Phase IV study, randomized, placebo-controlled for the evaluation of efficacy and tolerability of arginine aspartate in patients with moderate to severe fatigue
Phase 4
Completed
- Conditions
- Moderate to severe fatigueOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12608000535370
- Lead Sponsor
- ikkho Zydus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients between 18 to 70 years old
Informed consent
Rate = or more than 4 in the Piper Scale
Exclusion Criteria
Pregnants
Depression
Organic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical evaluation measured by the Piper scale[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)]
- Secondary Outcome Measures
Name Time Method 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)[During all study - 81 days (baseline - 7 days, treatment period - 60 days and follow up period - 14 days)]