Study to assess the Safety and effect of Wikoryl DS oral suspension in children having common cold with fever

Phase 4

Not yet recruiting

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

• Registration Number: CTRI/2022/10/046178
• Lead Sponsor: Alembic Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age: 2-12 years of age. (12-40 Kg body weight)

2. Genders Eligible for Study: both Males and Females

3. Patients with clinical diagnosis of common cold associated with fever. These symptoms may include rhinorrhea, nasal congestion, sneezing etc.

4. Patients whose guardians can adhere to the protocol

Exclusion Criteria

1. Patients known to be hypersensitive to investigational product

2. Patients with severe hepatic or renal dysfunction

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of Wikoryl DS Oral SuspensionTimepoint: Day 6

Secondary Outcome Measures

Name	Time	Method
To Change in symptom scores for fever, rhinorrhea, <br/ ><br>nasal congestion and sneezingTimepoint: Day 6