Skip to content

A real-world study of the efficacy and safety of Pancreatin Enteric-Coated Capsules in the treatment of postpranational discomforts in the elderly

A real-world study of the efficacy and safety of Pancreatin Enteric-Coated Capsules in the treatment of postpranational discomforts in the elderly

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040864
Enrollment
Unknown
Registered
2020-12-12
Start date
2020-11-30
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

Gastrointestinal diseases

Interventions

A:Pancreatin Enteric-coated Capsules
B:Itopril hydrochloride tablets
C:Pancreatin Enteric-coated Capsules and Itopril hydrochloride tablets

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients should meet all the following criteria to participate in the trial: 1. Age 65-85 years old, regardless of gender; 2. To meet the Roman IV diagnostic criteria for PDS, one or two of the following must be included and must be present at least 3 days a week: Post meal fullness and discomfort (so as to interfere with daily activities) Early satiety and discomfort (so as to be unable to complete the usual amount of food); 3. Routine examinations (including gastroscopy) found no evidence of organic, systemic or metabolic diseases that could explain the above symptoms;There may be other organic diseases, but the disease has stabilized or moved into recovery;Symptoms appear at least 6 months before diagnosis, and more than 3 months after diagnosis. 4. Subject should volunteer for the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: 1. Patients with severe liver, gallbladder and pancreatic diseases; 2. Patients with severe constipation recently; 3. Patients with HP positive ; 4. Gastroscopy or imaging examination within the last 6 months (e.g., barium meal examination) suggests that there are organic lesions in the stomach, such as ulcers, tumors, etc.; 5. Patients with diabetes, malignant tumor and severe heart, lung, kidney disease; 6. Patients with a history of abdominal surgery (after pancreatic biliary surgery, after subtotal gastrectomy, incomplete intestinal obstruction) or mental disorders, mobility disabilities (if long bed, etc.); 7. Any chronic or acute disease with unstable condition that the study physician evaluated would affect the efficacy evaluation and completion of the study; 8. Patients who had participated in other clinical studies within 4 weeks before the study; 9. Patients who are already dependent on drugs for the treatment of indigestion, or need to take other drugs for the treatment of indigestion during the experiment, which may interfere with the experimental results; 10. Patients who are allergic to studying drugs or have a history of allergy to similar drugs.

Design outcomes

Primary

MeasureTime frame
Leuven post - meal discomfort Scale;

Secondary

MeasureTime frame
Anxiety and depression Status (GAD-7 and PHQ-9) scales;

Countries

China

Contacts

Public ContactWang Gangshi

Chinese PLA General Hospital

wanggangshi301@163.com+86 13391550438

Outcome results

None listed

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