Assessing the effects of Amara on symptoms of functional dyspepsia
Perceived Changes in Symptom Burden and Physiological Effects of a Proprietary Phyto-therapeutic Preparation (Amara) in Patients with Functional Dyspepsia: Prospective Study As Investigator Initiated Trial (IIT)
PHASE4 · Klinik Arlesheim · NCT05553587
This study is testing if a herbal treatment called Amara can help adults with functional dyspepsia feel better by reducing their symptoms.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Klinik Arlesheim (other) |
| Locations | 1 site (Arlesheim, Basel Land) |
| Trial ID | NCT05553587 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the impact of Amara, a phytotherapy, on symptom relief in patients suffering from functional dyspepsia. It will involve a prospective, open-label design where participants will report changes in their symptom burden. Additionally, the study will assess the physiological effects of Amara on gastric motor and sensory functions using validated methodologies. The target population includes adults aged 18 to 75 with moderate to severe dyspeptic symptoms as defined by the Rome IV criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with functional dyspepsia and experiencing moderate to severe symptoms.
Not a fit: Patients with acute life-threatening conditions, significant psychiatric comorbidities, or advanced liver or kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective natural treatment option for patients with functional dyspepsia who are intolerant to conventional medications.
How similar studies have performed: Previous studies have shown promise with herbal therapies for functional dyspepsia, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred by their treating physician to the Center for integrative Gastroenterology at the Clinic Arlesheim * Age over 18 years and ≦75 years of age * Patients with Diagnosis of Functional Dyspepsia with Postprandial Distress (Rome IV criteria) with Leuven Dyspepsia Score "at least moderate" severity (\>=10/20) * Signed informed consent * No change in medical treatment during the previous 1 month (e.g., proton pump inhibitor, antidepressants) during the last one month or for the duration of the period * Good German knowledge (at least level B2 from Common European Framework of Reference for Languages) Exclusion Criteria: * Acute life-threatening conditions * Withdrawal of informed consent * Clinically relevant psychiatric comorbidity (HADS score \>11) * Advanced liver (Child score \> 6) or kidney disease (GFR \< 60) * History of abdominal surgery except appendectomy * Allergy to any component of Amara * Pregnancy and lactation
Where this trial is running
Arlesheim, Basel Land
- Klinik Arlesheim — Arlesheim, Basel Land, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Mark Fox, MD MA — Lead Physician
- Study coordinator: Mark Prof. Dr. med. Fox, MD MA
- Email: mark.fox@klinik-arlesheim.ch
- Phone: 0041791934795
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, Phytotherapy, Gastric Emptying, Gastric Sensation, Clinical Outcomes Research