Clinical trial · Interventional

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

NCT07557394CI-TRIAL-00109794not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Pancreatin Enteric-Coated Capsules	Drug	—	UNRESOLVED
Shouhui Tongbian Capsules	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
experimental group
interventionNames
1. Drug: Shouhui Tongbian Capsules
2. Drug: Pancreatin Enteric-Coated Capsules
type
ACTIVE_COMPARATOR
label
control group
interventionNames
1. Drug: Pancreatin Enteric-Coated Capsules

Primary outcomes (1)

measure
Improvement effect on pancreatic exocrine function
timeFrame
12 weeks after treatment
description
Change in fecal elastase-1 concentration (μg/g) from baseline to Week 12

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age: 18-80 years old;
2. Pathologically confirmed pancreatic cancer and underwent pancreaticoduodenectomy(involved removing 50% of the pancreas, leaving 50% of the pancreas, ensuring balanced grouping);
3. Presence of EPI symptoms (such as steatorrhea) and/or constipation (Bristol type 1-2, with \<3 bowel movements per week);
4. Have informed consent and be proficient in using smartphone apps;
5. Patients who are intended to receive treatment with either Daitong Capsules or Shouhui Tongbian Capsules, or both;
6. The patient's condition is stable and suitable for participation in this study, as confirmed by investigator;
7. 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%.

Exclusion Criteria:

1. Allergic to pancreatic enzyme (porcine-derived protein allergy) or any ingredient of Shouhui Tongbian Capsules;
2. Have a history of liver damage caused by Polygonum multiflorum;
3. Combined with intestinal obstruction, severe hepatic and renal insufficiency (Child-Pugh Class C, eGFR \< 30 ml/min), etc;
4. Pregnant or lactating women;
5. Psychological cognitive impairment.
6. It is expected that the 12-weeks follow-up will not be completed.

References

Publications (0)

Data not yet available

No reference posted for this study.