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

ConditionPancreatic Cancer

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-80

SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

Exploratory evaluation comparing the addition of Shouhui Constipation Capsules to standard pancreatic enzyme therapy for improving exocrine pancreatic function in patients after pancreaticoduodenectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Shouhui Tongbian Capsules
Drug
Shouhui Tongbian Capsules are taken orally, 2 capsules per dose, 3 times daily;Pancreatin enteric-coated capsules are administered at the clinically conventional dosage; for a continuous period of 12 weeks.
Pancreatin Enteric-Coated Capsules
Drug
Pancreatin enteric-coated capsules are administered at the clinically conventional dosage,for a continuous period of 12 weeks.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: experimental groupExperimental treatment 2 interventions

Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Improvement effect on pancreatic exocrine function

Change in fecal elastase-1 concentration (μg/g) from baseline to Week 12

Time frame

12 weeks after treatment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: