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

NCT04069286 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HB/F3-001/2019
• Study Type: interventional
• Target: 474
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Life quality Improvement

  60 days after the first day treatment

Study Arms (2)

Treated Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Oral Aroeira 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.

Treated Group

Omeprazole 20Mg Capsule DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Infan Industria Quimica Farmaceutica Nacional: lead
• Hospital Universitário Oswaldo Cruz: collaborator

MeSH Terms

Conditions

Dyspepsia

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Severino B Santos, PhD

  Hospital Univeristário Oswaldo Cruz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JAN CARLO MORAIS OLIVEIRA B DELORENZ, PhD

CONTACT

11989780869; jancarlo@hebron.com.br

Haliny Magalhães, Pharm. B.

CONTACT

haliny@hebron.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: March 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share