MITE in the Treatment of Dyspepsia After Cholecystectomy

Last updated: March 3, 2021
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Not Recruiting

Phase

4

Condition

Heartburn (Pediatric)

Heartburn

Colic

Treatment

N/A

Clinical Study ID

NCT04786795
XHEC-C-2020-049-2
  • Ages 18-70
  • All Genders

Study Summary

To confirm the clinical efficacy of Compound Azintamide Enteric-coated Tablets in the treatment of patients with dyspepsia after cholecystectomy (such as abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite, etc.) by comparing with positive control drug, to observe its safety, and to evaluate the quality of life of subjects before and after treatment

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-70 years old, male or female;
  2. Patients after laparoscopic cholecystectomy, mainly including cholecystectomy due tocholecystitis, gallstones, gallbladder polyps and other benign gallbladder tumors,non-functioning gallbladder;
  3. Dyspeptic symptoms occurred 2 weeks after laparoscopic cholecystectomy, including:abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, earlysatiety, belching, loss of appetite;
  4. Signed informed consent, agreed to participate in this study.

Exclusion

Exclusion Criteria:

  1. Patients with abnormal liver function and renal function;
  2. Patients with severe heart and lung dysfunction;
  3. Patients with neurological, mental illness or other reasons can not cooperate with thestudy;
  4. Patients with advanced malignant tumors or other serious wasting diseases, anyunstable chronic diseases and acute diseases, interfere with the efficacy evaluationof this study (such as patients undergoing chemotherapy) and the completion of thetrial plan;
  5. Patients with biliary obstruction, acute hepatitis, etc., do not use the test drugsand control drugs, and allergic to the test drugs and control drugs;
  6. Patients who have taken digestive enzymes and cholagogue drugs by themselves;
  7. Pregnant and lactating women;
  8. Patients who are participating in other clinical trials;
  9. Patients who cannot be followed up on time. Elimination Criteria
  10. Failure to take medicine as required, that is,Failure to take medicine or missed doses ≥ 3 times within 1week;
  11. Taking other digestive enzymes, cholagogues and prokinetic drugs or drugs affectingdigestive enzymes and bile secretion and excretion during the study;
  12. Adverse events occur, for the benefit of patients, doctors believe that the drugshould not be continued; the results of such cases do not participate in the efficacystatistics, but are related to the safety evaluation. Drop-out Criteria
  13. Cases with adverse events and patients are not willing to continue participating inthe study.
  14. Cases who voluntarily withdrew consent from the study due to poor efficacy andinconvenience in follow-up.
  15. cases lost to follow-up due to various reasons.

Study Design

Total Participants: 990
Study Start date:
March 01, 2021
Estimated Completion Date:
February 28, 2022

Study Description

This study is a multi-center, randomized, superiority and parallel controlled clinical study. Third-party institutions will generate random codes according to random numbers of the software and divide them into two groups (Compound Azintamide Enteric-coated Tablets Group, Oryz-aspergillus Enzyme and Pancreatin Tablet and Ursodeoxycholic Acid Tablets Group) in a ratio of 1:1. Random numbers will be sealed and stored in radiopaque envelopes, which will be managed by a designated person not involved in the specific study.

Specific intervention measures: If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets, and the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit