CTRI/2018/01/011387已完成不适用
Indian Herbal Medicine for Influenza- Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Time to improvement of symptoms:
研究概览
简要总结
Influenza is one of the most common epidemics occurring in India during winter months. Most of the commonly used antiviral have limited efficacy and safety in influenza treatment. Flu Care polyherbal consist of antiviral, antitussive and anti-inflammatory herbal medicine. If this Flu care intervention is shown to be effective, there will be major potential benefits to general population. The aim of this study is to determine the efficacy of Flu care polyherbal formulation in the management of acute uncomplicated case of Influenza within 48 hours of symptoms onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects above the age of 18 years, providing written informed consent.
- •Patients with a duration of influenza symptoms confirmed by all of the following: i.
- •Fever ≥ 38º C (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken ii.
- •At least 1 each of the following general and respiratory symptoms associated with influenza is present with a severity of moderate or greater: a.
- •Respiratory symptoms (cough, sore throat, or nasal congestion) Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
- •The time interval between the onset of symptoms and the predose examinations is 48 hours or less.
- •The onset of symptoms is defined as either: a.
- •Time of the first increase in body temperature (an increase of at least 1º C from normal body temperature) b.
- •Time when the patient experiences at least 1 new general or respiratory symptom.
排除标准
- •Patients will be considered at high risk of influenza complications due to the presence of at least 1 of the following inclusion criteria:
- •Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
- •Endocrine disorders (including diabetes mellitus)
- •Residents of long-term care facilities (e.g., nursing homes)
- •Compromised immune system
- •Neurological and neurodevelopmental disorders
- •Heart disease (Congenital heart disease, Congestive heart failure)
- •Adults aged 65 years or more
- •Blood fisorders
- •Metabolic disorders
- •Morbid Obesity (BMI more than 40) Other Exclusion criteria: Any one of the following
- •Influenza vaccination with live attenuated vaccine in the 3 months prior to randomization
- •Antiviral treatment for influenza in 2 weeks prior to randomization
- •Severe Hepatic and renal impairment
- •Pregnant, attempting to conceive, or lactating women.
结局指标
主要结局
Time to improvement of symptoms:
时间窗: Day 1 pretreatment upto Day 7
Time to improvement of symptoms is defined as the time from initiation of study treatment to improvement of influenza symptoms for a duration of at least 21.5 hours (24 hours - 10%).
时间窗: Day 1 pretreatment upto Day 7
次要结局
- Time to alleviation of symptoms:(Time to alleviation of symptoms is defined as the time between the initiation of the study treatment and the alleviation of influenza symptoms. The alleviation of influenza symptoms is defined as the time when all of 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) have been assessed by the patient.)
- Time to improvement in the 4 systemic symptoms:(Defined as the time between the initiation of the study treatment and the improvement in the 4 systemic symptoms symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue).)
- Time to improvement in the 3 respiratory symptoms:(Defined as the time between the initiation of the study treatment and the improvement in the 3 respiratory symptoms (cough, sore throat, and nasal congestion).)
- Time to resolution of fever:(Defined as the time between the initiation of the study treatment and the resolution of fever.)
- Percentage of participants with adverse events(Baseline up to Day 7)
- Percentage change in participants positive for influenza virus titer and viral RNA at end of treatment:(Defined as the percentage of patients whose virus titer and ribonucleic acid (RNA) load are become less than the lower limit of quantification among those assessed for virus titer and RNA load. RNA load is measured by reverse transcription polymerase chain reaction (RT-PCR).)
- Percentage of participants with influenza-related complications:(Defined as the percentage of patients who experience each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically-confirmed pneumonia) as an adverse event after the initiation of study treatment.)
- Percentage of participants who had been hospitalized(Baseline up to Day 7)
研究者
研究点 (3)
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