An interventional study of Dispepril® (Pharmextracta S.p.A. Pontenure, Italy) and Half-Dose PPI Plus Dispepril® in Functional Dysphonia, sponsored by Liaquat University of Medical & Health Sciences. Not yet recruiting at 4 sites in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Treatment
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.
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).
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 400 is above the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Dispepril®, administered as two gastro-protected tablets daily for 14 consecutive days. One tablet will be taken approximately 15 minutes before lunch and one tablet approximately 15 minutes before dinner. Each tablet contains 300 mg of highly standardized Zingiber officinale extract and 150 mg of a patented bi-fractionated Perilla frutescens extract.
Dietary Supplement: Dispepril® (Pharmextracta S.p.A. Pontenure, Italy)
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. One tablet will be taken approximately 15 minutes before lunch and one tablet approximately 15 minutes before dinner.
Combination Product: Half-Dose PPI Plus Dispepril®
Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.
Drug: Full-Dose Proton Pump Inhibitor
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.
Also known as: Ginger Extract, Perilla Extract
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.
Also known as: PPI + Dispepril®
Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.
Also known as: Full-Dose PPI
Change in Post-Prandial Distress Assessed by the Leuven Postprandial Distress Scale (LPDS) Distress Compared to PPIs
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.
Time frame: 14 days
Change in Individual Gastrointestinal Symptoms Assessed by the Leuven Postprandial Distress Scale
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.
Time frame: 14 days
Evaluation of the Efficacy of Treatments on Individual Gastrointestinal Symptoms
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.
Time frame: 14 days
Treatment Tolerability Assessed by Investigator Clinical Evaluation
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.
Time frame: 14 days
Therapeutic Adherence
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.
Time frame: 14 days
Incidence of Treatment-Emergent Adverse Events
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).
Time frame: 14 days
Plan to share: No
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Liaquat University of Medical & Health Sciences