Randomized, Double-Blinded, Oseltamivir-and-Placebo-Controlled Clinical Study About Lingdancao Granules in the Treatment of Seasonal Influenza
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 318
- 主要终点
- The time needed for alleviation of all influenza symptoms
研究概览
简要总结
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.
详细描述
Study Objectives This study wishes to evaluate the efficacy and safety of Lingdancao granules for the treatment of seasonal influenza (including seasonal influenza A/H1N1 and A/H3N2 type, the new influenza A (H1N1) or influenza B) and an economic analysis on drugs in an evidence-based clinical trial with Oseltamivir phosphate Capsules and placebo as contrast.
Design and Trial registration This clinical study is a multicentered, randomized, double-blind, double control trial that testes drugs and placebo. Non-inferiority (vs. positive control) and superiority (vs. placebo control) trials are conducted.
After clinical ethics approval and before the participants' randomly enrolment, the research plan is registered both in clinicaltrials.gov and in the center of Chinese clinical trial.
Study participants
1 Designed case number of participants The study is designed to enroll 360 411 cases of patients (male and female) suffering seasonal influenza (including seasonal influenza type A/H1N1 and A/H3N2, the new influenza A (H1N1) or influenza B) aged 14-65 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •With one of the following are excluded from the study. 2.1 Aged <14 or >
- •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.
研究组 & 干预措施
Drugs for experimental group
Lingdancao granules, 4 packs per time (3g/pack), three times per day; analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day.Drugs must be used on the day of fever and last for five days continuously.
干预措施: Lingdancao granules (Drug)
Drugs for experimental group
Lingdancao granules, 4 packs per time (3g/pack), three times per day; analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day.Drugs must be used on the day of fever and last for five days continuously.
干预措施: analogous oseltamivir phosphate capsule (Drug)
Drugs for positive control group
Oseltamivir phosphate capsule (tamiflu), 1 capsule per time (75mg), twice per day; analogous Lingdancao granules, 4 packs per time, three times per day.Drugs must be used on the day of fever and last for five days continuously.
干预措施: Oseltamivir phosphate capsule (Drug)
Drugs for positive control group
Oseltamivir phosphate capsule (tamiflu), 1 capsule per time (75mg), twice per day; analogous Lingdancao granules, 4 packs per time, three times per day.Drugs must be used on the day of fever and last for five days continuously.
干预措施: analogous Lingdancao granules (Drug)
Drugs for placebo control group
Analogous Lingdancao granules, 4 packs per time, three times per day, analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day.Drugs must be used on the day of fever and last for five days continuously.
干预措施: analogous oseltamivir phosphate capsule (Drug)
Drugs for placebo control group
Analogous Lingdancao granules, 4 packs per time, three times per day, analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day.Drugs must be used on the day of fever and last for five days continuously.
干预措施: analogous Lingdancao granules (Drug)
结局指标
主要结局
The time needed for alleviation of all influenza symptoms
时间窗: Up to 30 days
fever,nasal obstruction, running nose, sore throat, cough, myalgia, fatigue, headache, aversion to cold and sweating
次要结局
- Total Area Under Curve scores of influenza-like symptoms other than fever(Up to 30 days)
- Time to return to normal states of health and activity(Up to 30 days)
- Duration of viral shedding (days)(Up to 30 days)
- The frequency of symptomatic treatment(Up to 30 days)
- The time of body temperature drop to normal(Up to 30 days)
- The incidence of influenza complications(Up to 30 days)
研究者
Hongxia Ma
Professor
The First Affiliated Hospital of Guangzhou Medical University