The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia

NCT06313814 | Enrolling By Invitation DMC

• 1 other identifier: DE RKEB/IKEB 5622-2020
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess ginger's effect on patients with functional dyspepsia. The main question\[s\] it aims to answer are:

1. 1.Does ginger intake improve functional dyspepsia symptoms?
2. 2.Does ginger intake decrease the body fat content among patients with functional dyspepsia? Dyspepsia patients will be asked to take 540 mg of ginger capsule twice a day. Researchers will assess if there is an improvement in the symptoms of the disease and the fat content. \[ to see if gingers effect.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (2)

• Functional Dyspepsia Symptom Severity

  This study will evaluate and measure the expected improvements in functional dyspepsia symptoms. It will be assessed by the Nepean Dyspepsia Index (NDI) questionnaire, among 62 patients with functional dyspepsia treated with ginger supplementation compared to the baseline, by the end of the four-week intervention. This measure focuses on the reduction in symptoms such as pain, discomfort, bloating, and early satiety. Each item on the Nepean Dyspepsia Index questionnaire is usually scored on a Likert scale, with higher scores representing more severe symptoms or greater impairment. I.e. Higher scores on the Nepean Dyspepsia Index indicate more severe dyspeptic symptoms and a greater impact on quality of life. Lower scores indicate milder symptoms and less impairment in quality of life. Therefore, a reduction in Nepean Dyspepsia Index scores in response to ginger supplementation indicates an improvement in symptoms and quality of life for individuals with dyspepsia.

  four weeks

• Body Fat Content Analysis

  Changes in body fat content, which will be assessed before and after four weeks of ginger supplementation using the In-Body 270, a non-invasive device that measures body weight, skeletal muscle mass, body fat, and other health parameters at five body parts using two different frequencies. This measure aims to evaluate the impact of Functional Dyspepsia and ginger supplementation on body composition, which could be relevant due to potential associations between functional dyspepsia and alterations in body fat distribution.

  Four weeks

Secondary Outcomes (1)

• Improvement in Quality of Life

  Four weeks

Study Arms (1)

before and after result comparison

OTHER

we will see if there is an effect after the intervention. we will measure the before and after signs.

Dietary Supplement: Swanson ginger capsule

Interventions

Swanson ginger capsule DIETARY_SUPPLEMENT

Swanson Ginger Root? gingerols, shogaols, and paradols, and possesses multiple bioactivities, such as antioxidant, anti-inflammatory, and antimicrobial properties. Ginger is most commonly associated as a culinary spice flavouring to oriental dishes and even the local bakery character biscuit, the gingerbread man. But since ancient times the spice has also been recognized for its health properties, most popular being to settle the stomach, alleviate indigestion and event prevent motion sickness. More recently research has confirmed Ginger's historical effectiveness on digestive health and beyond.

before and after result comparison

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from Functional dyspepsia symptoms

You may not qualify if:

• Patients with relevant gastroesophageal reflux symptoms (retrosternal pain, burning, or regurgitation) as well as patients with clear evidence of irritable bowel syndrome will not be included. Patients under treatment with pharmacological substances that could influence the gastrointestinal system, such as prokinetics, ursodeoxycholic acid (UDCA), nonsteroidal anti-inflammatory drugs (NSAIDs), cholagogues, protonpump inhibitors, and H2 blockers, will be asked to interrupt this treatment for one month before starting the study treatment.
• Moreover, patients with a previous diagnosis of cancer or with previous surgery of the upper gastrointestinal tract or of the biliopancreatic system (except for cholecystectomy) and patients with active HP infection or with gastric or duodenal ulcer, as well as pregnant women, will be excluded.

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen

Debrecen, 4032, Hungary

Location

Related Publications (1)

• Aregawi LG, Zoltan C. Evaluation of Adverse Effects and Tolerability of Dietary Ginger Supplementation in Patients With Functional Dyspepsia. Curr Ther Res Clin Exp. 2025 Apr 14;102:100792. doi: 10.1016/j.curtheres.2025.100792. eCollection 2025.

  PMID: 40474983 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 15, 2024
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)