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/AClinical Study ID
NCT04786795
XHEC-C-2020-049-2
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18-70 years old, male or female;
- Patients after laparoscopic cholecystectomy, mainly including cholecystectomy due tocholecystitis, gallstones, gallbladder polyps and other benign gallbladder tumors,non-functioning gallbladder;
- Dyspeptic symptoms occurred 2 weeks after laparoscopic cholecystectomy, including:abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, earlysatiety, belching, loss of appetite;
- Signed informed consent, agreed to participate in this study.
Exclusion
Exclusion Criteria:
- Patients with abnormal liver function and renal function;
- Patients with severe heart and lung dysfunction;
- Patients with neurological, mental illness or other reasons can not cooperate with thestudy;
- 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;
- Patients with biliary obstruction, acute hepatitis, etc., do not use the test drugsand control drugs, and allergic to the test drugs and control drugs;
- Patients who have taken digestive enzymes and cholagogue drugs by themselves;
- Pregnant and lactating women;
- Patients who are participating in other clinical trials;
- Patients who cannot be followed up on time. Elimination Criteria
- Failure to take medicine as required, that is,Failure to take medicine or missed doses ≥ 3 times within 1week;
- Taking other digestive enzymes, cholagogues and prokinetic drugs or drugs affectingdigestive enzymes and bile secretion and excretion during the study;
- 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
- Cases with adverse events and patients are not willing to continue participating inthe study.
- Cases who voluntarily withdrew consent from the study due to poor efficacy andinconvenience in follow-up.
- 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