Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold

Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02656914

Enrollment

Registered

2016-01-15

Start date

2019-06-30

Completion date

2020-09-30

Last updated

2019-10-16

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

Conditions

Common Cold

Brief summary

The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold

Detailed description

Double blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation

Interventions

DRUGIrlanda-2-Association

Take 10 mL every 12 hours (2x/day), oral route.

DRUGPlacebo

Take 10 mL every 12 hours (2x/day), oral route.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double blind study

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain; * Signed consent.

Exclusion criteria

* Patients with any clinically significant disease that, in the investigator opinion, can´t participate in the study; * Patients with any laboratory finding or image finding that, in the investigator opinion, can´t participate in the clinical trial; * Patients with history of hypersensitivity to any of the formula compounds; * Participation in clinical trial in the year prior to this study; * Patients with vaccine reaction; * Patients who have uncontrolled asthma. However, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma; * Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract; * Patients with diabetes mellitus type I and II; * Pregnancy or risk of pregnancy and lactating patients; * Patients in use of drugs that can interfere with flu symptoms evaluation.

Design outcomes

Primary

Measure	Time frame
Determine efficacy of Irlanda-2-Association in the treatment of common cold symptoms.	7 days

Secondary

Measure	Time frame
Safety will be evaluated by the adverse events occurrences	7 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026