Assessment of the Efficacy of a Highly Standardized Ginger and Perilla Nutraceutical (Dispepril®) in Improving Gastric and Intestinal Symptoms in Patients With Functional Dyspepsia
Assessment of the Efficacy of a Highly Standardized Ginger and Perilla Nutraceutical (Dispepril®) in Improving Gastric and Intestinal Symptoms in Patients With Functional Dyspepsia: A Multicenter, Randomized, Controlled Clinical Trial
Přehled studie
Postavení
Podmínky
Detailní popis
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).
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Montevarchi, Itálie
- U.O.S.D. Digestive Endoscopy, Interventional and Emergency Unit
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Rome, Itálie
- University of Rome Tor Vergata
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Salerno, Itálie
- Gastroenterology Centre
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Urbino, Itálie
- University of Urbino Carlo Bo
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Dispepril®
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.
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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.
Ostatní jména:
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Experimentální: Half-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.
One tablet will be taken approximately 15 minutes before lunch and one tablet approximately 15 minutes before dinner.
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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.
Ostatní jména:
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Aktivní komparátor: Full-Dose PPI
Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.
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Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Post-Prandial Distress Assessed by the Leuven Postprandial Distress Scale (LPDS) Distress Compared to PPIs
Časové okno: 14 days
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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.
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14 days
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Individual Gastrointestinal Symptoms Assessed by the Leuven Postprandial Distress Scale
Časové okno: 14 days
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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.
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14 days
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Evaluation of the Efficacy of Treatments on Individual Gastrointestinal Symptoms
Časové okno: 14 days
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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.
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14 days
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Treatment Tolerability Assessed by Investigator Clinical Evaluation
Časové okno: 14 days
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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.
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14 days
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Therapeutic Adherence
Časové okno: 14 days
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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.
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14 days
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Incidence of Treatment-Emergent Adverse Events
Časové okno: 14 days
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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).
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14 days
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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