A PROSPECTIVE OPEN LABELLED ,SINGLE ARM,NON-RANDOMIZED SINGLE CENTRIC PHASE II CLINICAL EVALUATION OF NARUVILI CHOORANAM IN THE MANAGEMENT OF IRAIPPU NOI (BRONCHIAL ASTHMA)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 3.Dyspnoea
研究概览
简要总结
This study is a Prospective Open Labelled Phase II non randomized clinical study to evaluate the therapeutic efficacy of NARUVILI CHOORANAM in the management of IRAIPPU NOI (BRONCHIAL ASTHMA) .The trial drug will be administered at the dose of 5 gram /twice a day (orally with hot water) 45 days in 40 patients.The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli,Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug NARUVILI CHOORANAM . The secondary outcome will be the evaluation of Siddha Diagnostic Parameters,assessments of safety profile of trial drug,assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.More than 30 and less than 60 years 2.Patient with the symptoms of dry cough,recurrent attacks of dyspnoea,hoarseness of voice,tightness of the chest,profuse sweating and wheezing 3.History of allergens,climatic changes 4.Patients who are willing to take radiological investigations & provide blood for lab investigations.
排除标准
- •1.Below 29 and above 60 years 2.Cardiac diseases 3.Chronic allergic bronchitis 4.Tuberculosis 4.COPD 5.Pregnancy and Lactating mothers 6.Status Asthmaticus 7.Systemic Hypertension 8.Autoimmune diseases 9.Drugs and chemicals.
结局指标
主要结局
3.Dyspnoea
时间窗: 45 days
1.Tightness of the chest
时间窗: 45 days
If during treatment or after treatment reduction of the following symptoms:
时间窗: 45 days
4.Difficulty in both inspiration and Expiration
时间窗: 45 days
2.Wheezing
时间窗: 45 days
次要结局
- 1.Comparing the pre and post treatment of Peak Expiratory Flow rate(2.Comparing the following parameters before and after treatment.)