Assessment of the Efficacy of a Highly Standardized Ginger and Perilla Nutraceutical (Dispepril®) in Improving Gastric and Intestinal Symptoms in Patients With Functional Dyspepsia

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Пищевая добавка Dispepril® (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.
• Комбинированный продукт 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.
• Препарат Full-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.

Первичные конечные точки

• Change in Post-Prandial Distress Assessed by the Leuven Postprandial Distress Scale (LPDS) Distress Compared to PPIs [Срок оценки: 14 days]

Вторичные конечные точки (5)

• Change in Individual Gastrointestinal Symptoms Assessed by the Leuven Postprandial Distress Scale [Срок оценки: 14 days]
• Evaluation of the Efficacy of Treatments on Individual Gastrointestinal Symptoms [Срок оценки: 14 days]
• Treatment Tolerability Assessed by Investigator Clinical Evaluation [Срок оценки: 14 days]
• Therapeutic Adherence [Срок оценки: 14 days]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: 14 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 4 центра

• U.O.S.D. Digestive Endoscopy, Interventional and Emergency Unit — Montevarchi
• University of Rome Tor Vergata — Rome
• Gastroenterology Centre — Salerno
• University of Urbino Carlo Bo — Urbino

Идентификаторы

NCT: NCT07655219 · 170_31marzo 2026_DISPEPRIL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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