CTRI/2020/05/025374已完成3 期
A Prospective, Interventional, Double-blind, Randomized, Placebo-Controlled Parallel Group Clinical Study to evaluate the safety and efficacy of Serracor-NK® and Serra Rx260 on improving symptoms and quality of life in patients with idiopathic pulmonary fibrosis - ICBio/CR/AETL/0104/105
Advanced Enzyme Technologies Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- •1 Clinical diagnosis of Idiopathic pulmonary fibrosis (IPF) within the last 3 years from screening based upon the American Thoracic Society/ European Respiratory Society Consensus Statement.
- •2 Male or female patients aged more than 18 years at screening.
- •3 Forced vital capacity (FVC) more than 50% of predicted normal.
- •4 Given written informed consent to participate in the study.
排除标准
- •1 Patients with HRCT Pattern of Probable / Indeterminate for UIP
- •2 Patients currently on Extracorporeal Membrane Oxygenation
- •3 Patients with acute IPF exacerbation or any respiratory tract infection within the four weeks prior to the screening period;
- •4 Alanine transaminase (ALT), Aspartate aminotransferase (AST) more than 1.5-fold upper limit of normal (ULN)
- •5 Total bilirubin more than 1.5-fold ULN
- •6 Relevant airways obstruction pre-bronchodilator Forced expiratory volume in 1 second / Forced vital capacity less than 0.70
- •7 History of Acute Coronary Syndrome
- •8 Subjects on herbal or mineral preparations for the treatment of IPF.
- •9 Pneumonia diagnoses by High-resolution computed tomography (HRCT) will be performed at the time of screening.
- •10 Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery;
- •11 A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial;
- •12 Alcohol or drug abuse which in the opinion of the treating physician would interfere with the treatment and would affect patientâ??s ability to participate in this trial;
- •13 Patients not able to understand and follow any study procedures such as but not limited to home spirometry, including completion of self-administered questionnaires without help;
- •14 Women who are pregnant, nursing, who plan to become pregnant while in the trial;
- •15 Women of childbearing potential not willing or able to use highly effective methods of birth control.
- •16 Patients who are or have been participating in another trial with investigational drugs within one month prior to screening
研究者
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