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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.). |
|
| 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.). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GanMaoKangNing Granules | Drug | 3 times a day, 2 bags each time. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University | Beijing | Beijing Municipality | 100010 | China |
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| Label | URL |
|---|---|
| WHO. Influenza(Seasonal)\[EB/OL\].\[2015-12-31\] | View source |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Analogous Oseltamivir Phosphate Capsules |
| Drug |
2 times a day,1 capsule each time. |
|
| Oseltamivir Phosphate Capsules | Drug | 2 times a day,1 capsule each time. |
|
| Analogous GanMaoKangNing Granules | Drug | 3 times a day, 2 bags each time. |
|
| 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 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |