A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition

NCT04057326 | Unknown DMC

• 1 other identifier: Combizym-PEM-001
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Drug: Oryz-Aspergillus Enzyme and Pancreatin Tablet

Placebo Arm

PLACEBO COMPARATOR

Placebo,2 tablets/time, 3 timesdaily. Study drug will be administered orally.

Drug: Placebo

Interventions

Oryz-Aspergillus Enzyme and Pancreatin Tablet DRUG

2 tablets/time, 3 times daily,Oral Administration.

Also known as: Treatment Group :Combizym

Oryz-Aspergillus Enzyme and Pancreatin Tablet Arm

Placebo DRUG

2 tablets/time, 3 times daily,Oral Administration.

Also known as: Control Group

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Subjects with prior hepatic encephalitic stage II or higher;
• History of refractory ascites with moderate or higher ascites within 2 weeks prior to the start of the study;
• Subjects with symptoms of gastrointestinal bleeding such as melena and hematemesis within 2 weeks prior to the start of the study;
• Those who have used antibiotics within 2 weeks prior to the start of the study;
• Subjects who experienced other conditions that could affect the study: Subjects who had acquired or primary, secondary immune system conditions (except primary autoimmune liver disease) such as major cardiopulmonary disease, diabetes mellitus, tumors, HIV infection, and other conditions that required long-term hormonal therapy;

Sponsors & Collaborators

• Shenzhen Kangzhe Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Fibrosis

Interventions

Pancreatin; Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 15, 2019
• Study Start: August 30, 2019
• Primary Completion: December 30, 2020
• Study Completion: March 28, 2021
• Last Updated: August 15, 2019

Record last verified: 2019-08