CTRI/2016/10/007376招募中不适用
Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1. Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
研究概览
简要总结
Herbal therapy is the third most popular choice of adults suffering from asthma among complementary and alternative therapy.
The aim of this trial is to study the effect of a poly herbal capsule containing fours herbs: Inula racemosa, Ocimum sanctum, Terminalia belerica and Piperum longum in the treatment of bronchial asthma.
Herbal therapy will be used as add on therapy to the standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
1. Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
时间窗: 6 months
2. Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline
时间窗: 6 months
次要结局
- Frequency of asthma exacerbation per week(6 months)
研究者
研究点 (2)
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