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

Launched by INFAN INDUSTRIA QUIMICA FARMACEUTICA NACIONAL · Aug 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a natural treatment called Aroeira (from the plant Schinus terebinthifolia) compared to a common medication called omeprazole for people with dyspepsia, which is a term used for symptoms like nausea, heartburn, and stomach discomfort. The trial will involve 474 volunteers of different ages, both men and women, who have been experiencing these symptoms for at least six months. Researchers want to find out if Aroeira works just as well as omeprazole in alleviating these symptoms.

To be eligible for the study, participants need to be between 18 and 80 years old and report at least one of the five specific dyspeptic symptoms for a certain period. They also need to be willing to use a reliable method of birth control during the study. If individuals decide to participate, they can expect to receive either Aroeira or omeprazole in a way that ensures neither they nor the researchers know which treatment they are getting, which helps ensure fair results. It's important for potential participants to understand that this study is still in the planning stages and is not yet recruiting volunteers.

Gender

ALL

Eligibility criteria

• 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.