A post-marketing study of the marketed product Maxtra® P Oral Drops 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 125 mg, Phenylephrine Hydrochloride 2.5 mg and Chlorpheniramine Maleate 1 mg oral drops in symptomatic treatment of common cold in children.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/02/031207

Enrollment

200

Registered

2021-02-11

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 Oral Drops [Fixed dose combination (FDC) of Paracetamol 125 mg, Phenylephrine Hydrochloride 2.5 mg and Chlorpheniramine Maleate 1 mg oral drops): 1 ml to be administered every

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 2 to 5 years. 2. Children with symptoms of common cold of recent onset (lasting for more than 6 hours and less than 72 hours). 3. Parents or Legally Acceptable Representative (LAR) of the children willing to give informed consent and willing to comply with the study protocol.

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 investigator and parents / LAR 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 remission.Timepoint: 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