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

NCT05129761 | Completed

• 1 other identifier: TSCL_HYD-EFFECT-001
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

Cough management, Cough syrup, Quality of Life

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (1)

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

  4 Months

Study Arms (1)

• Patient with a clinical history of cough

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.

Drug: Syrup Hydryllin

Interventions

Syrup Hydryllin DRUG

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

• Patient with a clinical history of cough

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Searle Company Limited Pakistan: lead

Study Sites (1)

The Searle Company Limited

Karachi, Sindh, 72500, Pakistan

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Syed Sarwar

  The Searle Company Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 22, 2021
• Study Start: November 28, 2021
• Primary Completion: June 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)