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

Phase 4

Completed

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

• Registration Number: CTRI/2021/02/031390
• Lead Sponsor: Zuventus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-20
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Patients of either gender of age between >=18 years to 60 years.

2.Patients with symptoms of common cold of recent onset, for more than 6 hours and less than 72 hours.

3.Patients willing to give written informed consent.

Exclusion Criteria

1.Hypersensitivity to any of the ingredients of the formulation.

2.Patients taking a monoamine oxidase inhibitor (MAOI), or barbiturates

3.Pregnancy or breastfeeding women.

4.Patients with hepatocellular insufficiency and in patients with hepatic failure or active liver disease.

5.Patients who took an Antihistamine, Analgesic or Decongestant 1 day prior to study enrollment.

6.Patients otherwise judged to be inappropriate for inclusion in the study by the investigator

Study & Design

• Study Type: PMS
• Study Design: Not specified