A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02572583

Enrollment

300

Registered

2015-10-09

Start date

2014-11-30

Completion date

2016-11-30

Last updated

2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Reconciling Exterior and Interior Therapy, Influenza

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.

Interventions

DRUGLiugan Shuangjie Heji

DRUGShufeng Jiedu Capsule

DRUGOseltamivir Phosphate Capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Countries

China

Contacts

Primary ContactYang - Jiao, MD

Yangjiao2013@sina.cn+86 13601016612

Backup ContactZhisong - Wu, MD

wuzhisong1220@163.com+86 13811578627

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026