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临床试验/CTRI/2020/01/023000
CTRI/2020/01/023000已完成4 期

An open label, observational, practice based, non-comparative, multicenter, prospective, active surveillance to evaluate the safety and efficacy of theoasthalin/theoasthalin forte tablet in patients with reversible airflow obstruction associated with asthma and other chronic lung diseases

Cipla Ltd0 个研究点目标入组 168 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
Cipla Ltd
入组人数
168

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1. A written, signed, dated and ethics committee approved informed consent form (data sharing consent) from Patients and/or legally acceptable representatives
  • 2. Either male or female of age between 18 years and 60 years
  • 3. Patients with reversible airflow obstruction associated with asthma and other chronic lung diseases suitable to receive either theoasthalin/theoasthalin forte tablets.

排除标准

  • 1. Patients with hypersensitivity to study drugs.
  • 2. Patients with pregnancy or lactation.
  • 3. Patients with Active peptic ulcer disease.
  • 4. Patients with Seizure disorders.
  • 5. Patients with Cardiac arrhythmias.
  • 6. Concurrent diseases such as Acute pulmonary edema, Congestive heart failure, Cor pulmonale, Fever; ââ?°Â¥102 F for 24 hours or more; or lesser temperature elevations for longer periods, Hypothyroidism, Hyperthyroidism, Liver disease; cirrhosis, acute hepatitis, Sepsis with multi-organ failure, shock.
  • 7. Patients on beta-blocking drugs.
  • 8. Patients unsuitable for study as per Investigatorââ?¬•s discretion.
  • 9. Participated in clinical trial 30 days prior to screening.

研究者

发起方
Cipla Ltd

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