Study on bioenhancer in the treatment of tuberculosis with Rifampicin : An evidencebased update - A Randomized Controlled Tial
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sputum conversion rate, improvement in lung function, chest x ray
研究概览
简要总结
Rifampicin containing fixed-dosecombinations are the currently approved treatments against TB in India and worldover. Rifampicin is a potent drug to fight TB but it has some unpleasantside-effects that often forces the patients discontinue with the medicine. Risorineis a combination of currently used antitubercular drugs isoniazid andrifampicin mixed with a new ingredient piperine (an extract of black pepper). Thecombination tablet uses only 200 mg of rifampicin instead of 450 mg, butmaintains the same efficacy and therefore reduces the need for high doses. However there is lack of evidence for Risorine in south Indian population. The present study will be an evidence based report.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient who is willing to give informed consent and sputum positive patient.
排除标准
- •Pregnant and lactating women and Patient who is unwilling to participate in the trial.
结局指标
主要结局
Sputum conversion rate, improvement in lung function, chest x ray
时间窗: one year
次要结局
- Improvement in QoL and cognitive function(6 months)
