Evaluation of the Use of Guaco Syrup for Dilation and Reduction of Inflammation in the Respiratory Tract Through Pulmonary Function Tests in Asthmatic Volunteers

Evaluation of bronchodilator and anti-inflammatory activity of guaco syrup in humans by pulmonary function tests in asthmatics volunteers

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-4n26tf

Enrollment

Unknown

Registered

2016-12-20

Start date

2016-07-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Asthma

Interventions

EVALUATION OF BRONCHODILATOR ACTIVITY 40 volunteers will be randomly divided into three groups with the same number of participants. The first group will receive 15 ml of guaco syrup followed by sal

Drug

B01.650.940.800.575.100.100.512

D02.033.100.291.057

D26.660

Eligibility

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Moderate persistent asthm (according to the classification criteria included in the IV Brazilian Guidelines for Asthma Management); aged between 18 and 60 years; diagnosis of asthma performed by spirometry (FEV1 / FVC <90%, with FEV1 being forced expiratory volume in 1 second and FVC functional vital capacity).

Exclusion criteria

Exclusion criteria: Volunteers who had a stroke or acute myocardial infarction in the last three months; aortic aneurysm; systolic blood pressure higher than 200 mmHg or diastolic blood pressure higher than 90 mmHg; epileptics; unable to understand the procedure and implications of the study; with induced bronchoconstriction by recent spirometry; recent airway infection (during the last six weeks); during or near an asthma exacerbation; pregnant or breastfeeding women; in use of cholinesterase inhibitors; and smokers.

Design outcomes

Primary

Measure	Time frame
Bronchodilator Activity Positive bronchodilator response verified by spirometry test. Elevation of FEV1 in 200 ml or more and, in parallel, increase in FEV1 by 12% when compared to baseline or 7% when compared to the value predicted for the volunteer. Anti-inflammatory activity Positive anti-inflammatory response evaluated by spirometry test. After the intervention, the increase in methacholine dose required to cause a 20% decrease in FEV 1 values characterizes the anti-inflammatory effect.	—

Measure

Time frame

Bronchodilator Activity Positive bronchodilator response verified by spirometry test. Elevation of FEV1 in 200 ml or more and, in parallel, increase in FEV1 by 12% when compared to baseline or 7% when compared to the value predicted for the volunteer. Anti-inflammatory activity Positive anti-inflammatory response evaluated by spirometry test. After the intervention, the increase in methacholine dose required to cause a 20% decrease in FEV 1 values characterizes the anti-inflammatory effect.

—

Secondary

Measure	Time frame
We don't expect secondary outcomes.	—

Countries

Brazil

Contacts

Public ContactCarolina ;Roberto Garcia;Pontarolo

Universidade Federal do Paraná;Universidade Federal do Paraná

carolinagieselgarcia@gmail.com;pontarolo@ufpr.br+55(41)33604095;+55 (41) 3360 4094

Outcome results

None listed

Source: REBEC (via WHO ICTRP)