Evaluating Sinarest Oral Drops for Infants with Common Cold: Safety and Efficacy Study

A multicentric, non-randomized, open label, non-comparative, active post marketing surveillance (PMS) study to evaluate the safety and efficacy of Sinarest Oral Drops in infants of common cold. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/11/077332

Enrollment

280

Registered

2024-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Sinarest Oral Drops: Sinarest Oral Drops is a FDC of Chlorpheniramine maleate 1 mg, Phenylephrine Hydrochloride 2.5 mg and Paracetamol 125 mg per ml which is indicated for common cold i

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age up to 1 year having body weight of up to 11.8 kg Patients of both genders including male and female. Patients with a confirmed diagnosis of common cold Patients whose guardians are ready to sign the informed consent form and can adhere to the protocol.

Exclusion criteria

Exclusion criteria: Patients hypersensitive to the investigational product Patients with severe Hepatic or Renal dysfunction

Design outcomes

Primary

Measure	Time frame
1.Reduction in mean total symptom score 2.Percentage Reduction in mean total symptom scoreTimepoint: Day 1, day 3 and day 5	—

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactMs Aakansha Singh

Centaur Pharmaceuticals Pvt Ltd

pramita@centaurlab.com02267609341

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026