A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

NCT ID: NCT02572583

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-11-30

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liugan Shuangjie Heji Group

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.

Group Type: EXPERIMENTAL

Liugan Shuangjie Heji

Intervention Type: DRUG

Shufeng Jiedu Capsule Group

Shufeng Jiedu Capsule, take orally, 3 times a day, 4 capsules each time, for a course of five days.

Group Type: ACTIVE_COMPARATOR

Shufeng Jiedu Capsule

Intervention Type: DRUG

Oseltamivir Phosphate Capsule Group

Oseltamivir Phosphate Capsule, take orally, 2 times a day, 75 mg each time, for a course of five days.

Group Type: ACTIVE_COMPARATOR

Oseltamivir Phosphate Capsule

Intervention Type: DRUG

Interventions

Liugan Shuangjie Heji

Intervention Type: DRUG

Shufeng Jiedu Capsule

Intervention Type: DRUG

Oseltamivir Phosphate Capsule

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongfang Hospital Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang - Jiao, MD

Role: STUDY_DIRECTOR

Dongfang Hospital Beijing University of Chinese Medicine

Locations

Dongfang Hospital affiliated to Beijing University of Chinese Medicine

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang - Jiao, MD

Role: CONTACT

Yangjiao2013@sina.cn

+86 13601016612

Zhisong - Wu, MD

Role: CONTACT

wuzhisong1220@163.com

+86 13811578627

Facility Contacts

Yang Jiao, MD

Role: primary

Yangjiao2013@sina.cn

+86 13601016612

Other Identifiers

2013BAI13B021

Identifier Type: -

Identifier Source: org_study_id