Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
研究概览
简要总结
The aim of this trial is to study the effect of a polyherbal capsule containing four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum in the treatment of bronchial asthma.
详细描述
A randomized placebo controlled double blind trial. Four herbs that have proven efficacy on bronchial asthma will be given. Equally matched placebo will be given randomly to patients. Each arm active herbs and placebo will be compared against the Formoterol+Fluticasone Single maintenance and reliever therapy(SMART) and conventional therapy. All the parameters of Bronchial Asthma(BA) will be compared between the randomized groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults aged ≥ 18 years.
- •History of asthma documented by a physician for at least 6 months
- •Patients on steroid therapy for at least 4 weeks.
- •If not on steroid therapy, patient and physician must be willing for 4 weeks run in on steroid therapy.
- •The subject agrees to participate in the study
排除标准
- •Any one of the following
- •Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
- •Abnormal hepatic and renal function
- •Pregnant, attempting to conceive, or lactating women
- •Current or former employees of organic India
- •Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
- •Physician uncomfortable with patient compliance to treatments or follow up.
- •Non-compliance to tobacco cessation therapy.
研究组 & 干预措施
Active
[Formoterol + Fluticasone] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule
干预措施: Polyherbal (Drug)
Active
[Formoterol + Fluticasone] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule
干预措施: Placebo (Drug)
Placebo
[Formoterol + Fluticasone] conventional along with inert similar looking placebo capsules
干预措施: Polyherbal (Drug)
Placebo
[Formoterol + Fluticasone] conventional along with inert similar looking placebo capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
时间窗: 6 months
Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline
时间窗: 6 months
次要结局
- Number of patients with frequency of asthma exacerbation per week(6 months)