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A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

D

Dongfang Hospital Beijing University of Chinese Medicine

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Influenza

Treatments

Drug: Shufeng Jiedu Capsule
Drug: Liugan Shuangjie Heji
Drug: Oseltamivir Phosphate Capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT02572583
2013BAI13B021

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Zhisong - Wu, MD; Yang - Jiao, MD

Data sourced from clinicaltrials.gov

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