A clinical study of Polyherbal Pediatric Oral Drops in Symptomatic Management of Common Cold & Cough in infants and childre

Phase 3

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

• Registration Number: CTRI/2020/04/024916
• Lead Sponsor: Vasu Research Centre A Division of Vasu Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

Willing to provide written informed consent for participation in the study and adhere to the protocol requirements by parent.

Children of either sex having age group 3 months - 6 years (both inclusive).

Children presenting with symptoms of acute common cold prevailing for less than 48 hours.

Parentâ??reported nasal congestion severity score equating to stuffy or very stuffy (score 3 or 4 on a 5â??point categorical scale 0 [not stuffy at all] 1 [a tiny bit stuffy] 2 [a little stuffy] 3 [stuffy] 4 [very stuffy])Parents reporting of children having at least 2 of the following cold symptoms running nose, sneezing, sore throat, headache, body ache, Pyrexia and/or cough

Exclusion Criteria

Hypersensitivity to any of the components of formulation or the

excipients of the formulation.

Signs or symptoms of a more treatable disease (e.g. asthma,

pneumonia, laryngotracheobronchitis, sinusitis, allergic rhinitis).

Children who have taken or should be taking or are taking antibiotics,

antivirals, steroids, nasal decongestants, antihistamines, or other

medications that are expected to alleviate cold symptoms, or those

who have taken food that is expected to relieve cold symptoms within

one week of the start of the study Children with other than acute

cough ( >2 weeks).

History of reactive airways disease, asthma, or chronic lung disease.

Any condition that in opinion of the Investigator, does not justify the

subjectsâ?? participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified