Assessment of Clinico-Epidemiological Profile and Effectiveness Of Codeine Phosphate 10 Mg + Triprolidine Hcl 1.25 Mg, Syrup In Patients With Dry Cough

A Prospective, Single-Arm, Multi-Centric, Open-Label, Post-Market Observational Surveillance (PMOS) Study To Evaluate The Clinico-Epidemiological Profile And Effectiveness Of A Fixed-Dose Combination (FDC) Of Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, Per 5 Ml, Oral Syrup For The Symptomatic Management Of Dry Cough In Patients Not Responding To Non-Opioid Based Antitussives - NA

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/12/078427

Enrollment

250

Registered

2024-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: R05- Cough

Interventions

Intervention1: FDC Of Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, Per 5 Ml, Oral Syrup: In this study patients will be prescribed 10ml Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, P

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of both sexes greater than18 years of age. 2. Patients diagnosed with dry cough for at least 1 week and not responding to non-opioid-based antitussives. 3. Patients prescribed codeine phosphate and triprolidine combination for symptomatic relief of dry cough. 4. Dry cough associated with any etiology, as per the discretion of the treating physician and in accordance with the prescribing information. 5. Patients willing and able to comply with the study procedures and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients in whom Codeine phosphate and Triprolidine HCL are contraindicated. 2. Patients with a known history of hypersensitivity or idiosyncratic reaction to any ingredients of the product. 3. Patients having respiratory depression, COPD, Asthma attack. 4. Patients having alcohol intoxication, Narrow-angle glaucoma, Urinary retention, raised intracranial tension, Head injury. 5. Patients having peptic ulcer, Paralytic ileus, Intestinal Obstruction, Biliary or gall bladder problem. 6. Patients having severe hypertension, severe coronary artery disease. 7. Patients having severe hepatic or renal diseases, Mono Aminase Oxidase Inhibitor (MAOI) therapy or for 2 weeks after stopping MAOI therapy, known CYP2D6 ultra-rapid metabolizers Pregnant or breast-feeding women, Newborn or premature infants.

Design outcomes

Primary

Measure	Time frame
To evaluate the clinico-epidemiological profile of patients presenting with dry cough.Timepoint: Day 1 and 7	—

Secondary

Measure	Time frame
Effectiveness 1. To evaluate the effectiveness of codeine 2. To evaluate the quality of life (QoL) of patients Safety 1. To evaluate the safety and tolerability of treatmentTimepoint: Day 1 and 7	—

Countries

India

Contacts

Public ContactDr Shivani Acharya

Abbott Healthcare Private Limited

kartik.peethambaran@abbott.com912250462305

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026