A post-marketing study of the marketed product Maxtra® PDS syrup for the evaluation of safety and effects in children having common cold.

An active post marketing surveillance study to evaluate the safety and efficacy of a fixed dose combination of Paracetamol 250 mg, Phenylephrine Hydrochloride 5mg and Chlorpheniramine Maleate 2 mg per 5ml syrup in symptomatic treatment of common cold in children.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/02/031188

Enrollment

200

Registered

2021-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: J00- Acute nasopharyngitis [common cold]

Interventions

Intervention1: Maxtra P DS Syrup [Fixed dose combination (FDC) of Paracetamol 250 mg, Phenylephrine Hydrochloride 5mg and Chlorpheniramine Maleate 2 mg per 5ml syrup): For patients in 6 to 11 years of

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients =6 years to 2. Patients with symptoms of common cold of recent onset, for more than 6 hours and less than 72 hours. 3. Children who give assent to participate in the study (For participants between 6 & 12 years, verbal assent is admissible in presence of their parents / Legally Acceptable Representative (LAR). Participants aged between 12 & 18 years should personally sign and date a separately designed, written assent form.)

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to any of the ingredients of the formulation. 2. Patients with hepatocellular insufficiency and in patients with hepatic failure or active liver disease. 3. Patients who took an antihistamine, analgesic or decongestant 1 day prior to study enrollment. 4. Patients otherwise judged to be inappropriate for inclusion in the study by the investigator

Design outcomes

Primary

Measure	Time frame
1.Proportion of patients reporting adverse events during the study period. 2.Assessment of therapy by investigators and patients at the end of the study period.Timepoint: Day 0 and Day 5	—

Secondary

Measure	Time frame
1. Proportion of patients experiencing reduction in severity of symptoms. 2. Proportion of patients with complete remissionTimepoint: Day 0 and Day 5	—

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Limited

Bhupesh.Dewan@zuventus.com022-30610000

Outcome results

None listed

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