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Randomized, double-blind, double-simulated, parallel controlled trial for effects of Wang Baochi Pill in the treatment of functional dyspepsia

Randomized, double-blind, double-simulated, parallel controlled trial for effects of Wang Baochi Pill in the treatment of functional dyspepsia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026288
Enrollment
Unknown
Registered
2019-09-29
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

functional dyspepsia

Interventions

Control group:mosapride citrate tablets
Experimental group:Wang Baochi Pill

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-65 years old male and female, outpatient; (2) There were symptoms of postprandial distension and early satiety, which met the diagnostic criteria of Roman IV functional gastrointestinal diseases. At least one score (degree + frequency) was greater than 4; (3) Gastroscopy was performed within 3 months before admission, and chronic non-atrophic gastritis was diagnosed; (4) C 13 or C 14 breath test was performed to detect the negative Helicobacter pylori within 3 months before enrollment; (5) agree to participate in this clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Epigastric pain syndrome (EPS) is the main symptom, and there is at least one score (degree + frequency) > 4 for mid-upper abdominal pain or burning sensation of mid-upper abdomen; (2) Patients with organic digestive tract diseases such as reflux esophagitis, peptic ulcer, digestive tract tumors, etc.; (3) suffering from thyroid disease, systemic sclerosis, systemic lupus erythematosus, chronic cholecystitis, cholecystolithiasis and other serious hepatobiliary and pancreatic diseases; or considering the possibility of intestinal obstruction; (4) Patients with severe mental disorders (HAD scale score (> 8); (5) Drugs affecting gastrointestinal motility or gastric acid secretion, neutralizing gastric acid and anti-Helicobacter pylori drugs were used within 1 week before enrollment; (6) When ALT and AST are 1.5 times higher than the normal value, the total bilirubin is 1.5 times higher than the upper limit of the normal value, and creatinine is higher than the upper limit of the normal value; (7) Patients with diabetes, epilepsy and cognitive language disorders; (8) Acupuncture and moxibustion, Qigong and other non-drug treatment; (9) Suspicion or clear history of drug and alcohol abuse; (10) allergic to Wang's Baochi Pill and its components; (11) Pregnant women, lactating women or planned pregnancies; (12) Abnormal electrocardiogram with clinical significance such as arrhythmia or abnormal Q wave, prolonged QT interval, etc.; (13) Those who have participated in other clinical trials in the past three months; (14) Researchers do not think it is suitable for the group.

Design outcomes

Primary

MeasureTime frame
Improvement rate of main symptoms;

Countries

China

Contacts

Public ContactZhao shen LI

Shanghai Changhai Hospital

duyiqi@hotmail.com+86 13801993592

Outcome results

None listed

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