A Prospective Open labelled non randomized phase II clinical study on KUPPAIMENI CHOORANAM in the management of IRAIPPU IRUMAL(BRONCHIAL ASTHMA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2.Recurrent attacks of dyspnoea
研究概览
简要总结
The study is a Prospective Open labelled phase II non randomized clinical study to evaluate the therapeutic efficacy of KUPPAIMENI CHOORANAM in the management of IRAIPPU IRUMAL (BRONCHIAL ASTHMA). The trial drug will be administered at the dose of 30mg/Kg/BW /twice a day(orally) A/F 45 days along with Hot water as adjuvant in 60 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 evaluation of therapeutic efficacy of trial drug KUPPAIMENI CHOORANAM. The secondary outcome will be the evaluations of Siddha diagnostic parameters, assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of 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.Patient with the symptoms of dry cough, recurrent attacks of dyspnoea,hoarseness of voice,tightness of chest,profuse sweating and wheezing 2.History of allergens, climatic changes 3.Patients who are willing to take radiological investigation and provide blood for lab investigation.
排除标准
- •1.Cardiac Diseases 2.Chronic allergic bronchitis 3.Tuberculosis 4.COPD 5.Pregnancy and Lactating mother 6.Restrictive airway disease 7.Status Asthmaticus 8.Systemic Hypertension 9.Autoimmune Diseases 10.Drugs and Chemicals.
结局指标
主要结局
2.Recurrent attacks of dyspnoea
时间窗: 45 days
6.Wheezing
时间窗: 45 days
If during treatment or after treatment reduction of the following symptoms
时间窗: 45 days
1.Dry cough
时间窗: 45 days
3.Hoarseness of voice
时间窗: 45 days
4.Tightness of chest
时间窗: 45 days
5.Profuse sweating
时间窗: 45 days
次要结局
- 1.To evaluate the pharmacological activities(2.Study about the prevalence of Iraippu Irumal in relation between diet and life styles)