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Efficacy and safety of Oseltamivirphosphate versus Liu Gan Shuang Jie Granule in treatment of the influenza: a multicentre, double-blind, randomized controlled trial

TCM syndrome differentiation and treatment protocol and clinical application study for influenza

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12004849
Enrollment
Unknown
Registered
2012-04-15
Start date
2014-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

influenza

Interventions

experimental group:Traditional Chinese Medicine therapy(Liu Gan Shuan
control group:Oseltamivirphosphate and Chinese herb simulation granule(Liu Gan Shuang Jie Granule)

Sponsors

Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Influenza epidemic season, acute onset, with typical influenza manifestation such as fever, cough, and/or pharyngalgiapositive result of influenza virus antigen detection (by immunofluorescence or colloidal gold method); 2. In accordance with either Wei fen-qi fen involved syndrome or qi fen heat syndrome; 3. Both body temperature=38.0? before seeing a doctor and treatment; 4. Duration is not over 36 hours; 5. Male or female, aged 18-65 years old; 6. Medical informed consent, and volunteer to participate in the research, and agree to stay more than 3 days in hospital.

Exclusion criteria

Exclusion criteria: 1. Although the duration is not over 36 hours, the patient has taken relevant medicine, such as antibiotics, antiviral drugs, glucocorticoid drugs, antipyretic analgesics, and other drugs marked in instructions for influenza; 2. Other severe upper respiratory tract infection, such as SARS, or lower respiratory tract infection, or pulmonary infection, or other fever caused by digestive, urinary, and blood system infection; 3. Severe lung disease (such as asthma, chronic bronchitis, pulmonary tuberculosis,etc.), primary cardiovascular diseases, liver diseases, kidney diseases, blood diseases, or serious diseases that influence the patient's life, such as cancer or AIDS; 4. Existence of immunodeficiency or immunosuppression, such as AIDS, malignant tumor, organ transplantation; or intake of immunosuppressants or glucocorticoids in recent 3 months; 5. pregnant, lactation period women; 6. The patient cannot cooperate or psychiatric patients.

Design outcomes

Primary

MeasureTime frame
duration time;Body temperature recovery tim;

Secondary

MeasureTime frame
virus negative conversion rate;complication rate;temperature reducing time;severity of diseas;

Countries

China

Contacts

Public ContactWu Mianhua

Nanjing University of Chinese Medicine

yefang973@163.com+86 025-85811117

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026