Lingdancao Granules in the Treatment of Seasonal Influenza

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Name of study:

Randomized, Double-Blinded, Oseltamivir-and-Placebo-Controlled Clinical Study about Lingdancao Granules in the Treatment of Seasonal Influenza

Objective:

Preliminary evaluation on the efficacy and safety of Lingdancao granules in the treatment of seasonal influenza

Design:

Multicenter, randomized, double-blind, double parallel analogy, positive drug and placebo controlled trial

Case number:

This test is expected to be included in 318 cases of 14-65 (≥14 or ≤65) ages of subjects. Qualified participants are randomly divided into experimental drug group (Lingdancao granules group), positive control group (oseltamivir phosphate group) and placebo group, 106 cases in each.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• 1.1 Aged 14-65 from the outpatients who presented with influenza-like illness (ILI).ILI was defined as a sudden onset of fever (≥ 38°C) with respiratory tract symptoms and at least one of the following symptoms: muscle ache, headache, extreme fatigue or poor activity.

1.2 Confirmed infection by the influenza A or B virus or the new influenza A (H1N1) virus according to virological examination.

1.3 Acute onset within 72 hours. 1.4 Axillary temperature ≥38℃, with at least two of the following symptoms, headache, body discomfort, muscle pain, aversion to cold or cold chills, fatigue; along with either one of the respiratory symptoms from cough, sore throat and nasal symptoms.

1.5 Voluntarily signed informed consents

Exclusion Criteria:

• With one of the following are excluded from the study. 2.1 Aged <14 or >65. 2.2 Chest imaging (X-ray or CT) confirmed bronchitis, pneumonia, pleural effusion, interstitial lesions, etc.

2.3 Routine blood test when screening displayed WBC>10.0x109/L, or NEUT. ≥75%. 2.4 Patients coughing purulent sputum or with suppurative tonsillitis. 2.5 Patients with diabetes or serious underlying disease, such as blood disease, severe COPD (FEV1 / EVC < 70%, FEV1 of expected value < 50%; or respiratory failure or right heart failure), severe hepatic insufficiency (ALT or AST 3 times above normal or higher); severe renal insufficiency (serum creatinine > 2 mg/dL); chronic congestive heart failure (NYHA heart function level Ⅲ- IV), psychiatric diseases.

2.6 Have already taken antiviral drugs (amantadine, rimantadine, zanamivir and oseltamivir phosphate, etc.) or related Chinese medicine or Chinese patent medicine after the onset before the screening. Or patients have taken Choulingdan or Chinese patent medicine with Choulingdan as part of the ingredients within 1 week before the onset.

2.7 Allergic to Choulingdan or its preparations composition, to oseltamivir or its ingredients, and to drug simulation ingredients, or allergic constitution.

2.8 Women in pregnancy or lactation period, women of childbearing age with plan of a pregnancy.

2.9 Patients with immune deficiency, such as malignant tumor, organ or bone marrow transplantation and AIDS, or taking immunosuppressant in 3 months.

2.10 With dubious or confirmed alcohol and drug abuse history. 2.11 Patients that have been in a similar drug clinical study in 3 months. 2.12 Suffered from acute respiratory infection, otitis media or sinusitis 2 weeks before.

2.13 Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 mouths before.

2.14 Other reasons that researchers think not fitting to participate in the study.