A Phase III Randomized Controlled Study Of Efficacy & Tolerability Of Fixed Dose Combination Of Paracetamol 500 Mg + Phenylephrine Hydrochloride 5mg + Diphenhydramine 25 Mg + Caffeine 30 Mg (Nasivion Tablets) Versus Paracetamol 500 Mg And A Fixed Dose Combination Containing Paracetamol 500 Mg + Chloropheneraminemaleate 2 Mg + Phenylephrine 10 Mg (Control) In Patients With Common Cold (Coryza)

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000879

Enrollment

200

Registered

2010-01-05

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- Common Cold (Coryza)

Interventions

Intervention1: Nasivion Tablet: Combination of paracetamol 500 mg + phenylephrine hydrochloride 5mg + diphenhydramine 25 mg + caffeine 30 mg. one tablet three times a day. Control Intervention1: Contr

Eligibility

Inclusion criteria

Inclusion criteria: 1.All subjects selected for this study will be within the age group of 18 to 60 years. 2.Patients suffering from common cold (coryza) associated with symptoms of rhinorrhoea, nasal congestion and fever. 3.Patients who have provided with their informed consent. 4.Patients who can come for follow-up as per the study schedule

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to ingredients of study/active comparators. 2. Patients with productive cough. 3. Patients with clinical suspicion of any local (nasal) or systemic bacterial infection. 4. Patients having hypertension (defined as sitting blood pressure of >140 mm systolic and/or 90 mm diastolic) 5. Patients with any previous H/O or current episode of cardio-vascular disorders. 6. Known renal or hepatic illness. 7. Pediatric and Pregnant patients. 8. Patients with H/O drug/alcoholic/substance abuse. 9. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study

Design outcomes

Primary

Measure	Time frame
Clinical response is defined as complete resolution of the symptoms of coryza (sneezing, nasal blockade, rhinorrhoea & loss of smell).Timepoint: Post 5 day treatment period	—

Secondary

Measure	Time frame
-Fever evaluated by measuring the body surface temperature from auxillary pit -Dry cough evaluated on 4 point scale. Body ache evaluated on 0-10 Visual Analogue Scale (VAS) by clinical Investigator. -Change in the symptom scores -Physicians Global Assessment of Response to Therapy (PGART) on a 4-point scale. -Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale. Timepoint: -at baseline, day 3 & day 5.	—

Measure

Time frame

-Fever evaluated by measuring the body surface temperature from auxillary pit -Dry cough evaluated on 4 point scale. Body ache evaluated on 0-10 Visual Analogue Scale (VAS) by clinical Investigator. -Change in the symptom scores -Physicians Global Assessment of Response to Therapy (PGART) on a 4-point scale. -Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale. Timepoint: -at baseline, day 3 & day 5.

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Countries

India

Contacts

Public ContactDr Khokan Debnath

Merck Limited

amarinder.singh@merck.co.in91-22-66609070

Outcome results

None listed

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