Assessment of safety of Grilinctus Paediatric Syrup in management of common cold.

Phase 4

Completed

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

• Registration Number: CTRI/2017/07/009177
• Lead Sponsor: Franco Indian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-02
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

1. Childrenâ??s of either sex having age group 4-10 years (both inclusive).

2. Childrenâ??s presenting with symptoms of acute common cold prevailing for less than 48 hours

3. Childrenâ??s that are having the four symptoms of Common cold.

Sneezing, Nasal obstruction, Nasal discharge, Sore throat, Chilliness, Headache, fever and Cough.

4. Childrenâ??s having systemic symptom score <= 12.

5. Patient able to understand and follow study procedures agrees to participate in the study by giving his/her written informed consent.

Exclusion Criteria

1. Children with asthma requiring treatment or had required emergency treatment within 1 month.

2. Hospitalization 3 months prior to the trial.

3. Suspected bacterial infections, recent use of antimicrobial drugs, and intranasal treatment at first presentation.

4. Patient requiring, corticosteroids, cromolyn sodium, nedocromil and inhaled cholinergics, oral or long acting beta-agonist, theophylline and other leukotriene modifiers.

5. History of hypersensitivity to any ingredient of the investigational product.

6. If has any form of Psychiatric Illness and undergoing treatment for the same.

7. If has taken immunosuppressive therapy or steroids as treatment in the last 3 months.

Study & Design

• Study Type: PMS
• Study Design: Not specified