An interventional study of Swanson ginger capsule in Functional Dyspepsia, sponsored by University of Debrecen. Enrolling by invitation at 1 site in Hungary. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by University of Debrecen · Not applicable, Interventional, and Health services research
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:
Brief description of the study:
Currently, the options for managing functional dyspepsia are limited and far from ideal. Few conducted studies showed that ginger consumption has a therapeutic and preventive effect on functional dyspepsia however, the results were not conclusive. Therefore, this study will try to investigate the effect of ginger supplementation on functional dyspepsia symptoms and body fat content among patients with Functional dyspepsia.
Volunteers with functional dyspepsia 62 participants will be will take as tablets containing 540mg ginger capsule twice a day for four weeks with follow-up. Functional dyspepsia symptoms will be asked before and after the intervention using a questionnaire based on the symptoms of Rome IV criteria, including gastric fullness, early satiety, nausea, vomiting, belching, epigastric pain and heartburn which will be graded through visual analog scales (0- 10 scores) and measured for the body contents.
Method and Materials
Sample size, sample selection:
The study will include 62 volunteers with functional dyspepsia, female and male participants between the ages of 18 and 72 years.
Study design This study is a before-after interventional study of patients with functional dyspepsia who come to internal medicine, at the University of Debrecen.
Initiator of the investigation:
Mrs. Lemlem Gebremariam Aregawi, PhD student in Nutritional sciences Dr. Zoltán Csiki, Supervisor
Executor of the study:
Test site:
University of Debrecen OEC, Institute of Internal Medicine - III. s. Clinic of Internal Medicine
Form and process of the examination:
The examination is performed by a specialist (gastroenterologist) and nutrition student of the Institute of Internal Medicine with the help of section assistants familiar with the in-body measurement to measure body minerals, fat, muscle, water and BMI.
In the case of each person examined, a form is filled in, which is also recorded in electronic form. The results of the physical examination of this participant as well as the measured results will be recorded.
Body composition analyzer (InBody720): Patient requirements to be included: empty stomach, empty bladder, light clothes and no shoes for measurement in the early morning on the body composition analyzer. Patients with a pacemaker or with metal in the body will be excluded from measurement on this instrument.
Dosage: Volunteers will take 540mg of ginger capsule twice a day for four weeks.
Dosage Attached: In a separate dossier for each surveyed consumer, a statement of consent.
Design of the study: before and after the interventional study Study subject: volunteer consumers, men, women (18 - 72 years).
Meals:
Diet intervention- 100% ginger powder ground 540mg capsule twice a day dose will be used: each component is characterized by elevated stability. It is prepared using extraction procedures suitable for ingredients of the health food market. The capsule will be provided free of charge and specifically designed for this study.
All patients will be instructed to take one capsule immediately before starting lunch and dinner. During 30 days before the beginning of the study and the 28 days of intervention treatment, all patients will be asked to avoid the use of prokinetic and antisecretory (H2 receptor inhibitors and proton pump inhibitors) drugs. All patients will be also asked to limit the consumption of alcoholic beverages (less than or equal to two drinks per day).
Study group Study group: 62 FD patients Response variables (Dependent variables)
Task details:
Data analysis method:
Data will be analyzed using SPSS software, version 23.0 (IBM Corp., Armonk, NY, USA). Results will be reported as mean (SD) and median (IQR). The Wilcoxon signed rank test will be used to assess the differences in GI symptoms before and after ginger supplementation. The difference between the concentrations at the given time points (initial concentration) will be calculated, the statistical procedure being the repeat t-test. If the background variables become inhomogeneous, it may be necessary to include covariates in the statistical analysis, in which case covariance analysis will be used. If the normality of the data is not adequate for the test or a normal data distribution cannot be transformed, the non-parametric test will be used. We will examine whether the measured parameters change significantly. The significance level will be set at P = 0.05.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 62 is below the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →University of Debrecen is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
we will see if there is an effect after the intervention. we will measure the before and after signs.
Dietary Supplement: Swanson ginger capsule
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.
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.
Time frame: 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.
Time frame: Four weeks
Improvement in Quality of Life
Improvements in quality of life will be assessed by the EuroQol Group's EQ-5D questionnaire before and after 4 weeks of ginger supplementation. EuroQol Group's EQ-5D consists of 2 main components: 1. Descriptive System: This part evaluates health status across 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression Each is rated on a 3-level scale: 1: No problems to 3: Extreme problems 2. Visual Analog Scale (VAS): Respondents rate on a scale from 0 to 100, where: 0: Represents the worst imaginable health state 100: Represents the best imaginable health state The values for EQ-5D ratings are as follows: For each dimension in the descriptive system, the minimum value is 1 (indicating no problems) and the maximum value is 3 (indicating extreme problems). For the VAS, the minimum value is 0 (worst imaginable health state) and the maximum value is 100 (best imaginable health state).
Time frame: Four weeks
Plan to share: No
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Started Jun 2023 (actual). Primary completion is estimated for Jan 2025, 19 months after the start.
Of 71 non-industry interventional studies with no phase under Dyspepsia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 19 months is close to that.
Counting every sponsor, half of 79 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
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University of Debrecen