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| Name | Class |
|---|---|
| All Clean Health Co., Ltd | UNKNOWN |
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The objective is to explore the effects of adding AC-134 on renal function, proteinuria, uremic toxins, and metabolism-related markers in chronic kidney disease.
Chronic kidney disease (CKD) management primarily focuses on addressing associated complications such as hypertension, diabetes mellitus, cardiovascular disease, and proteinuria. In addition to standard therapies, reducing the accumulation of toxins, particularly gut-derived uremic toxins like indoxyl sulfate (IS) and p-cresol sulfate (PCS), may help alleviate uremia symptoms. This study assesses the impact of oral AC-134 capsules containing activated charcoal adsorbent on CKD patients. The assessment will include evaluating changes in renal function, proteinuria, uremic toxins, and metabolism-related markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Low-protein diet strategies combined with AC-134 capsules |
|
| Control group | Active Comparator | Low-protein diet strategies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low protein diet with AC-134 | Dietary Supplement | Low protein diet combined with AC-134 Dosage: 2 capsules,three times/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated glomerular filtration rate (eGFR) measurement | The eGFR level is a maker for kidney function | Baseline to 3 months |
| Blood Urea Nitrogen (BUN) levels | Blood Urea Nitrogen | Baseline to 3 months |
| Uremic toxins assay | The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function | The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples | Baseline to 3 months |
| Inflammation makers | The concentration of inflammation makers in the subjects' blood samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng-Hsu Chen, MDPHD | Division of Nephrology in Taichung Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital. | Taichung | ROC | 40705 | Taiwan | ||
| Taichung Veterans General Hospital |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Standard treatment | Other | Low protein diet |
|
| Baseline to 3 months |
| Nutrition status | The concentration of albumin, wbc and uric acid in the subjects' blood samples | Baseline to 3 months |
| Lipid analysis | The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples | Baseline to 3 months |
| Sugar test | The concentration of fasting sugar and HbA1C in the subjects' blood samples | Baseline to 3 months |
| The quality of life | It will measure by the Kidney Disease Quality of Life ([KDQOL]-SF™) questionnaire | Baseline to 3 months |
| Anemia test | The concentration of hemoglobin (Hb) in the subject's blood samples | Baseline to 3 months |
| Urine protein analysis | Urine specimen collection will be evaluated on the spot and 24-hour urine protein | Baseline to 3 months |
| 24-hour Dietary recall | There will be collected by food models or a photography atlas to estimate portion size | Baseline to 3 months |
| Gastrointestinal symptoms measures | There will be collected by questionnaires symptoms or chief complaints | Baseline to 3 months |
| Grip strength levels | Hand grip strength was measured by grip strength device | Baseline to 3 months |
| Blood gas | The concentration of blood gas test in the subject's blood samples | Baseline to 3 months |
| Electrolytes Analysis | The concentration of electrolytes analysis in the subject's blood samples | Baseline to 3 months |
| Mitochondrial oxidative stress | The concentration analysis in the subject's blood or urine samples, such as MDA | Baseline to 3 months |
| Taichung |
| ROC |
| 40705 |
| Taiwan |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |