Clinical trial NCT05129761: Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice
Official title: Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cough
Keywords: Cough management, Cough syrup, Quality of Life
Lead sponsor: The Searle Company Limited Pakistan
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 320
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population including patients of either sex between ≥12 and ≤70 years, suffering from cough (acute, subacute, and chronic), will be enrolled in the study in the random order. The random number will be marked using a random number table.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: • To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks -
timeFrame: 4 Months
Secondary outcomes:
measure: • To assess the overall safety of different strengths of Syrup Hydryllin in the cases presenting with different types of cough.
timeFrame: 4 Months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Searle Company Limited
state: Sindh
Study officials:
affiliation: The Searle Company Limited
name: Syed Sarwar
role: STUDY_DIRECTOR
References: