Active post marketing surveillance to evaluate the Safety and Efficacy of Sinarest New Tablet in adults of common cold or allergic rhinitis.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/11/037857

Enrollment

240

Registered

2021-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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 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: 1. Patients of age > 18 years and 2. Patients of either sex including male or female. 3. Patients with confirmed clinical diagnosis of common cold or allergic rhinitis 4. Patients who can strictly adhere to the protocol and ready to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients known or thought to be hypersensitive to the investigational product. 2. Patients with severe hepatic or renal dysfunction. 3. Pregnant or lactating women. 4. Patients who cannot adhere to the protocol (Mentally ill or patients with the 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
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