A clinical trial to assess the effectiveness of paracetamol Immediate Release tablets in patients with fever.

An open label, randomized, controlled multicentre study to assess the effectiveness and tolerability of Para IR (Panacea Biotec Ltd, India) in comparison to Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) in patients with Fever - Para IR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/03/001653

Enrollment

110

Registered

2011-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients having fever at least 38 degrees celsius or 100.4 degrees Fahrenheit

Interventions

Intervention1: Para IR tablets: Dose: 500 mg Route: Oral Duration: Single dose Control Intervention1: Calpol tablets: Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) Control Intervention2:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex, 18-65years 2. Patients having fever at least 380C or 100.40F 3. Patients willing to give informed consent 4. Patients able to take oral medications

Exclusion criteria

Exclusion criteria: 1. Subjects requiring hospitalization 2. Subjects with known or suspected hypersensitivity to paracetamol or any the constituents of the formulation. 3. Subjects who have received any other investigational drug within 1 month prior to screening or enrollment. 4. Subjects who have received Paracetamol or any NSAID within 6 hours prior to enrollment. 5. Subjects who are receiving other medications or who have disease conditions that could interfere with the evaluation of drug efficacy or drug safety.

Design outcomes

Primary

Measure	Time frame
To compare the effectiveness of Para IR (Panacea Biotec Ltd) with Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) for faster relief of FeverTimepoint: One and half Hour	—

Secondary

Measure	Time frame
To compare the tolerability of Para IR (Panacea Biotec Ltd) with Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) in patients with FeverTimepoint: One and half Hour	—

Countries

India

Contacts

Public ContactDr Arani Chatterjee

aranichatterjee@panaceabiotec.com011-41679000

Outcome results

None listed

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