Active post marketing surveillance (PMS) to evaluate the safety and efficacy of Sinarest Oral Drops in infants of common cold or allergic rhinitis.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/11/037913

Enrollment

240

Registered

2021-11-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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] Health Condition 2: J309- Allergic rhinitis, unspecified

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 o

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: up to 1 year (weight: 2.5-11.8 kg) 2. Genders Eligible for Study: both Males and Females 3. Patients with confirmed clinical diagnosis of common cold or allergic rhinitis 4. Patients whose guardians can adhere to the Protocol

Exclusion criteria

Exclusion criteria: 1.Patients known to be hypersensitive to investigational product 2. 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 ContactDr Mayuresh Kiran

Centaur Pharmaceuticals Pvt Ltd

pramita@centaurlab.com02267609341

Outcome results

None listed

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