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Efficacy and safety of Aurantii Fructus Immaturus Flavonoid Tablets compared with Domperidone in Functional Dyspepsia: A phase III, multicenter, double-blind, double-dummy, randomized, positive drug-controlled trial

A Phase III Positive Drug-Controlled Clinical Trial of Aurantii Fructus Immaturus Flavonoid Tablets

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083076
Enrollment
Unknown
Registered
2024-04-15
Start date
2013-04-24
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Functional dyspepsia

Interventions

The intervention group:Aurantii Fructus Immaturus Flavonoid Tablets + placebo of Domperidone
The control group:Domperidone + placebo of Aurantii Fructus Immaturus Flavonoid Tablets

Sponsors

Jiangsu Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age= 18 years old, = 65 years old, gender is not limited; 2)Volunteer to participate and sign an informed consent form; 3) Meet the diagnostic criteria for functional dyspepsia; 4) Other gastric prokinetic drugs, gastric mucosal protectors, or antacids have been discontinued 4 weeks prior to enrollment.

Exclusion criteria

Exclusion criteria: 1) Patients with esophagitis, atrophic gastritis, gastric and duodenal ulcers, erosions, hemorrhages, tumors and other organic lesions; 2) Patients with hepatobiliary and pancreatic organic diseases; 3) Diabetes, kidney disease, connective tissue disease, mental illness; 4) Patients with serious primary diseases such as heart, brain, lung, kidney, hematopoietic system, endocrine system, etc.; 5) Those with a history of abdominal surgery; 6) Patients with renal insufficiency, Cr higher than the upper limit of normal; 7) Patients with hepatic insufficiency, AST or/and ALT at 1.5 times the upper limit of normal; 8) Pregnant or expecting to become pregnant, lactating women; 9) Mentally or legally disabled patients; 10) Those who participated in other drug clinical trials within 3 months before the trial.

Design outcomes

Primary

MeasureTime frame
The disappearance rate of all four symptoms of functional dyspepsia;

Secondary

MeasureTime frame
The disappearance rate of all four symptoms of functional dyspepsia;The disappearance rate of single symptoms of functional dyspepsia ; Gastric emptying rate and emptying time;

Countries

China

Contacts

Public ContactMuxin Wei

Jiangsu Provincial People's Hospital

weimuxin@njmu.edu.cn+86 139 5209 3826

Outcome results

None listed

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