CTRI/2019/08/020762已完成2 期
Microbial origin mitochondria-targeted nutraceutical therapy in progressive respiratory diseases
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSIR
- 试验地点
- 1
- 主要终点
- The primary outcome of this program is at least one drug candidate (new or repurposed) at an advanced level of development (efficacy in human trial or large animal). The program will also build capacity and enhance scientific understanding of respiratory diseases.
研究概览
简要总结
PQQ has been shown to stimulate mammalian mitochondrial biogenesis via a PGC1-alpha dependent pathway. A number of preclinical studies have now found benefits of PQQ in disease models, where mitochondrial dysfunction is known to contribute. By administering this agent, we hope to reduce the rate of decline in lung function in COPD and ILD, which are otherwise relentlessly progressive
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients with a clinical and / or radiological diagnosis of COPD and ILD in the Pulmonary medicine OPD and clinics.
- •â€¢Definition of COPD: (a common preventable and treatable disease characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases.
- •Exacerbations and comorbidities contribute to the overall severity in individual patients).
- •Classification of severity will be done based on GOLD 2018 criteria using spirometry according to ATS / ERS recommendations (2005).
- •â€¢Definition of ILD: (patients with diagnosis of ILD based on clinical features, spirometry and radiological (HRCT chest) basis.
- •All types of ILD will be included.
- •Adult subjects.
排除标准
- •Patients other diseases such as lung cancer or pulmonary tuberculosis will be excluded from this study.
- •Pregnant women will be excluded from this study.
- •Patients not willing to give consent will be excluded.
结局指标
主要结局
The primary outcome of this program is at least one drug candidate (new or repurposed) at an advanced level of development (efficacy in human trial or large animal). The program will also build capacity and enhance scientific understanding of respiratory diseases.
时间窗: 6 months
次要结局
- Upon successful completion of the project, give a potential therapeutics for respiratory disease like COPD and IPF.(6 months)
研究者
研究点 (1)
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