Functional DysphoniaNCT07655219
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 study testing Dispepril® (Pharmextracta S.p.A. Pontenure, Italy), Half-Dose PPI Plus Dispepril® and Full-Dose Proton Pump Inhibitor in people with Functional Dysphonia, run by Liaquat University of Medical & Health Sciences at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dysphonia
- What is being tested?
- Dispepril® (Pharmextracta S.p.A. Pontenure, Italy), Half-Dose PPI Plus Dispepril® and Full-Dose Proton Pump Inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesItaly
- Study dates
- 22 Jun 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites
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
About this study
Official title: 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
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.
Read the 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).
- Conditions
- Functional Dysphonia
- Being tested
- Dispepril® (Pharmextracta S.p.A. Pontenure, Italy), Half-Dose PPI Plus Dispepril®, Full-Dose Proton Pump Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dispepril® (Pharmextracta S.p.A. Pontenure, Italy)Dietary supplement
Also called Ginger Extract, Perilla Extract
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.
Half-Dose PPI Plus Dispepril®Combination product
Also called PPI + 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.
Full-Dose Proton Pump InhibitorDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Dispepril® | Experimental | 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. Receives: Dietary Supplement: Dispepril® (Pharmextracta S.p.A. Pontenure, Italy) |
| Half-Dose PPI Plus Dispepril® | Experimental | 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. Receives: Combination Product: Half-Dose PPI Plus Dispepril® |
| Full-Dose PPI | Active comparator | Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia. Receives: Drug: Full-Dose Proton Pump Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DysphoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655219
- Sponsor's protocol ID
- 170_31marzo 2026_DISPEPRIL
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07655219
- Acronym / sponsor ID
- 170_31marzo 2026_DISPEPRIL
- Conditions
- Functional Dysphonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dispepril® | Experimental | Dietary Supplement: Dispepril® (Pharmextracta S.p.A. Pontenure, Italy)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. |
| Half-Dose PPI Plus Dispepril® | Experimental | Combination Product: 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. |
| Full-Dose PPI | Active comparator | Drug: Full-Dose Proton Pump InhibitorParticipants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Gastrectomy
- Cancer
- Use of NSAIDs, cholagogues, or tricyclic antidepressants within 30 days prior to enrollment
- Helicobacter pylori positivity
- Alcoholism or other substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dispepril® (Pharmextracta S.p.A. Pontenure, Italy)Also: Ginger Extract, Perilla ExtractDispepril® 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. | Dietary supplement | Dispepril® |
| Half-Dose PPI Plus Dispepril®Also: PPI + 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. | Combination product | Half-Dose PPI Plus Dispepril® |
| Full-Dose Proton Pump InhibitorAlso: Full-Dose PPIParticipants 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 PPI |
Primary outcome
Change in Post-Prandial Distress Assessed by the Leuven Postprandial Distress Scale (LPDS) Distress Compared to PPIs
Time frame: 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.
5 secondary outcomes
Change in Individual Gastrointestinal Symptoms Assessed by the Leuven Postprandial Distress Scale
Time frame: 14 days
Evaluation of the Efficacy of Treatments on Individual Gastrointestinal Symptoms
Time frame: 14 days
Treatment Tolerability Assessed by Investigator Clinical Evaluation
Time frame: 14 days
Therapeutic Adherence
Time frame: 14 days
Incidence of Treatment-Emergent Adverse Events
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dispepril® (Pharmextracta S.p.A. Pontenure, Italy), Half-Dose PPI Plus Dispepril® and Full-Dose Proton Pump Inhibitor in people with Functional Dysphonia, run by Liaquat University of Medical & Health Sciences at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Prandial Distress Assessed by the Leuven Postprandial Distress Scale (LPDS) Distress Compared to PPIs (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.