Evaluating a new digestive aid for chronic dyspepsia
Evaluating the Efficacy of "Digestive Aid" in Functional Dyspepsia: A Randomized Double Blind Control Trial
NA · Tehran University of Medical Sciences · NCT06958952
This study is testing a new digestive aid to see if it can help people with chronic stomach discomfort feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tehran University of Medical Sciences (other) |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06958952 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of a new product called 'Digestive Aid' in patients suffering from functional dyspepsia, a common gastrointestinal disorder characterized by symptoms such as epigastric pain and early satiation. The study is designed as a double-blind, placebo-controlled trial, where participants will be randomly assigned to receive either the Digestive Aid or a placebo for two months. The diagnosis of functional dyspepsia will be made based on the Rome 4 criteria, and the severity of symptoms will be assessed using the Leeds dyspepsia questionnaire. The trial aims to provide insights into the potential benefits of this new treatment approach for dyspeptic patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with new onset functional dyspepsia.
Not a fit: Patients with known gastrointestinal diseases or those currently taking medications that affect gastrointestinal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms of functional dyspepsia for many patients.
How similar studies have performed: While there have been studies on various treatments for dyspepsia, the specific approach of using this 'Digestive Aid' is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The new onset dyspeptic patients Exclusion Criteria: * Participants with co-morbidities (known GI diseases) * Taking medications, * Those with abnormal gastrointestinal findings in physical examination and para-clinical investigations
Where this trial is running
Tehran
- Sina Hospital — Tehran, Iran (RECRUITING)
Study contacts
- Principal investigator: Raika Jamali, M.D. — Professor
- Study coordinator: Raika Jamali, Professor
- Email: jamalira@tums.ac.ir
- Phone: +98-21-63120000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dyspepsia Chronic, Efficacy, Clinical trial, Functional Dyspepsia, questionnaire, Digestive Aid