A multicenter case registration study based on the real world on the treatment of patients with functional dyspepsia postprandial distress syndrome (FD-PDS) with total flavones of Aurantii Fructus.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500102221

Enrollment

Unknown

Registered

2025-05-12

Start date

2025-05-15

Completion date

Unknown

Last updated

2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial distress syndrome of functional dyspepsia

Interventions

Total flavonoids of Fructus Aurantii Immaturus tablets group:None

Total flavonoids of Fructus Aurantii Immaturus tablets combined with prokinetic drugs group:None

Gastric motility drugs group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age >= 18 years old, gender unrestricted; 2) Meeting the Rome IV diagnostic criteria for postprandial distress syndrome of functional dyspepsia; 3) At least one symptom score of postprandial fullness or early satiety >= 4 points in the past week; 4) Voluntary participation in this study.

Exclusion criteria

Exclusion criteria: (1) Those who are allergic to the drug components of total flavonoids of Fructus Aurantii Immaturus or cannot tolerate them; (2) Patients with mental illness and intellectual or language impairments that prevent them from filling out scales or recording their own symptoms; (3) Other situations where the researcher deems the participant unsuitable for this study.

Design outcomes

Primary

Measure	Time frame
The response rate of FD-PDS symptoms after 4 weeks of medication (a 50% decrease in postprandial fullness and early satiety symptom scores compared to the baseline was used as the response criterion);	—

Secondary

Measure	Time frame
The response rates of individual FGIDs symptoms at 4 weeks of treatment and at the end of treatment (a 30% reduction in individual symptom scores from baseline was used as the response criterion);The changes in the scores of individual FGIDs symptoms at 4 weeks of treatment and at the end of treatment compared with the baseline;The disappearance rate of individual FGIDs symptoms at 4 weeks of treatment and at the end of treatment;The response rate and recurrence rate of FD-PDS symptoms and individual FGIDs symptoms 4 weeks after drug withdrawal;Evaluation of defecation;Record all adverse events and serious adverse events, including their occurrence, severity, clinical symptoms, vital signs, electrocardiogram and abnormal laboratory test results;	—

Measure

Time frame

The response rates of individual FGIDs symptoms at 4 weeks of treatment and at the end of treatment (a 30% reduction in individual symptom scores from baseline was used as the response criterion);The changes in the scores of individual FGIDs symptoms at 4 weeks of treatment and at the end of treatment compared with the baseline;The disappearance rate of individual FGIDs symptoms at 4 weeks of treatment and at the end of treatment;The response rate and recurrence rate of FD-PDS symptoms and individual FGIDs symptoms 4 weeks after drug withdrawal;Evaluation of defecation;Record all adverse events and serious adverse events, including their occurrence, severity, clinical symptoms, vital signs, electrocardiogram and abnormal laboratory test results;

—

Countries

China

Contacts

Public ContactXiao Yinglian

The First Affiliated Hospital of Sun Yat-sen University

yinglian_xiao@163.com+86 135 6017 2116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026