Evaluating Sinarest New Tablet for Adult with Common Cold: Safety and Efficacy Study

A Multicentric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance study to evaluate the Safety and Efficacy of Sinarest New Tablet in adults with common cold. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/11/077243

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 New Tablet- FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet: Sinarest New Tablet: 1 tablet thrice a day for the active

Eligibility

Inclusion criteria

Inclusion criteria: Patients between the ages of 18 to 65 years. Patients of either sex including male or female. Patients with a confirmed diagnosis of common cold. Patients who can adhere to the protocol and are ready to sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients hypersensitive to the investigational product Patients with severe hepatic or renal dysfunction Pregnant or lactating Women Patients who cannot adhere to the Protocol (mentally ill or patients with psychological problems)

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
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