A Study on the Efficacy of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery
NCT07751367 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-08-07
Summary
This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based medicine and promote standardized treatment.
Conditions
- Pancreatic Exocrine Insufficiency, Adul
Interventions
- DRUG
-
High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet
High-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet, 5 tablets each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days);
- DRUG
-
Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet
Low-dose group: Oral study drug:Oryz-Aspergillus Enzyme And Pancreatin Tablet, 1 tablet each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days).
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-18
- Primary Completion
- 2028-07-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
More Related Trials
-
Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes
NCT07512934 ·Status: RECRUITING
-
A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors
NCT05453851 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
NCT02985801 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Exocrine Pancreatic Insufficiency After Acute Pancreatitis and Pancreatic Enzyme Replacement Therapy
NCT05480241 ·Status: UNKNOWN ·Phase: NA
-
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
NCT06477159 ·Status: RECRUITING ·Phase: PHASE4
-
Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Supplementation in Critically Ill Adult Patients
NCT01753024 ·Status: COMPLETED
-
A Prospective Non-randomized Controlled Interventional Study on the Effect of Shouhui Tongbian Capsules Combined With Pancreatin Enteric-coated Capsules on Pancreatic Exocrine Function in Patients After Curative Resection for Pancreatic Cancer
NCT07557394 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests
NCT06006312 ·Status: UNKNOWN
-
Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control
NCT00744250 ·Status: TERMINATED ·Phase: PHASE4
-
PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
NCT05466838 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis
NCT07314489 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
NCT03501680 ·Status: UNKNOWN ·Phase: PHASE4
-
Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
NCT05251233 ·Status: TERMINATED ·Phase: PHASE2
-
Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
NCT00705978 ·Status: COMPLETED ·Phase: PHASE3
-
Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer
NCT04315311 ·Status: WITHDRAWN ·Phase: PHASE4
-
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
NCT02370537 ·Status: COMPLETED ·Phase: PHASE2
-
PERT in Acute Necrotizing Pancreatitis
NCT07211568 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors
NCT07360119 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effectiveness of Pancreatic Enzymes in Patients Pancreatic Insufficient: Comparison of Two Drugs
NCT01228643 ·Status: WITHDRAWN ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
NCT00297167 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) to Endoscopic Pancreatic Function Test (ePFT) in Diagnosing Pancreatic Exocrine Insufficiency
NCT01094600 ·Status: WITHDRAWN ·Phase: NA
-
Post Acute Pancreatitis Pancreatic Exocrine Insufficiency
NCT03063398 ·Status: COMPLETED
-
The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy
NCT02127021 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.
NCT07559175 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis
NCT06946108 ·Status: COMPLETED