Functional Dysphonia
Conditions
Brief summary
This multicenter, prospective, randomized, controlled clinical trial aims to evaluate the efficacy of a nutraceutical treatment containing highly standardized extracts of ginger (Zingiber officinale) and perilla (Perilla frutescens) (Dispepril®, Pharmextracta S.p.A. Pontenure, Italy) in improving gastric and intestinal symptoms in adults with functional dyspepsia. The study will assess the non-inferiority of Dispepril® compared with standard proton pump inhibitor (PPI) therapy in reducing postprandial distress symptoms. Participants will be randomized in a 2:1:1 ratio to receive Dispepril® alone, Dispepril® plus half-dose PPI, or full-dose PPI for 14 days. Efficacy will be assessed using the Leuven Postprandial Distress Scale (LPDS), together with evaluations of treatment tolerability, adherence, and adverse events.
Detailed description
Functional dyspepsia (FD) is a common disorder of gut-brain interaction characterized by chronic or recurrent upper gastrointestinal symptoms in the absence of an identifiable organic cause. Typical symptoms include postprandial fullness, early satiety, epigastric pain, epigastric burning, upper abdominal bloating, belching, nausea, and heartburn. FD is associated with impaired quality of life and significant healthcare burden. Current management strategies include proton pump inhibitors (PPIs), eradication of Helicobacter pylori when present, and prokinetic therapies. However, treatment efficacy is often limited, and long-term pharmacological therapy may be associated with adverse effects. Dispepril® is a food supplement containing a highly standardized extract of Zingiber officinale titrated in gingerols and shogaols together with a patented bi-fractionated extract of Perilla frutescens. Ginger has been reported to normalize gastric emptying and improve dyspeptic symptoms, while perilla may exert prokinetic and anti-dyspeptic effects through actions on gastrointestinal motility. This multicenter, prospective, randomized, controlled clinical trial will evaluate the efficacy of Dispepril® in adults diagnosed with functional dyspepsia according to Rome IV criteria. Approximately 400 participants will be enrolled and randomized in a 2:1:1 ratio into one of three treatment groups: Dispepril® alone (two gastro-protected tablets daily for 14 days); Half-dose PPI once daily plus Dispepril® (two tablets daily for 14 days); Full-dose PPI once daily for 14 days. The primary objective is to evaluate the non-inferiority of Dispepril® compared with PPI therapy in reducing postprandial distress symptoms. Efficacy will be assessed using the validated Leuven Postprandial Distress Scale (LPDS) at baseline and after 14 days of treatment. Secondary objectives include evaluation of the synergistic activity of Dispepril® combined with half-dose PPI, assessment of treatment effects on individual LPDS gastrointestinal symptom items, treatment tolerability, therapeutic adherence, and adverse events. The total duration of participation for each subject will be 14 days, with assessments performed at baseline (Day 0) and at the end of treatment (Day 14).
Interventions
DIETARY_SUPPLEMENTDispepril® (Pharmextracta S.p.A. Pontenure, Italy)
Dispepril® is a gastro-protected dietary supplement containing 300 mg of highly standardized Zingiber officinale extract titrated to 10% gingerols and shogaols and 150 mg of a patented bi-fractionated Perilla frutescens extract per tablet.
COMBINATION_PRODUCTHalf-Dose PPI Plus Dispepril®
Participants will receive a half-dose proton pump inhibitor once daily together with Dispepril® administered as two gastro-protected tablets daily for 14 consecutive days.
DRUGFull-Dose Proton Pump Inhibitor
Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.
Sponsors
Liaquat University of Medical & Health Sciences
University of Urbino "Carlo Bo"
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Participants and investigators are aware of the assigned intervention. Outcome assessments are performed using the Leuven Postprandial Distress Scale (LPDS).
Intervention model description
Participants will be randomized in a 2:1:1 ratio to one of three parallel treatment groups: Dispepril® alone, Dispepril® plus half-dose proton pump inhibitor (PPI), or full-dose PPI. Participants will remain in their assigned treatment group throughout the 14-day treatment period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participants aged 18 to 65 years * Diagnosis of functional dyspepsia according to Rome IV criteria * Willingness and ability to provide written informed consent * Ability to follow study product administration instructions * Ability to attend scheduled study visits
Exclusion criteria
* Gastrectomy * Cancer * Use of NSAIDs, cholagogues, or tricyclic antidepressants within 30 days prior to enrollment * Helicobacter pylori positivity * Alcoholism or other substance abuse * Hepatic disease * Renal disease * History of hypersensitivity to formulation active ingredients or excipients * Pregnancy or breastfeeding * Participation in another clinical trial or completion of another clinical trial within 1 month prior to enrollment * Refusal or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-Prandial Distress Assessed by the Leuven Postprandial Distress Scale (LPDS) Distress Compared to PPIs | 14 days | Change in post-prandial distress from baseline to Day 14, assessed using the validated Leuven Postprandial Distress Scale (LPDS). The LPDS consists of 8 items assessing postprandial fullness, early satiety, upper abdominal bloating, epigastric pain, epigastric burning, belching, nausea, and heartburn. Each item is rated on a scale from 0 to 4, where 0 indicates no symptom and 4 indicates a very severe symptom. The LPDS has a maximum total score of 32 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Individual Gastrointestinal Symptoms Assessed by the Leuven Postprandial Distress Scale | 14 days | Change from baseline to Day 14 in the individual symptom scores assessed using the Leuven Postprandial Distress Scale (LPDS). The LPDS consists of 8 items evaluating postprandial fullness, early satiety, upper abdominal bloating, epigastric pain, epigastric burning, belching, nausea, and heartburn. Each item is scored from 0 to 4, where 0 indicates no symptom and 4 indicates a very severe symptom. Individual symptom scores range from 0 to 4, with higher scores indicating more severe symptoms and worse outcomes. Changes in individual symptom scores will be compared among treatment groups. |
| Evaluation of the Efficacy of Treatments on Individual Gastrointestinal Symptoms | 14 days | Efficacy of treatments in the various study groups on the individual items of gastrointestinal symptomatology of the Leuven Postprandial Distress Scale (LPDS), assessed at the beginning and end of treatment. |
| Treatment Tolerability Assessed by Investigator Clinical Evaluation | 14 days | Treatment tolerability at Day 14 as assessed by the investigator during the final clinical evaluation. The outcome will be reported as the number and percentage of participants considered to have tolerated treatment without clinically significant safety concerns. |
| Therapeutic Adherence | 14 days | Therapeutic adherence will be assessed at Day 14 by counting returned unused tablets and comparing the number of tablets taken with the number prescribed. The outcome will be reported as the percentage of prescribed tablets taken during the 14-day treatment period. |
| Incidence of Treatment-Emergent Adverse Events | 14 days | Number and percentage of participants experiencing one or more treatment-emergent adverse events during the 14-day treatment period. Adverse events will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE). |
Countries
Italy
Outcome results
None listed