EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN DYSPEPPSIA

EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN PARTICIPANTS DIAGNOSED WITH FUNCTIONAL DYSPEPPSIA: A RANDOMIZED AND DOUBLE-BLIND STUDY

This is a prospective, randomized, double - blind study of 474 male and female volunteers with dyspeppsia diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from March 2025 to March 2027.

Hypothesis:

As a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolia Raddi) for the treatment of participants diagnosed with functional dyspepsia efficacy not inferior to therapy based on the use of omeprazole.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: Oral Aroeira; Drug: Omeprazole 20Mg Capsule

Detailed Description

This is a prospective, randomized, double - blind study of 474 male and female volunteers with dyspeppsia diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from March 2025 to March 2027.

Hypothesis:

As a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolia Raddi) for the treatment of participants diagnosed with functional dyspepsia efficacy not inferior to therapy based on the use of omeprazole.

The initial proposal of the project was a prospective, comparative and double blind study between aroeira and omeprazole together with antibiotic treatment for patients diagnosed with gastritis caused by Helicobacter pylori, whose dosage of aroeira (Schinus terebinthifolia Raddi) was 1 tablet of 640 mg, every 12 hours for 4 weeks and omeprazole was 1 capsule of 20 mg, 12/12h, for 4 weeks.

Due to Anvisa requirements, and taking into account the current rationale for gastritis related to this infection, we analyzed that a project with gastritis without the association with H. pylori would not be ideal. So, we are proposing a comparative study with the same drugs (aroeira versus omeprazole) in evaluating the complete relief of dyspeptic symptoms in Dyspepsia Functional. In this new proposal, the N will be 474 participants, maintaining a 1:1 ratio. Research participants will be those who report at least 1 of the 5 dyspeptic symptoms (nausea, heartburn, pain epigastric pain, abdominal discomfort aggravated/relieved by meals and feeling of early satiety) with onset more than 6 months, lasting at least 3 months and excluding other diagnoses by upper digestive endoscopy (EDA).

Our primary objective will be "Compare the effectiveness of oral mastic (Schinus terebinthifolia Raddi) versus omeprazole in relieving complete description of the symptoms of functional dyspepsia. The secondary objectives will be:

1. Evaluate the improvement in the quality of life of participants with dyspeptic symptoms within each treatment (before and afterwards) and between aroeira versus omeprazole at the end of treatment;
2. Evaluate complaints within each treatment (before and after) and between oral mastic versus omeprazole at the end of the treatment treatment;
3. Evaluate possible adverse events to treatment with oral mastic versus omeprazole therapy reported by the participant.

Clinical Trial Protocol Oral Aroeira medicine (Schinus terebinthifolia Raddi) Version 03 of 14-June-2023 HB-F3-01/2019 Sponsor: INFAN - Indústria Química Farmacêutica Nacional S/A

The dosage of this study will be: 1 tablet of oral Aroeira (Schinus terebinthifolia Raddi) of 640mg, once a day, at least period of 4 weeks, and omeprazole, 1 capsule of 20mg, once a day, for a period of 4 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 474
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: JAN CARLO MORAIS OLIVEIRA B DELORENZ, PhD; Phone Number: 11989780869; Email: jancarlo@hebron.com.br
• Study Contact Backup: Name: Haliny Magalhães, Pharm. B.; Email: haliny@hebron.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

To be eligible to participate in this study, an individual must meet all of the following criteria:

Report of at least 1 of the 5 dyspeptic symptoms, with onset more than 6 months ago, with at least least 3 months in duration, according to the ROME IV Classification criteria:

• Nausea;
• Heartburn;
• Epigastric pain;
• Abdominal discomfort aggravated/relieved by meals;
• Feeling of early satiety.

Manifestation of the desire to participate in the study in a free and informed manner.

Age range between 18 and 80 years old;

Ability and desire to use an acceptable method of contraception listed below during the study and until the last follow-up visit:

• Women - condoms, oral, topical, injectable or implantable contraceptive medications, Intrauterine Devices (IUDs) with or without hormones and true abstinence that is aligned with the participant's preferred and usual lifestyle (periodic abstinence [e.g., methods of table, ovulation, symptothermic, post-ovulation], declaration of abstinence during the period of study or coitus interruptus are not acceptable methods of true abstinence).
• Women - will be referred to a gynecologist for screening and better definition of the method;
• Men - guidance on condom use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated Group; Active Group with 237 participants undergoing treatment with oral mastic (Schinus terebinthifolia Raddi), 1 tablet of 640 mg + 1 placebo capsule, once a day, for a period of 4 weeks	Drug: Oral Aroeira; Active Group oral Aroeira (Schinus terebinthifolia Raddi), 1 tablet of 640 mg + 1 placebo capsule, once a day, for a period of 4 weeks.
Active Comparator: Control Group; Comparator Group with 237 participants undergoing treatment with omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.	Drug: Omeprazole 20Mg Capsule; Comparator Group omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete relief dyspeppsia symptom	Assessment of the proportion of participants with complete relief of dyspeptic symptoms. Complete relief of symptoms will be considered if the scores obtained in items #3, #5 and #7 of the ROME III questionnaire are lower than or equal to their respective reference values for the diagnosis of each symptom of functional dyspepsia.	30 days after the first day treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life quality Improvement	Assessment of the proportion of improvement in quality of life using the SF-36 quality of life questionnaire, taking into account the domains "Functional capacity", "Limitation due to physical aspects", "Pain", "General health status", "Vitality ", "Social aspects", "Emotional aspects" and "Mental health" generating a continuous numerical variable (between 0 and 100, where 0 is bad and 100 is good) corresponding to each domain.	60 days after the first day treatment

Collaborators and Investigators

• Sponsor: Infan Industria Quimica Farmaceutica Nacional
• Collaborators: Hospital Universitário Oswaldo Cruz
• Investigators: Principal Investigator: Severino B Santos, PhD, Hospital Univeristário Oswaldo Cruz

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: HB/F3-001/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No