Status:
NOT_YET_RECRUITING
EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN DYSPEPPSIA
Lead Sponsor:
Infan Industria Quimica Farmaceutica Nacional
Collaborating Sponsors:
Hospital Universitário Oswaldo Cruz
Conditions:
Dyspepsia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 Marc...
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 Marc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT04069286
Start Date
March 1 2025
End Date
March 1 2027
Last Update
April 29 2024
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