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Status unknownNCT02572583Updated Oct 9, 2015

A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

A Phase 1/2 interventional study of Liugan Shuangjie Heji and Shufeng Jiedu Capsule in Influenza, sponsored by Dongfang Hospital Beijing University of Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-09.

Sponsored by Dongfang Hospital Beijing University of Chinese Medicine · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza

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Keywords

  • Reconciling Exterior and Interior Therapy
  • Influenza
03

In context

Influenza, Human

2,265 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's planned enrollment of 300 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Dongfang Hospital Beijing University of Chinese Medicine is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. time from the medicine intake to 0.5℃ drop of body temperature

    Time frame: five days

  2. time for the body temperature to return to normal

    Time frame: five days

07

Study locations

1 of 1 sites recruiting
  • Dongfang Hospital affiliated to Beijing University of Chinese Medicine
    Beijing, 100078, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2014, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2015
First posted
Oct 9, 2015
Start
Nov 2014
Primary completionEst.
Nov 2016
CompletionEst.
Nov 2016
Last update
Oct 9, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02572583
Lead sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Responsible party
Sponsor
First posted
Oct 9, 2015
Start date
Nov 2014
Primary completion
Nov 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Oct 9, 2015

Study contacts

Yang - Jiao, MD
Contact
Yangjiao2013@sina.cn
+86 13601016612
Zhisong - Wu, MD
Contact
wuzhisong1220@163.com
+86 13811578627
Yang - Jiao, MD
study director · Dongfang Hospital Beijing University of Chinese Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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