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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compound Azintamide Enteric-coated Tablets | Experimental | If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit. |
|
| Oryz-aspergillus Enzyme | Placebo Comparator | If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Azintamide Enteric-coated Tablets | Drug | the experimental group takes Compound Azintamide Enteric-coated Tablets.They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom assessment | scored according to the severity of symptoms. severity: 0 : asymptomatic.
| 28days |
| Efficacy evaluation | symptom score improvement rate = (symptom score before treatment - symptom score after treatment)/symptom score before treatment × 100%. Significantly effective: symptom score improvement rate > 75%. Effective: symptom score improvement rate 50% ~ 75% (including 50%). Improvement: symptom score improvement rate of 25% ~ 50% (including 25%). Ineffective: symptom score improvement rate < 25%. Worsening: The symptom score increased after medication. Overall response rate = (number of effective cases + number of significantly effective cases)/total number of cases × 100%. | 28days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AE) | Serious adverse events (SAE), such as death or life-threatening, hospitalization or prolonged hospitalization, severe disability or severely impaired organ function, etc. Adverse reaction symptoms are recorded in three levels: mild, moderate and severe, and may be related, may not be related, definitely related, and definitely not related. Mild adverse reactions: The symptoms of adverse reactions are mild and can only be remembered after a doctor's inquiry; severe adverse reactions: the main complaints of adverse reactions are strong, affecting the patient's daily life or the continuation of research; moderate adverse reactions: the severity of adverse reactions is moderate Between degree and severe. Adverse reactions include any new complaints of discomfort during the study period. If symptoms only worsen during the study, it is not considered an adverse event. Any adverse events should be actively handled |
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Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria
Drop-out Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhaohui tang, PhD | Contact | 13601789458 | tangzhaohui@yahoo.com |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets | Drug | 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 |
|
| 28days |
| Quality of life assessment | The SF-NDI scale was used to assess the impact of dyspeptic symptoms on the quality of life of subjects before and after treatment | 28days |
| Pharmacoeconomic evaluation | Pharmacoeconomics includes cost indicators and pharmacoeconomic evaluation indicators that are ultimately used for analysis. Cost indicators include the total direct costs that patients should bear from the start of enrollment to the 28-day follow-up period. From an individual analysis perspective, they include: 1) laboratory inspection costs; 2) medical care and management costs; 3) disease diagnosis costs; 4) The cost of treatment; 5) The cost of treatment of adverse reactions and complications. Pharmacoeconomics evaluation indicators use cost-effectiveness analysis (CEA) to calculate the cost-effectiveness ratio for comparison. | 28days |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |