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

Cough Clinical Trial

— HYD-EFFECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129761
• Other study ID #: TSCL_HYD-EFFECT-001
• Status: Completed
• Start date: November 28, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2024
• Source: The Searle Company Limited Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cough

Intervention

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

Locations

Country	Name	City	State
Pakistan	The Searle Company Limited	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
The Searle Company Limited Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks -	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.	4 Months
Secondary	• To assess the overall safety of different strengths of Syrup Hydryllin in the cases presenting with different types of cough.	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.	4 Months