Trial · NCT04350346
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Check symptom improvement | 3months (At the first outpatient visit 3months after administration) | The symptom score check should be completed at the first outpatient visit 3 months after administration. Nepean Dyspepsia Index- Korean version will be used to check the patient's indigestion symptoms. The questionnaire contains the following gastrointestinal symptoms How often it happened / how severe the symptoms were / how much it bothered you There are five (or six) answers. Gastrointestinal symptoms included Abdominal pain, Abdominal discomfort, Having a sour stomach, Heart burn, A Spasm of the stomach, Chest pain, Early fullness, Gastric acid reflux, Satiety after eating, pressure in the upper abdomen, Bloating of the upper abdomen, Nausea, Vomiting, Burp, Hard to breathe. The answer can be selected in 5 (6) numbers; from 0 to 4 (5). We will check the total score with the sum of each score. The symptom score is compared before and 3 months after administration. |
| Primary | Changes in serum concentrations of WBC count (10^3/µL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of RBC count (10^6/µL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Hemoglobin (g/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of BUN (mg/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Glucose (mg/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Albumin (g/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Total bilirubin (mg/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Direct bilirubin (mg/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Amylase (U/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Lipase (U/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Sodium (mmol/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Potassium (mmol/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Alkaline phosphate (IU/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Primary | Changes in serum concentrations of Gamma-glutamyltransferase (IU/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | |
| Secondary | Abdominal ultrasound examination - Change of Gallbladder wall thickening | 6months (At the second outpatient visit 6months after administration) | We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks whether the gallbladder wall is thick or not. The ultrasound findings are compared before and 6 months after administration. |
| Secondary | Abdominal ultrasound examination - Gallbladder wall extent | 6months (At the second outpatient visit 6months after administration) | We will check Abdominal ultrasound examination 6months after administration. If the gallbladder wall was thick at the first visit, ultrasound after 6 months checks how thick the gallbladder wall is. The thickness of the gallbladder wall is confirmed by mm from ultrasound findings. The ultrasound findings are compared before and 6 months after administration. |
| Secondary | Abdominal ultrasound examination - Number of gallstones | 6months (At the second outpatient visit 6months after administration) | We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks the number of gallstones. The ultrasound findings are compared before and 6 months after administration. |
| Secondary | Abdominal ultrasound examination - Maximum diameter of gallstones | 6months (At the second outpatient visit 6months after administration) | We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks the maximum diameter of gallstones. The maximum diameter of gallstones is confirmed by mm from ultrasound findings. The ultrasound findings are compared before and 6 months after administration. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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