Safety and Efficacy study of Nasal Spray on Children and Adolescents with common cold

Completed

• Conditions: Acute nasopharyngitis [common cold]. Ayurveda Condition: pratysyaya,

• Registration Number: CTRI/2022/12/048270
• Lead Sponsor: ITC Life Sciences and Technology Centre

Brief Summary

This is a double blind, randomized (1:1), comparatorcontrolled, parallel-group, multi-centre study to test the product safety andefficacy in relieving cold symptoms in Paediatric and Adolescent subjects withearly symptoms of common cold and meeting all inclusion and no exclusioncriteria. Study duration is for 21 days with intervention period of 14 days.After passing the eligibility criteria, written Informedconsents and Assents will be obtained and the subjects will be randomized intoone of the 2 treatment groups as per randomization schema. Homogenous andUniform distribution of subjects in both groups basis symptom severity(Mild andModerate), gender, mean age yrs will be attempted. Cold severity as per specific measures, Local irritation willbe assessed by Investigator and Subjects / parents/ Guardians under supervisionof study Investigator / personnel at specified frequency.Viral load assessmentthrough nasal swabs will be performed on Day 1 and Day 4. Subjects will begiven a detailed instruction on product use and recording in the subject dairy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Last Update Posted: 2023-05-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1.Subjects with common cold symptoms.
• 2.Subjects with cold symptom severity within the specified score range.
• 3.Subject who agrees to give informed consent / assents and comply with the study procedures.

Exclusion Criteria

• Subjects with history/presence of clinically significant condition/disorder/allergy to herbal products (self-reported), or regularly consuming certain products as per invetigator judgement could interfere with the results of the study or the safety of the subject.
• Subjects tested positive for SARS-CoV-2 by Rapid Antigen Test.
• Subjects who test negative for viral load at baseline.
• Subjects with co-existing bacterial/secondary infections.
• Subjects having taken influenza vaccination within the last 3 months prior to screening visit.
• 6.Subjects having common cold or flu like symptoms for > 48 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in Total Symptom Score (TSS) and Viral Load at different time points in treatment arm in comparison with Baseline and comparator	Day 2/ 3/ 4/ 5/ 7

Secondary Outcome Measures

Name	Time	Method
Mean change in efficacy parameters including Questionnaire based assessments at different time points up to 21 days	Upto Day 21
Percent of individuals with relapse post intervention	Upto Day 21
Overall product safety	Upto Day 21

Trial Locations

Locations (2)

BGS Global Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

Radhakrishna Multispeciality Hospital & IVF Center; 🇮🇳 Bangalore, KARNATAKA, India

BGS Global Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr Ramesh M

Principal investigator

9877980038

drrameshm.research@gmail.com