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Trial registered on ANZCTR
Registration number
ACTRN12608000535370
Ethics application status
Approved
Date submitted
24/09/2008
Date registered
22/10/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Phase IV study, randomized, placebo-controlled for the evaluation of efficacy and tolerability of arginine aspartate in patients with moderate to severe fatigue
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Scientific title
Phase IV study, randomized, placebo-controlled for the evaluation of efficacy and tolerability of arginine aspartate in patients with moderate to severe fatigue
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Secondary ID [1]
252340
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Not aplicable
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Moderate to severe fatigue
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Condition category
Condition code
Other
3913
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arginine aspartate 250mg administration orally during 60 days, 2 tablets twice a day (after breakfeast and after dinner)
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Intervention code [1]
3452
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Treatment: Drugs
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Comparator / control treatment
Placebo (the same substances except for arginine aspartate) administration orally during 60 days, 2 tablets twice a day (after breakfeast and after dinner)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Clinical evaluation measured by the Piper scale
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Assessment method [1]
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Timepoint [1]
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Evaluation will be measured in screening - visit 1 (7 days before baseline), baseline - visit 2 (day = 0), visit 3 (day =30), visit 4 (day = 60 - end of treatment period)
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Secondary outcome [1]
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Tolerability measured by patient adverse event reports (Serious and non serious adverse event). Arginine aspartate rarely presents alergic reactions or other adverse event, however every single adverse event presented during the study (81 days - screening, treatment period and follow up period) will be followed. The adverse events will be assessed by patient reports during each study visit and/or patient contact at any time. Non serious adverse events will be recorded at the Case Report Form (CRF) and serious adverse events will be recorded at a special serious adverse event report form (e.g. Council for International Organizations of Medical Sciences (CIOMS)
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Assessment method [1]
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Timepoint [1]
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During all study - 81 days (baseline - 7 days, treatment period - 60 days and follow up period - 14 days)
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Eligibility
Key inclusion criteria
Patients between 18 to 70 years old
Informed consent
Rate = or more than 4 in the Piper Scale
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Pregnants
Depression
Organic disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/01/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Nikkho Zydus
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Address [1]
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Rua Jaime Perdigao, 431- Rio de Janeiro
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Country [1]
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Brazil
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Primary sponsor type
Commercial sector/Industry
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Name
Nikkho Zydus
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Address
Rua Jaime Perdigão 431- Rio de Janeiro
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Country
Brazil
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Federal University of Sao Paulo
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Ethics committee address [1]
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Ethics committee country [1]
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Brazil
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Date submitted for ethics approval [1]
5980
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Approval date [1]
5980
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Ethics approval number [1]
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Summary
Brief summary
Fatigue is a very frequent symptom and is present in 50% of patients that seek a doctor’s appointment.
Fatigue could be defined as an oppressive feeling, sustained by exhaustion and reduced capacity of physical and mental works on the habitual level. Its defining characteristics include signs and symptoms that are linked to the control of body energy, to difficulty in doing daily normal activities, to verbalization of extreme exhaustion, and contribute to generation and establishment of lack of concentration, lack of interest, reduced libido and a feeling of guilt for not playing expected social roles.
The L-arginin is a precursor in the synthesis of Nitric Oxide (NO). This Oxide is a molecule that plays different roles in the body. Among them is the stimulation of the immunological response mediated by lymphocytes and macrophages; the reduction of the blood platelet hiperaggregation and the maintenance of vascular tonus in the regulation of arterial pressure, that involves the dynamic equilibrium between NO and endothelins.
The L-arginin is a semi-essential aminoacid produced by the body, although it is not an enough production for all what is needed for.
The arginin aspartate can also decrease fatigue and acts in several types of asthenia, strengthening the muscular capacity and having a support role in the treatment of various processes including the ones caused by stress.
In prolonged administration of arginin, there is an increase in the production of Nitric Oxide, and its supplementation has been related to an improvement of the contractile function of the skeletal muscle. The hypothesis that this improvement in muscular strength occurs in the short term has been related to the vasodilator effect of the NO with consequent improvement of muscular perfusion.
If we take into consideration that fatigue is a sufficiently important symptom to compromise the quality of life, leading a person to feel limited in dealing with her daily chores since once she initiates her activities, she can feel tired prematurely; supplementation with arginin would increase the production of NO with improvement of muscular response to the daily life activities, this way, decreasing the intensity or even eliminating the symptom fatigue.
The objective of this study is to find fatigue descrease by Piper Scale. The classification of the Piper scale has to decrease after 60 days of treatment comparing to basal classification (before treatment).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Tatiana Ferian da Fonseca
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Address
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Rua Borges Lagoa 1080- conj.101
São Paulo
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Country
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Brazil
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Phone
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55.11.59044454
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Fax
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55.11.50837848
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Email
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[email protected]
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Contact person for scientific queries
Name
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Tatiana Ferian da Fonseca
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Address
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Rua Borges Lagoa, 1080- conj.101
São Paulo
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Country
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Brazil
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Phone
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55.11.59044454
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Fax
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55.11.50837848
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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