A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study to Evaluate the Safety and Efficacy of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Improving Malnutrition in Patients With Cirrhosis
Overview
- Phase
- Not Applicable
- Intervention
- Oryz-Aspergillus Enzyme and Pancreatin Tablet
- Conditions
- Cirrhosis
- Sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.
- Enrollment
- 132
- Primary Endpoint
- 1. Change in nutritional status by Mid-Arm Muscle Circumference (MAMC) evaluation, the unit of MAMC is centimeter(cm).
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
* A total of 132 subjects with cirrhosis were divided into 3 subgroups by Child-Pugh score, which were Child-pugh Class A, B, and C, respectively. Each subgroup includes 44 subjects, which were randomly assigned to the Oryz-Aspergillus Enzyme and Pancreatin tablet group (treatment group) and the placebo group (control group) in a ratio of 3: 1 (33: 11). * Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the Oryz-Aspergillus Enzyme and Pancreatin tablet group or the placebo group. No matter which group the subjects is assigned, he/she would receive treatment drugs through oral administration for 180 days, during which the participant will not take any investigational drug. * The differences in nutritional status between treatment group and control group will be compared in 90 and 180 days by MAMC and SGA.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The age is range from 18 to 70 years old.
- •Sex is not limited.
- •Confirmed cirrhosis (pathologic or radiological rationale) with a mid-upper arm muscle circumference (MAMC) \< 90% of the standard value.
- •The subject or his family (guardians) agreed to participate in the study and signed the informed consent form.
- •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:
- •Pregnant, lactating women or women who do not exclude the possibility of pregnancy;
- •Total serum bilirubin ≥ 5 times the upper limit of normal;
- •Serum creatinine ≥ 1.2 times the upper limit of normal;
- •Prothrombin time ≥ 18 seconds;
- •Those who have an allergy to Oryz-Aspergillus Enzyme and Pancreatin Tablet and their related ingredients;
- •Subjects who are not able to eat orally for any reason;
- •Subjects with a history of previous intestinal obstruction;
- •Subjects with acute abdominal pain within 2 months prior to the start of the study;
- •Subjects with electrolyte (sodium, potassium, chlorine) disorders that cannot be corrected prior to the start of the study, if electrolyte (sodium, potassium, chlorine) disorders have occurred, have been corrected and stabilized for more than 1 month prior to the start of the study;
Arms & Interventions
Oryz-Aspergillus Enzyme and Pancreatin Tablet Arm
Oryz-Aspergillus Enzyme and Pancreatin Tablet ,2 tablets/time, 3 times daily. Study drug will be administered orally.
Intervention: Oryz-Aspergillus Enzyme and Pancreatin Tablet
Placebo Arm
Placebo,2 tablets/time, 3 timesdaily. Study drug will be administered orally.
Intervention: Placebo
Outcomes
Primary Outcomes
1. Change in nutritional status by Mid-Arm Muscle Circumference (MAMC) evaluation, the unit of MAMC is centimeter(cm).
Time Frame: 180 days
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
2. Change in nutritional status by Subjective Global Assessment (SGA) evaluation.
Time Frame: 180 days
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.