A Clinical Randomised Control Study On Efficacy Of “Kiratadi Kwath†In Tamak Shvasa With Special Reference To 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
- 1)To evaluate the efficacy of Kiratadi Kwath in the management of Tamak Shvasa
研究概览
简要总结
Bronchial asthma is a disease of airways that ischaracterized by increased hyper responsiveness of the trachea-bronchial treeto many of external stimuli. Bronchial asthma is a recurrent episodic diseaseof the airways that causes wheezing, shortness of breath; cough [particularlyat night or early in morning]. In Ayurveda, Bronchial asthma is co-related withTamaka Shvasa.
This project entitled “A Clinical Randomised Control Studyon Efficacy of “Kiratadi Kwath†in Tamak Shvasa With Special Reference toBronchial Asthma.â€
All parameters and assessments will be based on signs andsymptoms of Tamak Shvasa, PEFR and SMI.
Patients fulfilling inclusive criteria will be selected andrandomisation done by computational random number generator. All these patientswill be divided in two groups called as trial and control groupby lottery methodfollowed by filling of consent form. All parameters will be assessed before andafter treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having sign and symptoms of tamak shvasa according to classics. 2) Patient showing symptoms, sign and medical history of bronchial asthma will be included. 3) Patients having respiratory rate in between 22 to 42 per minute will be included. 4) Patients suffering from this disease since 1 to 4 years will be included in study. 5) Patient with mild to moderate exacerbation of Bronchial asthma 6)patient willing and able to participate for 2 months. 7) Positive test of reversibility: a] symptomatic patients.
- •An improvement of 60 L/min or >20% in PEFR 10 min after inhalation of bronchodilator. b] Asymptomatic patient 60 L/min or >20% fall in PEFR by provocation with 5-10 min of physical exercise followed by reversal upon inhalation of bronchodilator when assessed after 10 min.
排除标准
- •Patients having major diseases like AIDS, renal and cardio vascular diseases will be rejected.
- •If any patient discontinues the treatment will be excluded from this study.
- •Patients with severe asthma exacerbation.
- •Patient who is pregnant or lactating will be excluded.
- •Patients with poorly controlled Hypertension [ >160/100mmhg] 6) Patients with uncontrolled Diabetes Mellitus [ Blood sugar fasting > 130 mg / dl and post meal 250 mg / dl] 7) Patients with active lung disease other than Bronchial asthma.
- •Patients who had major surgery within 2 weeks prior to screening visited.
- •Patients with a known diagnosis of human immunodeficiency virus.
- •Patients with evidence of malignancy.
结局指标
主要结局
1)To evaluate the efficacy of Kiratadi Kwath in the management of Tamak Shvasa
时间窗: 1)On zero day assessments i.e B.T value. | 2)For trial group Kiratadi Kwath and for control group tablet Deriphylline will be given for 45 days. | 3)followed up and assessments will be done every 15 days. | 4)Final assessment will be done on 45th day.
2) To compare the effect of Kiratadi Kwath in trial group with Tablet Deriphylline 150 mg
时间窗: 1)On zero day assessments i.e B.T value. | 2)For trial group Kiratadi Kwath and for control group tablet Deriphylline will be given for 45 days. | 3)followed up and assessments will be done every 15 days. | 4)Final assessment will be done on 45th day.
in control group.
时间窗: 1)On zero day assessments i.e B.T value. | 2)For trial group Kiratadi Kwath and for control group tablet Deriphylline will be given for 45 days. | 3)followed up and assessments will be done every 15 days. | 4)Final assessment will be done on 45th day.
specifically on PEFR, SMI.
时间窗: 1)On zero day assessments i.e B.T value. | 2)For trial group Kiratadi Kwath and for control group tablet Deriphylline will be given for 45 days. | 3)followed up and assessments will be done every 15 days. | 4)Final assessment will be done on 45th day.
次要结局
- 1)To study Tamak Shvasa in detail from Ayurvedic perspective.(2)To study Tamak Shvasa which is correlated with Bronchial asthma with modern point of view.)