A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

Influenza Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02572583
• Other study ID #: 2013BAI13B021
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 12, 2015
• Last updated: October 8, 2015
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2015
• Source: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
• Contact: Yang - Jiao, MD
• Phone: +86 13601016612
• Email: Yangjiao2013[@]sina.cn
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Liugan Shuangjie Heji

• Shufeng Jiedu Capsule

• Oseltamivir Phosphate Capsule

Locations

Country	Name	City	State
China	Dongfang Hospital affiliated to Beijing University of Chinese Medicine	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time from the medicine intake to 0.5? drop of body temperature		five days	Yes
Primary	time for the body temperature to return to normal		five days	Yes