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
Starting soon · Phase 4
Conditions studied: Pancreatic Cancer
In brief
Exploratory evaluation comparing the addition of Shouhui Constipation Capsules to standard pancreatic enzyme therapy for improving exocrine pancreatic function in patients after pancreaticoduodenectomy.
Key facts
- Study ID
- NCT07557394
- Run by
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- People needed
- 80
- Starts
- 2026-05-01
- Expected to finish
- 2028-04-30
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 18-80 years old;
- Pathologically confirmed pancreatic cancer and underwent pancreaticoduodenectomy(involved removing 50% of the pancreas, leaving 50% of the pancreas, ensuring balanced grouping);
- Presence of EPI symptoms (such as steatorrhea) and/or constipation (Bristol type 1-2, with <3 bowel movements per week);
- Have informed consent and be proficient in using smartphone apps;
- Patients who are intended to receive treatment with either Daitong Capsules or Shouhui Tongbian Capsules, or both;
- The patient's condition is stable and suitable for participation in this study, as confirmed by investigator;
- Willing and able to follow the medication and follow-up plan specified in the study protocol, with an expected medication adherence rate of over 80%.
You may not qualify if…
- Allergic to pancreatic enzyme (porcine-derived protein allergy) or any ingredient of Shouhui Tongbian Capsules;
- Have a history of liver damage caused by Polygonum multiflorum;
- Combined with intestinal obstruction, severe hepatic and renal insufficiency (Child-Pugh Class C, eGFR < 30 ml/min), etc;
- Pregnant or lactating women;
- Psychological cognitive impairment.
- It is expected that the 12-weeks follow-up will not be completed.
Full record on ClinicalTrials.gov
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