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Symptoms and Physiological Effects of Amara in Functional Dyspepsia

NCT05553587 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-10

No results posted yet for this study

Summary

The primary aim of this investigator-initiated, prospective, open-label study is to assess perceived changes in symptom burden reported by in patients with functional dyspepsia treated with Amara. Additionally, the physiological effects of Amara on gastric motor and sensory function will be assessed using validated methods.

Conditions

  • Dyspepsia

Interventions

DRUG

Amara drops

The investigational drug is approved with a reduced dossier without indication according to Art. 25 para. 1 KPAV (SR 812.212.24). This study follows the indication text licensed by Swissmedic: "… Weleda Amara-Drops can be used for digestive complaints such as heartburn, flatulence and bloating after meals, to stimulate the bile flow and for loss of appetite and nausea. The effect of Weleda Amara drops is based on a balanced mixture of medicinal plants with tonic (invigorating) and aromatic bitter substances, which are suitable for stimulating digestion." Further, no side effects have been reported in past studies so far. All these reasons lead us to the conclusion that this study is only associated with minimal risks and should be classified in risk category A.

Sponsors & Collaborators

  • Mark Fox

    lead OTHER

Principal Investigators

  • Mark Fox, MD MA · Lead Physician

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2025-02-28
Completion
2025-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553587 on ClinicalTrials.gov