A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

Study Overview
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Brief Summary
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This prospective randomized controlled trial studies the efficacy and safety of treating influenza with the reconciling exterior and interior therapy. A total of 300 cases of seasonal flu in Beijing is to be collected, and divided into one treatment group and two control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of treating influenza with the reconciling therapy based on the following outcome measures: the time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it takes for the body temperature to return to normal.

Conditions
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Influenza

Intervention / Treatment
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* Drug: Liugan Shuangjie Heji
* Drug: Shufeng Jiedu Capsule
* Drug: Oseltamivir Phosphate Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza; All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior; The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher; Aged between 18 to 65 years; Voluntary and signed informed consent. Exclusion Criteria: The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs; Routine blood WBC is greater than the upper limit of normal; Chest X-ray examination with inflammatory exudation images; With cardiovascular, liver, kidney and hematopoietic system such as severe primary disease, immunodeficiency disease, cancer, mental illness, without self-knowledge, liver and kidney function significantly abnormal liver meritorious service is more than 1.5 times higher than normal; Pregnancy, nursing mothers, and allergic constitution; Participated in clinical subjects for nearly three months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liugan Shuangjie Heji Group<br>Liugan Shuangjie Heji, take orally, 4 times a day, 100 ml each time (i.e. two doses per day), for a course of five days. | Drug: Liugan Shuangjie Heji<br> <br> |
| Active Comparator: Shufeng Jiedu Capsule Group<br>Shufeng Jiedu Capsule, take orally, 3 times a day, 4 capsules each time, for a course of five days. | Drug: Shufeng Jiedu Capsule<br> <br> |
| Active Comparator: Oseltamivir Phosphate Capsule Group<br>Oseltamivir Phosphate Capsule, take orally, 2 times a day, 75 mg each time, for a course of five days. | Drug: Oseltamivir Phosphate Capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from the medicine intake to 0.5℃ drop of body temperature |  | five days | 
| time for the body temperature to return to normal |  | five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reconciling Exterior and Interior Therapy, Influenza