A Prospective Open-labelled, Non-Randomized, Phase -II Clinical trial of Kanduparangi Chooranam in the management of Iya 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
- 60
- 试验地点
- 1
- 主要终点
- If during treatment or after treatment reduction of the following symptoms
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 Kanduparangi Chooranam in the management of Iya Iraippu Noi( Bronchial Asthma).The trial drug will be administered at the dose of 60 mg/ Kg /BW/Twice a day A/F 30 days along with honey as adjuvant in 60 patients (30 in OPD and 30 in IPD).The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Palayamkottai Tirunelvelli Tamilnadu. The primary outcome will be evaluation of therapuetic efficacy of trial drug Kanduparangi Chooranam. The secondary outcome will be the evaluation 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 event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI.Further management of patient 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
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with the symptoms of dry cough, recurrent attacks of dyspnoea,hoarseness of voice,frequent hemming,tightness of chest, profuse sweating & wheezing 2)H/o allergens, sneezing. 3)Patients who are willing to take radiological investigation and provide blood for lab investigation. 4)Patients who are willing to estimate volume of air forcibly expired after a deep inspiration by using Mini-Peak flow meter and PEFR below normal range from 250L/min to 150 l/min for men, from 200L/min to 100 L/min for women, for those patients are included. 7)Patients who are willing to do Spirometer study.
- •To estimate Pulmonary Function Test (PFT).
排除标准
- •Pregancy 2)Lactating mother 3)Cardiac disease 4)Renal disease 5)Tuberculosis 6)Chronic bronchitis 7)Status asthmaticus 8)Diabetes mellitus 9)Auto immune disease.
结局指标
主要结局
If during treatment or after treatment reduction of the following symptoms
时间窗: 30 days
1.Dry cough
时间窗: 30 days
2.Recurrent attacks of dyspnoea
时间窗: 30 days
5.Tightness of chest
时间窗: 30 days
7.Wheezing.
时间窗: 30 days
3.Hoarseness of voice
时间窗: 30 days
4.Frequent hemming
时间窗: 30 days
6.Profuse sweating
时间窗: 30 days
次要结局
- 1.Evaluation of physicochemical, phyto chemical, bio chemical, pharmacological activities of “Kanduparangi Chooranamâ€.(2.Evaluation of siddha parameters (including Envagai thervu)changes in “IYA IRAIPPU NOI †during trial period.)