Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice (HYD-EFFECT)

The Searle Company

Status: Completed

Conditions: Cough

Treatments: Drug: Syrup Hydryllin

Study type: Observational

Funder types: Industry

Identifiers

NCT05129761

TSCL_HYD-EFFECT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

320 participants in 1 patient group

• Patient with a clinical history of cough

Description:

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. Subjects will be observed for overall safety and effectiveness of study drug from visit 1 (baseline visit, screening, and start of treatment), to visit 2 (Week 1-2, end of treatment) in the routine practice.

Treatment:

Drug: Syrup Hydryllin