A randomized, double blind placebo controlled, clinical study of one RespicorÂ® product against Asthma in human subjects.

aila Impex RnD centre0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Participants must understand the risks and benefits of the protocol.
•Age range of 21 - 60 years having mild to moderate asthma (male or female, with a diagnosis of asthma for at least one year.)
•Observed symptoms of bronchial asthma (dyspnoea, wheezing, tightness in chest, cough etc.)
•Subjects with mild to moderate obstruction on PFT with significant bronchio reversibility.
•Subjects with mild to moderate with significant bronchio reversibility and clinically stable.
•Chest radiograph without evidence of pulmonary disease, other than asthma.
•Forced expiratory volume in 1 second (FEV1) had to be >70% of the predicted value (after withholding Î² agonist for >6 hours) at the pre-study visit and to improve by >15% (absolute value) after inhaled Î² agonist.
•Ability to provide informed consent, as evidenced by signing a copy of the consent form approved by the Institutional Review Board.
•Moderate asthma is defined as follows(summarized from the National Asthma Education Program Expert Panel Report, USPHS Publication No. 91-304, p. 71-86)
•Moderate asthma is characterized by symptoms poorly regulated by episodic administration of a Î²2 agonist. Included in this category is asthma causing frequent symptomatic exacerbations (more than twice a week, at night, or with ordinary activities).

•Severe bronchial asthma (Peak Expiratory flow rate (PEFR) 20% and Forced Expiratory volume in 1 second (FEV1) 20% of predicted value).
•Pregnant and Lactating women, subjects having chronic bronchitis and/or emphysema, or subjects suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, cardiovascular disorders or breathlessness due to cardiovascular disorders, hepatic dysfunction, neurological disorders and diarrhoeal disorders.
•Respiratory tract infection and other serious medical illnesses in addition to asthma.
•History of lung disease other than asthma (i.e., COPD, sarcoidosis).
•History of diabetes mellitus, insulin secreting tumor, or symptomatic hypoglycemia.
•HIV or other known immunodeficiency.
•Pre existing edema (2-plus or greater).
•Hemoglobin less than 12 gm/dl for males and less than 11 gm/dl for females.
•History of liver disease or abnormal liver function tests greater than 2 X upper limit of normal.
•History of drug or alcohol abuse.
•Subjects must be non-smokers of cigarettes, pipes or cigars.

发起方

aila Impex RnD centre