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

NCT ID: NCT04069286

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-03-31

Brief Summary

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.

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.

Conditions

Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Oral Aroeira

Intervention Type: DRUG

Active Group oral Aroeira (Schinus terebinthifolia Raddi), 1 tablet of 640 mg + 1 placebo capsule, once a day, for a period of 4 weeks.

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.

Group Type: ACTIVE_COMPARATOR

Omeprazole 20Mg Capsule

Intervention Type: DRUG

Comparator Group omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.

Interventions

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.

Intervention Type: DRUG

Omeprazole 20Mg Capsule

Comparator Group omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitário Oswaldo Cruz

UNKNOWN

Sponsor Role: collaborator

Infan Industria Quimica Farmaceutica Nacional

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Severino B Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Univeristário Oswaldo Cruz

Central Contacts

JAN CARLO MORAIS OLIVEIRA B DELORENZ, PhD

Role: CONTACT

jancarlo@hebron.com.br

11989780869

Haliny Magalhães, Pharm. B.

Role: CONTACT

haliny@hebron.com.br

Other Identifiers

HB/F3-001/2019

Identifier Type: -

Identifier Source: org_study_id