Active post marketing surveillance study to evaluate the safety and efficacy of Sinarest Syrup in children with common cold

A multicentric, non-randomized, open label, non-comparative, active post marketing surveillance study to evaluate the safety and efficacy of Sinarest Syrup in children with common cold - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/11/077305

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 syrup: Sinarest syrup is a FDC of Paracetamol 125 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 1 mg, Sodium citrate 60 mg and mentholated flavoured syrupy bas

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 2 to 12 years having body weight 6 to 40 kg Patients of either sex (male or female) Patients with a confirmed diagnosis of common cold Patients and guardians who are ready to adhere to the protocol

Exclusion criteria

Exclusion criteria: Patients who are known to be hypersensitive to the investigational product Patients with severe hepatic or renal dysfunction

Design outcomes

Primary

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

Secondary

Measure	Time frame
NILTimepoint: NIL	—

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