CTRI/2017/09/009643已完成4 期
A Phase IV , Randomized, Open Label, multicentre study to confirm the safety and tolerability of Alerfix Total (Levocetirizine, Montelukast, Ambroxol) in patients with Non specific respiratory symptoms (NSRS) with Asthma.
Eris Life sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Men or Women, between 18 to 80 years of age (both inclusive).
- •2.The patient experiencing Cough and/or wheeze and/or chronic dyspnoea or any other symptoms of NSRS with asthma
- •3.Patient indication and disease condition according to the â??INDICATION & USAGEâ?? as mentioned in the package insert available with Alerfix Total
- •4.Women of childbearing potential using an acceptable method of birth control.
- •5.Willing to give written informed consent for participation in the study and to comply with the study procedures
排除标准
- •1.Evidence of active liver disease or SGPT > 2.5 times upper limit of normal (ULN)
- •2.Evidence of renal impairment (Serum creatinine levels more than 2.0 mg /dl)
- •3.Pregnancy
- •4.Malignancy
- •5.Contraindication as mentioned in package insert
- •6.Patients with medical conditions that preclude the follow-up as defined in the protocol or otherwise limits participation in this study
- •7.Patients with known history of hypersensitivity to the study drug
研究者
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