A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine; Dongfang Hospital Beijing University of Chinese Medicine
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

1. The disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza;

2. All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior;

3. The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher;

4. Aged between 18 to 65 years;

5. Voluntary and signed informed consent.

Exclusion Criteria:

1. The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs;

2. Routine blood WBC is greater than the upper limit of normal;

3. Chest X-ray examination with inflammatory exudation images;

4. 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;

5. Pregnancy, nursing mothers, and allergic constitution;

6. Participated in clinical subjects for nearly three months.