Symptoms and Physiological Effects of Amara in Functional Dyspepsia

NCT05553587 | Completed Phase 4 DMC

• 1 other identifier: Amara-KLA-01-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Phytotherapy; Gastric Emptying; Gastric Sensation; Clinical Outcomes Research

Outcome Measures

Primary Outcomes (1)

• Dyspeptic Symptoms

  The primary outcome will be the perceived change of dyspeptic symptoms assessed by the Leuven Dyspepsia Questionnaire (LDQ) between visit 2 (off treatment) and 3 (on treatment). It addresses 8 items distributed over five domains. The domains cover a range from 0 (none or absent) to 4(very severe) and assess symptom severity over the preceding 2 weeks. Higher total scores indicate more severe dyspeptic symptoms. The overall score ranges from 0-20 with standardized cut-offs: 0-5, normal to minimal dyspepsia; 6-10, mild dyspepsia; 10-15, moderate dyspepsia; 15-20, severe dyspepsia.

  4 weeks (baseline and after intervention)

Secondary Outcomes (4)

• Gastric Emptying

  4 weeks (baseline and after intervention)

• Visceral Sensitivity

  4 weeks (baseline and after intervention)

• Reflux disease questionnaire (RDQ)

  4 weeks (baseline and after intervention)

• Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS)

  4 weeks (baseline and after intervention)

Other Outcomes (1)

• The validity of the Lüscher Colour Test (LCT)

  4 weeks (baseline and after intervention)

Study Arms (1)

Amara Drops

EXPERIMENTAL

Phytopharmaceutical / therapeutic intervention

Drug: Amara drops

Interventions

Amara drops DRUG

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.

Amara Drops

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark Fox: lead

Study Sites (1)

Klinik Arlesheim

Arlesheim, Basel-Landschaft, 4144, Switzerland

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Fox, MD MA

  Lead Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: prospective, open label, non-randomized study

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: September 23, 2022
• Study Start: July 22, 2022
• Primary Completion: February 28, 2025
• Study Completion: April 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

CH (1)