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A multi-centre randomized controlled trial: Combizym in the prevention of aged functional dyspepsia.

A multi-centre randomized controlled trial: Combizym in the prevention of aged functional dyspepsia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008023
Enrollment
Unknown
Registered
2016-02-29
Start date
2016-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Aged Functional Dyspepsia.

Interventions

Control group:With domperidone 2 weeks, 10mg/per, tid, and 4weeks followed up.
The treatment group A:With Combizym 2 weeks, two pills each time, tid, and 4weeks followed up.
The treatment group B:The treatment group B were based on the same treatment of control group plus Combizym. During or after a meal to swallow, and 4weeks followed up.

Sponsors

CHINESE PLA GENERAL HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. All genders aged >=65; 2. Include three or more indigestion symptoms ,such as epigastric painabdominal discomfort epigastrium burn feelheartburnabdominal spastic pain chest paincan't eat regularlyreflux postprandial fullness slow digestionabdominal oppressing sensationabdominal flatulenceearly satiety nausea belchingvomiting and bad breath. And there are no organic disease to explain; 3. Symptoms above >=6m before diagnose, and meets these criteria >=3m.

Exclusion criteria

Exclusion criteria: 1. Patients with severe liver, gallbladder, pancreas disease; 2. patients with chronic constipation; 3. The stomach contains organic disease, such as ulcer, tumor(within 6M); 4. Complicated with pregnancy lactationdiabetes malignant tumor, and serious heart, lung, and nephropathy. 5. Patients with history of abdominal operation, or neuropsychic diseases, the crowd with limited activity, and so on; 6. Clinical Research Physicians consider patients with unstable condition,and will affect the study effect evaluation; 7. Patients participated in other clinical studies within 4 weeks; 8. Patients was areadly addictive with or need to take other drugs in treating dynamic disturbancedyspepsi. That would effect experiment result; 9. Patients are sensitive with study drugs.

Design outcomes

Primary

MeasureTime frame
Epigastric pain;Epigastric discomfort;Burning in epigastrium;Heartburn;Abdominal spastic pain;Chest pain;Can't eat regularly;Reflux;Postprandial fullness or slow digestion;Epigastrium oppressing sensation;Epigastrium flatulence;Early satiety;Nausea;Belching;Vomiting;Bad breath;

Countries

China

Contacts

Public ContactWu Benyan
wanggangshi301@163.com+86 13671115596

Outcome results

None listed

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