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The efficacy of Gabapentin in chronic refractory cough in Interstitial Lung Disease

Phase 3
Conditions
Health Condition 1: J849- Interstitial pulmonary disease, unspecified
Registration Number
CTRI/2024/07/071040
Lead Sponsor
one
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients aged 18 years to 70 years of age. Individuals classified with interstitial lung disease according to the most recent diagnostic criteria established by the American Thoracic Society. Patients with chronic intractable cough, that is cough more than eight weeks with a severity of more than 40mm on VAS score. Patients with no contraindications to Gabapentin treatment

Exclusion Criteria

Patients who give negative informed consent. Patients with exposure to Gabapentin or Pregabalin within 2 months. Upper respiratory tract infection within 2 months. Current or ex-smokers. Patients presenting with acute exacerbation of ILD. Patients with co-morbidities like Obstructive airway disease, Gastroesophageal reflux disease or Congestive Cardiac Failure.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean LCQ scores in study group and control groupTimepoint: Baseline, 4, 8 and 12 weeks
Secondary Outcome Measures
NameTimeMethod
1. Cough severity score (VAS SCORE) in study group and control group <br/ ><br>2. Modified Borg‘s Dyspnea score in the study group and control group <br/ ><br>3. Occurrence of adverse events (AE) / Severe adverse events (SAE) <br/ ><br>4. After discontinuation of Gabapentin, change in LCQ and VAS score after 4 weeks.Timepoint: Baseline, 4, 8 and 12 weeks
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