NCT02572583

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 9, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

April 12, 2015

Last Update Submit

October 8, 2015

Conditions

Influenza

Keywords

Reconciling Exterior and Interior TherapyInfluenza

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Liugan Shuangjie Heji Group

EXPERIMENTAL

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

Shufeng Jiedu Capsule Group

ACTIVE COMPARATOR

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

Drug: Shufeng Jiedu Capsule

Oseltamivir Phosphate Capsule Group

ACTIVE COMPARATOR

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

Drug: Oseltamivir Phosphate Capsule

Interventions

Liugan Shuangjie HejiDRUG
Liugan Shuangjie Heji Group
Shufeng Jiedu CapsuleDRUG
Shufeng Jiedu Capsule Group
Oseltamivir Phosphate CapsuleDRUG
Oseltamivir Phosphate Capsule Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza;
  • All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior;
  • The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher;
  • Aged between 18 to 65 years;
  • Voluntary and signed informed consent.

You may not qualify if:

  • The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs;
  • Routine blood WBC is greater than the upper limit of normal;
  • Chest X-ray examination with inflammatory exudation images;
  • 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;
  • Pregnancy, nursing mothers, and allergic constitution;
  • Participated in clinical subjects for nearly three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongfang Hospital affiliated to Beijing University of Chinese Medicine

Beijing, 100078, China

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

shufeng jieduOseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Yang - Jiao, MD

    Dongfang Hospital Beijing University of Chinese Medicine

    STUDY DIRECTOR

Central Study Contacts

Yang - Jiao, MD

CONTACT

+86 13601016612Yangjiao2013@sina.cn

Zhisong - Wu, MD

CONTACT

+86 13811578627wuzhisong1220@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2015

First Posted

October 9, 2015

Study Start

November 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 9, 2015

Record last verified: 2015-04

Locations

CN(1)