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A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

Primary Purpose

Influenza

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Liugan Shuangjie Heji
Shufeng Jiedu Capsule
Oseltamivir Phosphate Capsule
Sponsored by
Dongfang Hospital Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring Reconciling Exterior and Interior Therapy, Influenza

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dongfang Hospital affiliated to Beijing University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Liugan Shuangjie Heji Group

Shufeng Jiedu Capsule Group

Oseltamivir Phosphate Capsule Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

time from the medicine intake to 0.5℃ drop of body temperature
time for the body temperature to return to normal

Secondary Outcome Measures

Full Information

First Posted
April 12, 2015
Last Updated
October 8, 2015
Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02572583
Brief Title
A Clinical Study of Treating Influenza With Liugan Shuangjie Heji
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dongfang Hospital Beijing University of Chinese Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Reconciling Exterior and Interior Therapy, Influenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liugan Shuangjie Heji Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Shufeng Jiedu Capsule Group
Arm Type
Active Comparator
Arm Description
Shufeng Jiedu Capsule, take orally, 3 times a day, 4 capsules each time, for a course of five days.
Arm Title
Oseltamivir Phosphate Capsule Group
Arm Type
Active Comparator
Arm Description
Oseltamivir Phosphate Capsule, take orally, 2 times a day, 75 mg each time, for a course of five days.
Intervention Type
Drug
Intervention Name(s)
Liugan Shuangjie Heji
Intervention Type
Drug
Intervention Name(s)
Shufeng Jiedu Capsule
Intervention Type
Drug
Intervention Name(s)
Oseltamivir Phosphate Capsule
Primary Outcome Measure Information:
Title
time from the medicine intake to 0.5℃ drop of body temperature
Time Frame
five days
Title
time for the body temperature to return to normal
Time Frame
five days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang - Jiao, MD
Phone
+86 13601016612
Email
Yangjiao2013@sina.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhisong - Wu, MD
Phone
+86 13811578627
Email
wuzhisong1220@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang - Jiao, MD
Organizational Affiliation
Dongfang Hospital Beijing University of Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Dongfang Hospital affiliated to Beijing University of Chinese Medicine
City
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Jiao, MD
Phone
+86 13601016612
Email
Yangjiao2013@sina.cn

12. IPD Sharing Statement

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A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

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