THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL

NCT ID: NCT06004375

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-05-30

Brief Summary

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The goal of this clinical trial is to determine effect of arginine and glutamine on outcome of COVID-19 patients. The main questions it aims to answer are:

-to test the effect of oral nutritional supplements containing arginine and glutamine on covid-19 patients outcome Dr. M. Djamil General Hospital Padang

Participants will given ONS containing arginine and glutamine. Researchers will compare intervention group with control group to see if ONS affected outcome of COVID-19 patients

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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intervention group

The intervention group was given a High-Calorie High-Protein + ONS diet containing 4.8 g arginine and 2 g glutamine, namely Neomune 2x 200 cc, purchased from Otsuka Pharmaceutical Co., Ltd

Group Type EXPERIMENTAL

Neomune

Intervention Type DIETARY_SUPPLEMENT

Neomune containing 4.8 g arginine and 2 g glutamine

control group

the control was administered with a High-Calorie High-Protein diet + ONS hospital standard.

Group Type ACTIVE_COMPARATOR

Neomune

Intervention Type DIETARY_SUPPLEMENT

Neomune containing 4.8 g arginine and 2 g glutamine

Interventions

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Neomune

Neomune containing 4.8 g arginine and 2 g glutamine

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients confirmed positive for COVID-19
* Age over 17 years
* The patient can take food orally

Exclusion Criteria

* Patients with restricted fluid intake
* Patients who cannot take food orally
* suffering from diabetes mellitus and kidney failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M. Djamil General Hospital

UNKNOWN

Sponsor Role collaborator

Universitas Sriwijaya

OTHER

Sponsor Role lead

Responsible Party

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Sari Bema Ramdika

Ms

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. M. Djamil General Hospital

Padang, West Sumatera, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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ID

Identifier Type: -

Identifier Source: org_study_id

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