CTRI/2021/11/037824尚未招募1 期
Pharmaceutical Revalidation of Shwasakuthara Rasa and its Preclinical Safety and Phase I-II Dose Determination (Safety &Efficacy) Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Phase I- Healthy volunteers of either sex, age 20-60 years, belongs from same socio-economical condition, follow same dietary regimen and life style who willing to participate in the study will be enrolled after obtaining informed consent from each volunteer.
- •Phase II- Diagnosed case of mild and moderate persistent bronchial asthma who are willing to participate in this study by giving his/her consent during the course of work, Both the sexes having age between 20 years to 60 years.
排除标准
- •Phase I-Healthy person who donâ??t want to participate, evidence of significant physical abnormalities, history of chronic medication within the past 6 weeks, history of hypersensitivity to any medication, regular smokers who smoke more than 10 cigarettes daily or have difficulty in abstaining from smoking during the study duration, history of drug dependence or chronic alcohol use, women with anticipated pregnancy/pregnant/lactating/ using oral contraceptives.
- •Phase II- Dyspnea resulting from other diseases like left ventricular failure, upper respiratory tract obstruction, bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational lung disease, tropical pulmonary eosinophilia & allergic bronchopulmonary aspergillosis etc. Patients having anemia, pneumonia, tuberculosis, lung cancer, lung abscess and other such complicated conditions, Patients having diabetes, hypertension, Chronic and Acute renal failure etc. conditions in which urination is markedly diminished or excessive will be excluded, HIV, Pregnant/ lactating mother, Patient taking conventional medication.
研究者
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