Indian Herbal Medicine for Influenza - Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to improvement of symptoms
研究概览
简要总结
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.
详细描述
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.
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
- None
盲法说明
Open label study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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:
- •Fever ≥ 38º C (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken
- •At least 1 each of the following general and respiratory symptoms associated with influenza is present with a severity of moderate or greater: i. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue) ii. 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:
- •Time of the first increase in body temperature (an increase of at least 1º C from normal body temperature)
- •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 (including patients receiving corticosteroids not exceeding 20 mg of prednisolone or equivalent, and patients being treated for human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 count > 350 cells/mm³ within the last 6 months)
- •Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, e.g., cerebral palsy, epilepsy [seizure disorders], stroke, muscular dystrophy, or spinal cord injury)
- •Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms
- •Adults aged ≥ 65 years
- •Blood disorders (such as sickle cell disease)
- •Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
- •Morbid obesity (body mass index ≥ 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
研究组 & 干预措施
Intervention Group
Each Flu Care capsule consists of combination of seven polyherbal formulation (350 mg). Participant will be instructed to take one capsule thrice daily at a fixed time in the day for the study duration of 7 days along with 75 mg of Oseltamivir.
干预措施: polyherbal formulation (Drug)
Intervention Group
Each Flu Care capsule consists of combination of seven polyherbal formulation (350 mg). Participant will be instructed to take one capsule thrice daily at a fixed time in the day for the study duration of 7 days along with 75 mg of Oseltamivir.
干预措施: Oseltamivir 75mg (Drug)
Standard Care Group
Standard of care consist of 75 mg of Oseltamivir for five days and any other required provision of care. These will be determined on case by case basis by research clinician.
干预措施: Oseltamivir 75mg (Drug)
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%).
次要结局
- Time to alleviation of symptoms(Day 1 pretreatment up to Day 7)
- Time to improvement in the 4 systemic symptoms(Day 1 pretreatment up to Day 7)
- Time to resolution of fever(Day 1 pretreatment up to Day 7)
- Percentage of participants who had been hospitalized(Baseline up to Day 7)
- Percentage change in participants positive for influenza virus titer and viral RNA at end of treatment(7 days)
- Time to improvement in the 3 respiratory symptoms(Day 1 pretreatment up to Day 7)
- Percentage of participants with influenza-related complications(Baseline up to Day 7)
- Percentage of participants with adverse events(Baseline up to Day 7)