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dalian Zhen-Ao Bio-Tech Co., Ltd.: lead

Study Sites (1)

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100010, China

Location

Related Links

• WHO. Influenza（Seasonal）\[EB/OL\].\[2015-12-31\]

MeSH Terms

Interventions

Oseltamivir

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 12, 2016
• Primary Completion: July 1, 2019
• Last Updated: December 12, 2016

Record last verified: 2016-11

Locations

CN (1)