Pharmaceutical standardization of Agastyahareetaki Avaleha and Agastyahareetaki Granules and their comparative efficacy in the management of Tamaka Shwasa (Bronchial Asthma)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- It is expected that the trial drugs will exert a significant action over Tamaka Shwasa (Bronchial Asthma)
研究概览
简要总结
Bronchial asthma is characterized by difficulty in breathing, cough, wheezing and chest tightness. Paroxysm attack can last for days to months. which results in handicapped day and sleepless nights, thus disturbing the normal life style of the person. It is common and prevalent worldwide, equally affecting both sexes in adult but in children male female ratio is 2:1.Asthma, being a problem worldwide, has an estimated 330 million affected individuals and causing 2,50,000 deaths annually worldwide.1India has an estimated 15-20 million asthmatics.2Epidemiological data shows increased incidence and prevalence of Tamaka Shwasa imposing large burden to health services. Based on the similarities in aetio- pathogenesis and symptomatology, this condition can be compared with Tamaka Shwasa in Ayurveda.Ayurvedic system of Indian medicine is believed to promote positive health and maintain organic resistance against infection by establishing the body’s equilibrium and conditioning the body tissues. In recent years the plant material and herbal remedies derived from them represent a sustained proportion and has gained place in the health management throughout the globe.
Conversion of formulations into various dosage forms so as to increase the palatability, shelf life etc. has gained great importance in market to meet the trend of the present era. In addition, the concept of standardization and quality control of final products is the major issue today regarding the Ayurvedic products.
With the advancement of science, it is possible to provide a scientific basis and credibility to Ayurvedic drugs through which one can make efforts to meet the standards set for globalization. Different studies make clear that rasayana inAyurveda act simultaneously on different systems viz. the nervous - endocrine - immune systems.
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
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Mild persistent cases of Bronchial Asthma with day time symptoms 3-6/week and nocturnal symptoms with 3-4/month.
- •Moderate persistence cases with daytime symptoms daily and nocturnal symptoms with one or more than one week but not more than 2 weeks.
排除标准
- •Known patients of diabetes mellitus and uncontrolled HTN.
- •Dyspnoea resulting from cardiac origin, other lung pathologies (like-lower respiratory tract infection,Chronic obstructive pulmonary disease, Emphysema, upper respiratory tract obstruction, bronchiectasis,interstitial lung disease, occupational lung disease,tropical pulmonary eosinophilia,Tuberculosis, Pulmonary malignancy, chronic pluritis, plural effusion),anaemia.
- •Age above 60 years and below 16 years.
- •Pregnant and lactating mothers.
- •Patients suffering with other types of Shwasa,i.e. Maha, Urdha, ChhinnaShwasa will be excluded from the study.
- •Febrile patients on presentation or history of fever within past one week.
结局指标
主要结局
It is expected that the trial drugs will exert a significant action over Tamaka Shwasa (Bronchial Asthma)
时间窗: 2 month
次要结局
- significant relief in the sign and symptoms of tamaka shwasa (bronchial asthama)(2 month)