A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

Phase 1

• Conditions: Influenza
• Interventions: Drug: Liugan Shuangjie Heji; Drug: Shufeng Jiedu Capsule; Drug: Oseltamivir Phosphate Capsule

• Registration Number: NCT02572583
• Lead Sponsor: Dongfang Hospital Beijing University of Chinese Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Status Verified: 2015-04
• Study First Submitted: 2015-04-12
• Study First Submitted QC: 2015-10-08
• Last Update Submitted: 2015-10-08
• Study First Posted: 2015-10-09
• Last Update Posted: 2015-10-09
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liugan Shuangjie Heji Group	Liugan Shuangjie Heji	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.
Shufeng Jiedu Capsule Group	Shufeng Jiedu Capsule	Shufeng Jiedu Capsule, take orally, 3 times a day, 4 capsules each time, for a course of five days.
Oseltamivir Phosphate Capsule Group	Oseltamivir Phosphate Capsule	Oseltamivir Phosphate Capsule, take orally, 2 times a day, 75 mg each time, for a course of five days.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dongfang Hospital affiliated to Beijing University of Chinese Medicine; 🇨🇳 Beijing, China