CoughHYD-EFFECTNCT05129761
Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice
An observational study of Cough, run by The Searle Company Limited Pakistan at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Cough
- What is being tested?
- Syrup Hydryllin
- Type of treatment
- Pill or oral medicine
- How many people
- 320 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2021to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cough
- Being tested
- Syrup Hydryllin
- Keywords
- Cough management, Cough syrup, Quality of Life
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syrup HydryllinDrug
( Syrup Hydryllin \& Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan \& Diphenhydramine)
| Study group | Role | What they receive |
|---|---|---|
| • 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. Receives: Drug: Syrup Hydryllin |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 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.
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.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start28 Nov 2021
- Primary completion1 Jun 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Searle Company Limited Pakistan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Syed Sarwar, Study director, The Searle Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129761
- Sponsor's protocol ID
- TSCL_HYD-EFFECT-001
- Acronym
- HYD-EFFECT
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice
- ClinicalTrials.gov ID
- NCT05129761
- Acronym / sponsor ID
- HYD-EFFECT / TSCL_HYD-EFFECT-001
- Conditions
- Cough
- Keywords
- Cough management, Cough syrup, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- The Searle Company Limited PakistanIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| • Patient with a clinical history of cough | – | Drug: Syrup HydryllinSyrup 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. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syrup Hydryllin( Syrup Hydryllin \& Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan \& Diphenhydramine) | Drug | • Patient with a clinical history of cough |
Primary outcome
• To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks -
Time frame: 4 Months
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.
1 secondary outcome
• To assess the overall safety of different strengths of Syrup Hydryllin in the cases presenting with different types of cough.
Time frame: 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Sarwar study director
The Searle Company Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by The Searle Company Limited Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks - (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.