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OpenTrials
Completed

NCT Number: NCT05129761

Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice

A cough is one of the most common medical complaints accounting for as many as 30 million clinical visits per year. It is the single most prevalent symptom on presentation to a physician's office. Up to 40% of these complaints result in a referral to a pulmonologist. Although, the cough is an essential defense mechanism, still, chronic cough may cause significant morbidity and substantially affect the quality of life and psychosocial wellbeing.

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Key information

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Searle Company Limited

Karachi, Sindh, 72500, Pakistan

About this study

Globally, the prevalence of acute cough is 9 to 64%, whereas chronic cough is >10% in most countries or regions, ranging from 7.2%-33%. In Pakistan, a few studies have examined chronic cough resulting from specific occupations, such as those involving brick kilns, textile work, or gem cutting. Additionally, 15.8% of subjects in a periurban area of Karachi City, Pakistan with cough lasting ≥ 2 weeks were found to have pulmonary TB. Overall, to estimate the prevalence and incidence of different coughs, there is no data available based on the local population, and the data assessing the quality of life of patients with different coughs is not available. Locally, few studies were conducted on cough syrups with a small sample size. However, no real data is available for the symptomatic management of cough about the patient's quality of life related to different coughs. The current study is designed to assess the response of different strengths of Syrup Hydryllin ( Syrup Hydryllin & Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan & Diphenhydramine) in the symptomatic management of cough in routine practice by physicians. The study's main objective is to assess the quality of life of the subjects suffering from the different types of cough.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with a clinical history of cough.
  • Patients aged ≥12 and ≤70 years inclusive of either sex.
  • The patient will be screened for COVID-19
  • The patient will be prescribed the study drug following an approved package insert
  • Written informed consent before participation in study-specific procedures

Exclusion criteria

  • Known hypersensitivity to Hydryllin product, the metabolites, or formulation excipients.
  • Covid Patients with moderate and severe condition requires hospitalization or/and associated with the complications.
  • Patients who have a contra-indication (refer to the Syrup Hydryllin prescribing information).
  • Pregnant (assessed on LMP)
  • Breastfeeding women (assessed on interview).

Treatment and study plan

Syrup Hydryllin

Drug

( Syrup Hydryllin & Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan & Diphenhydramine)

Primary outcomes

  1. • To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks -

    Time frame: 4 Months

    The effectiveness assesses by Leicester Cough Questionnaire (QoL questionnaire), The LCQ scale from 1-7, 1 is all the time and 7 is none of the time. The total score is 19 whereas 8 for Physical, 7 for Psychological and 4 for Social.

Secondary outcomes

  1. • To assess the overall safety of different strengths of Syrup Hydryllin in the cases presenting with different types of cough.

    Time frame: 4 Months

    The safety will be monitored from the first dose of HYDRYLLIN. The participants with treatment-related adverse events will be reported on Searle AE designed form.

Sponsors and collaborators

Lead sponsor

The Searle Company Limited Pakistan

Industry

Registry information

Acronym: HYD-EFFECT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2021
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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