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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05129761
Acronym
HYD-EFFECT
Enrollment
320
Registered
2021-11-22
Start date
2021-11-28
Completion date
2023-11-01
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Keywords

Cough management, Cough syrup, Quality of Life

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.

Interventions

DRUGSyrup Hydryllin

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

Sponsors

The Searle Company Limited Pakistan
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
• To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks -4 MonthsThe 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

MeasureTime frameDescription
• To assess the overall safety of different strengths of Syrup Hydryllin in the cases presenting with different types of cough.4 MonthsThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026