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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-28

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Cough Study In Children

NCT01257542

Common Cold Infections, Upper Respiratory Tract

TERMINATED PHASE4

Cough Desensitization Therapy for Cough Hypersensitivity Syndrome

NCT04256733

Cough

COMPLETED EARLY_PHASE1

Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo

NCT02062710

Cough Reflex Sensitivity

COMPLETED PHASE4

PMCF Study to Evaluate Performance and Safety of "NASAL SPRAYS " Used to Relieve Nasal Congestion and Dryness

NCT05843071

Nasal Congestion Nasal Dryness

COMPLETED NA

Otrivine: Quality of Life (QoL) Impact in a Real-World Setting

NCT05556148

Common Cold

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cough

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

• 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.

Syrup Hydryllin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Syrup Hydryllin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No