A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

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.

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Drug: Liugan Shuangjie Heji; Drug: Shufeng Jiedu Capsule; Drug: Oseltamivir Phosphate Capsule

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100078
    • Recruiting
    • Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
    • Contact: Yang Jiao, MD; Phone Number: +86 13601016612; Email: Yangjiao2013@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Liugan Shuangjie Heji
Active Comparator: Shufeng Jiedu Capsule Group; Shufeng Jiedu Capsule, take orally, 3 times a day, 4 capsules each time, for a course of five days.	Drug: Shufeng Jiedu Capsule
Active Comparator: Oseltamivir Phosphate Capsule Group; Oseltamivir Phosphate Capsule, take orally, 2 times a day, 75 mg each time, for a course of five days.	Drug: Oseltamivir Phosphate Capsule

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
• Investigators: Study Director: Yang - Jiao, MD, Dongfang Hospital Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: April 12, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Estimate): October 9, 2015
• Last Update Submitted That Met QC Criteria: October 8, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Influenza; Reconciling Exterior and Interior Therapy
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: 2013BAI13B021