跳至主要内容
临床试验/CTRI/2015/01/005475
CTRI/2015/01/005475已完成Unknown

Study on bioenhancer in the treatment of tuberculosis with Rifampicin : An evidencebased update - A Randomized Controlled Tial

Department of Pulmonary Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月8日最近更新:

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)

研究者

发起方
Department of Pulmonary Medicine
申办方类型
Research institution and hospital

研究点 (1)

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