Evaluation of Green Propolis as a oral Anti-inflammatory Drug

Evaluation of Clinical Safety and Efficacy of an Anti-inflammatory Abtained from Active Ingredient of the Brazilian Biodiversity - : evaluation of clinical safety and efficacy of an anti-INflammatory obtained from active ingredient of the BRAazilian biodiversity.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-9zmfs9

Enrollment

Unknown

Registered

2013-08-21

Start date

2013-01-01

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

Healthy volunteers

Interventions

Safety and efficacy protocol, non-randomized and without placebo usage. Safety 1: Two phases protocol with 16 healthy volunteers. 16 healthy volunteers are administered a drug cocktail containing: M

Drug

C25.723.276

SP5.001.047.153

Eligibility

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers of both genders, non-smokers, aged 18 to 60 years and weighing within 15% of the normal weight for men and women taking into account their height and physical structure will be included. Participation of female volunteers is conditioned to not be pregnant or breastfeeding.

Exclusion criteria

Exclusion criteria: Volunteers with a history of smoking, alcoholism or drugs abuse, diagnosed as having any cardiac, renal, gastrointestinal, hepatic and pulmonary disease, neurological, psychiatric, hematological or metabolic disorders will be excluded. Also individuals with any known hypersensitivity to drugs who are receiving medications one week before the study or during its implementation and not willing to participate in all stages of this study will not be accept.

Design outcomes

Primary

Measure	Time frame
The endpoint expected on safety protocols is a non-significant change on activity of citochrome P450 enzymes or P-glycoprotein. The statistical approach for the analysis of potential interaction between propolis extract-fexofenadine will be based on geometrical mean ratio of the observed pharmacokinetic measures for fexofenadine with and without the propolis extract (EPP-AF). The conclusion of non-interaction will be done if the CI90% for log AUC ratio or log Cmax ratio of fexofenadine obtained with or without EPP-AF lies on 0.80 to 1.25 interval to AUC and 0.70 to 1.43 to Cmax. For citochrome P450 interaction the same strategy will be done, using CI90% for AUC, metabolic ratio or clearance according the probe (drug) used. For efficacy protocol the endpoint is set as a reduction of at least 50% from baseline urinary Prostaglandin E2 excretion with the use of higher doses of propolis extract (EPP-AF)	—

Measure

Time frame

The endpoint expected on safety protocols is a non-significant change on activity of citochrome P450 enzymes or P-glycoprotein. The statistical approach for the analysis of potential interaction between propolis extract-fexofenadine will be based on geometrical mean ratio of the observed pharmacokinetic measures for fexofenadine with and without the propolis extract (EPP-AF). The conclusion of non-interaction will be done if the CI90% for log AUC ratio or log Cmax ratio of fexofenadine obtained with or without EPP-AF lies on 0.80 to 1.25 interval to AUC and 0.70 to 1.43 to Cmax. For citochrome P450 interaction the same strategy will be done, using CI90% for AUC, metabolic ratio or clearance according the probe (drug) used. For efficacy protocol the endpoint is set as a reduction of at least 50% from baseline urinary Prostaglandin E2 excretion with the use of higher doses of propolis extract (EPP-AF)

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Brazil

Contacts

Public ContactEduardo Coelho

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

ebcoelho@fmrp.usp.br+55(16)3602-2543

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 25, 2026