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Lianhuaqingwen capsule in the treatment of senile mild influenza: a prospective, randomized,double-blind,positive drug controlled trial

Lianhuaqingwen capsule in the treatment of senile mild influenza: a prospective, randomized,double-blind,positive drug controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020551
Enrollment
Unknown
Registered
2019-01-08
Start date
2019-01-10
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Influenza

Interventions

Experimental group:Take orally, Lianhuaqingwen capsule, 1 bag per time, three times per day+ analogous oseltamivir phosphate capsule, two grains at one time, two times per day
Control group:Take orally, analogous Lianhuaqingwen capsule, 1 bag per time, three times per day+ oseltamivir phosphate capsule, two grains at one time, two times per day

Sponsors

Guangdong Provincial Hospital of TCM(Second Affiliated Hospital of Guangzhou University of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnosis of mild influenza by The diagnosis and the treatment scheme of influenza(2018 edition), with being confirmed as seasonal influenza virus(A/B) by virology test, and TCM syndrome belongs to invasion of the lung by wind-heat or invasion of the lung by toxic-heat; 2. Aged from 65 to 80 year; 3. The onset time within 48 hours; 4. Axillary temperature >37.4degree C, and last 24 hours and more; 5. Voluntarily signed informed consents.

Exclusion criteria

Exclusion criteria: 1. Chest imaging (X-ray or CT) confirmed bronchitis, pneumonia,pleural effusion, interstitial lesions, etc. 2. Routine blood test when screening displayed WBC>12.0x10^9/L, or NEUT%>=80%; 3. Patients coughing purulent sputum or with suppurative tonsillitis; 4. Patients with serious underlying disease, such as blood disease, severe COPD (FEV1/EVC 2 mg/dL); chronic congestive heart failure (NYHA heart function level III-IV), psychiatric diseases; 5. Have already taken antiviral drugs (oseltamivir phosphate, amantadine, rimantadine, and zanamivir, etc.) or related Chinese medicine or Chinese patent medicine after the onset before the screening, Or patients have taken Lianhuaqingwen capsule within 1 week before the onset; 6. Allergic to Lianhuaqingwen capsule or its preparations composition, to oseltamivir phosphate or its ingredients, and to drug simulation ingredients, or allergic constitution; 7. Patients with immune deficiency,such as malignant tumor, organ or bone marrow transplantation and AIDS,or taking immunosuppressant in 3 months; 8. With dubious or confirmed alcohol and drug abuse history; 9. Patients that have been in a similar drug clinical study in 3 months; 10. Suffered from acute respiratory infection,otitis media or sinusitis 2 weeks before; 11. Having vaccination of a influenza vaccine 6 mouths before; 12. Other reasons that researchers think not fitting to participate in the study.

Design outcomes

Primary

MeasureTime frame
The time needed for defervescence from the first dose of study medication to the time when body temperature drop to normal;The time needed for alleviation of all influenza symptoms;

Secondary

MeasureTime frame
The incidence of influenza complications;The incidence of influenza severe cases;Negative rate of influenza virus;Immuno and inflammatory markers;

Contacts

Public ContactZhongde Zhang

Guangdong Provincial Hospital of TCM

doctorzzd99@163.com+86 20 81887233

Outcome results

None listed

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