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Clinical Trials/CTRI/2020/05/025373
CTRI/2020/05/025373CompletedPhase 3

A Prospective, Interventional, Randomized, Double blind, placebo Controlled, three-arm, Clinical Study to Evaluate the Efficacy and Safety of GRIPOUT (Paracetamol 500 mg + Phenylephrine HCL 5 mg + Chlorpheniramine maleate 2 mg + Caffeine anhydrous15 mg) tablet in the Treatment of common cold and flu syndrome - ICBIO/CR/ELPL/0125/106

EURO LIFE CARE PVT LTD0 sites90 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
90
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •Subjects who meet the following criteria will be considered eligible to participate in the study
  • •1.Male or Female having the age of 18 to 55 years
  • •2.Presented symptoms of recent onset, for more than 6 hours and less than 72 hours characterizing one of the following conditions
  • •The common cold, which consists of at least 2
  • •symptoms among the 10 following: sneezing,
  • •rhinorrhea, nasal congestion, headache, muscle
  • •pain, discomfort in the throat, sore throat,
  • •dysphonia, cough, fever, the latter being of
  • •moderate to severe intensity through a symptom
  • •severity scale of 4 points
  • •The flu syndrome, which consists of fever of at least 100.58°F and headache of moderate or severe intensity or myalgia or arthralgia moderate or severe using a scale of severity of symptoms of 4 points
  • •3.Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.

Exclusion Criteria

  • •1.Patients who are not willing to give written informed consent.
  • •2.Any known hypersensitivity to the study products.
  • •3.Pregnant and lactating women.
  • •4.Any history of seasonal or perennial allergic rhinitis.
  • •5.Patients who have taken treatment for the presenting symptom within 7 days of screening.
  • •6.Use of monoamine oxidase inhibitors or barbiturates
  • •7.Patients who received influenza vaccine within 7 days of screening.
  • •8.Patients who in the opinion of attending physician may require antibiotic treatment.
  • •9.Any lab findings or clinical findings that in the opinion of treating physician may appear as risk to the patient.
  • •10.Participation in any clinical trials prior to 30days.

Investigators

Sponsor
EURO LIFE CARE PVT LTD

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