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The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 2 groups, including Oryz-Aspergillus Enzyme and Pancreatin tablet group (treatment group) and the placebo group (control group). Treatment group includes 99 subjects, while control group includes 33 subjects. They receive investigational drug 2 tablets/times, tid, p.o. for 180 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oryz-Aspergillus Enzyme and Pancreatin Tablet Arm | Active Comparator | Oryz-Aspergillus Enzyme and Pancreatin Tablet ,2 tablets/time, 3 times daily. Study drug will be administered orally. |
|
| Placebo Arm | Placebo Comparator | Placebo,2 tablets/time, 3 timesdaily. Study drug will be administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oryz-Aspergillus Enzyme and Pancreatin Tablet | Drug | 2 tablets/time, 3 times daily,Oral Administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Change in nutritional status by Mid-Arm Muscle Circumference (MAMC) evaluation, the unit of MAMC is centimeter(cm). | The change in nutritional status of subjects at 180 days was evaluated by MAMC. MAMC, as a marker of lean muscle mass, is calculated using the standard formula: MAMC = MAC-(3.14 x TSF thickness). MAC: mid-arm circumference TSF : triceps skinfold thickness | 180 days |
| 2. Change in nutritional status by Subjective Global Assessment (SGA) evaluation. | The change in nutritional status of subjects at 180 days was evaluated by SGA Form. The nutritional status of the subjects was improved if any of the index reached the "effective" standard. | 180 days |
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Inclusion Criteria:
Note: MAMC formula: mid-arm muscle circumference (cm) = mid-arm circumference (cm) - 3.14 × triceps skinfoldthickness. Standard values: 25.3 cm for adult males and 23.2 cm for adult females.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010194 | Pancreatin |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
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| Placebo | Drug | 2 tablets/time, 3 times daily,Oral Administration. |
|
|
| D014020 |
| Tissue Extracts |
| D045424 | Complex Mixtures |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |