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临床试验/CTRI/2024/11/077107
CTRI/2024/11/077107尚未招募不适用

Study Of Post Tuberculosis Lung Disease In Adults With Drug Sensitive Pulmonary Tuberculosis.

Dr Rohit Raj1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Proportion Of patients of Drug Sensitive Pulmonary Tuberculosis who develop PTLD at the completion of Treatment.

研究概览

简要总结

India accounts for more than two third of global TB patients count.With the  advancement in Medical Sciences we are able to came with the ways of early diagnosis and effective treatment of the same but its not the end game.The burden and damaging impact of post TB sequelae is also continuously rising especially in the case of Pulmonary tuberculosis. Post-TB lung disease(PTLD) has been overlooked as a significant cause of chronic lung disease. PTLD is defined as "Evidence of Chronic Respiratory Abnormality, with or without symptoms, attributable at least in part to previous pulmonary tuberculosis. It is a hetrogeneous condition which includes Airway,parenchyma, pleura and pulmonary vascular abnormalities.

In this trial we are studying the patients who was diagnosed and treated for Drug Sensitive Pulmonary Tuberculosis as per NTEP guidelines at the completion of treatment (preferably within 2-4wks ). We are looking for any related clinical complaints or symptoms that persists or develops even after the completion of ATT such as Cough, Sputum, Wheeze, Chest pain, Haemoptysis and fatigue. We are also doing CECT chest to look for any structural abnormality of lung such as Bronchiectasis, Cavitation, fibrosis,pleural thickening and bronchiolitis. We are assessing them with Spirometry for FEV1/FVC ratio to look for any obstructive or restrictive pattern. Transthoracic echo is also planned to look for Pulmonary Arterial Hypertension.

These Clinical, Radiological and Functional parameters will be evaluated at the end of study and the result will be published accordingly.

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

  • ADULTS BETWEEN 18-65 YEARS OF AGE WHO COMPLETED DAILY DRUG REGIMEN FOR DRUG SENSITIVE PULMONARY TUBERCULOSIS AS PER NTEP GUIDELINES.

排除标准

  • PATIENTS with previously Diagnosed chronic lung pathology like COPD, Asthma,ILD,PAH and Extra pulmonary Tuberculosis.

结局指标

主要结局

Proportion Of patients of Drug Sensitive Pulmonary Tuberculosis who develop PTLD at the completion of Treatment.

时间窗: Proportion Of patients of Drug Sensitive Pulmonary Tuberculosis who develop PTLD at the completion of Treatment.

次要结局

  • Clinico-Radiological and Functional Outcomes of Drug Sensitive Pulmonary Tuberculosis in Adults as per NTEP guidelines at the completion of treatment.(After completion of treatment as per NTEP guidelines.)

研究者

发起方
Dr Rohit Raj
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rohit Raj

Maulana Azad Medical College

研究点 (1)

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