跳至主要内容
临床试验/CTRI/2024/07/070039
CTRI/2024/07/070039尚未招募4 期

An Open labelled Randomised Control Trial to compare the efficacy and safety of Benzonatate and Levodropropizine in the treatment of chronic refractory cough in ILD patients

Dr Naveen Dutt1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年7月12日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
56
试验地点
1
主要终点
Efficacy of Benzonatate and Levodropropizine in treatment of chronic refractory cough in ILD Patients using Leicester Cough Questionnaire

研究概览

简要总结

This study is a open labelled randomised control trial to compare the efficacy and safety of benzonatate and levodropropizine in treatment of chronic refractory cough in ILD ppatients . study will be conducted in AIIMS JODHPUR .Objectives of the study are to assess the efficacy of Benzonatate and Levodropropizine in treatment of chronic refractory cough in ILD Patients using Leicester Cough Questionnaire ,Cough VAS score ,To check the safety profile of Benzonatate  and Levodropropizine therapy ,to identify the factors affecting the outcome of therapy .Patient who are >18 years with diagnosed case of ILD with Cough VAS score of 

40mm if their giving consent ,will be included in the study .Pregnant and lactating woman , active smokers , severly ill patients,with the history of arrythmia and cardiac illness ,with other causes of cough ,and those who are taking any other traditional treatment remedies will be excluded from the study.ILD patient with chronic refractory cough attending pulmonary medicine OPD will be enrolled in the study ,once inclusion and exclusion criteria has fulfilled . patients will be randomised to 2 groups will be done with a computer generated sequence . One group will receive benzonatate capsule 100 mg TDS and the other group will get Levodropropizine syrup 10 ML TDS . we will compare the effectiveness with the help of various cough scores like LCQ ,Cough VAS and adverse effects will be noted.Sample size is 56 and 23 in each group .outcome will be asessed at 2 weeks and 4 weeks .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18 year and older 2.Consenting to participate in the study 3.Radiologically or histopathologically diagnosed ILD 4.Those with chronic refractory cough 5.Patient taking same baseline treatment for ILD for last 2 weeks.

排除标准

  • 1.Cognitively impaired patient 2.Pregnant or lactating female 3.Not willing to participate in study 4.Severely ill patients 5.Known hypersensitivity to local anesthetic 6.Other treatable causes of cough
  • Active smoker 8.Already taking cough medications.

结局指标

主要结局

Efficacy of Benzonatate and Levodropropizine in treatment of chronic refractory cough in ILD Patients using Leicester Cough Questionnaire

时间窗: 2 Week and 4 week

次要结局

  • 1. To assess the efficacy of Benzonatate & Levodropropizine in symptomatic relief of chronic refractory cough in ILD Patients using cough VAS score.(2. To check the safety profile of Benzonatate & Levodropropizine therapy.)

研究者

发起方
Dr Naveen Dutt
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Naveen Dutt

AIIMS Jodhpur

研究点 (1)

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