Reduction of Stress and Fatigue
Conditions
Brief summary
We hope that with the drug, patients obtain reduced levels of stress and fatigue, according to the scales that we use in the study. Hopefully the results of the treated group are significantly higher than the control group (placebo).
Interventions
DIETARY_SUPPLEMENTGinseng, vitamins, minerals
2 capsules per day
OTHERPlacebo - Gelatin capsule
2 capsules per day
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Agree with all study procedures, signing the IC in two ways; * Patients older than 18 years, male or female, regardless of ethnicity or social class; * Presence of mild to moderate stress, confirmed with the Stress Symptom Inventory (ISS); * Presence of staff fatigue with a score greater than 36 according to the Fatigue Severity Scale (FSS).
Exclusion criteria
Constitute
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of stress and fatigue | 14 and 28 days | 1. Stress: ISS Scale will be assessed by the scale - Inventory of Symptoms of Stress in the time selection / screening, 14 and 28 days ± 2 days of treatment. 2. Fatigue: FSS Scale will be assessed by the scale - Fatigue Severity Scale Selection in The Times / Triage, 14 and 28 days ± 2 days of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and Sexual Function | 14 and 28 days | c) Quality of life: the quality of life of patients will be assessed using the Short Form 36 questionnaire (SF-36) during the period included 14 and 28 days ± 2 days of treatment. d) Sexual function: evaluation of possible changes in libido or sexual performance that this drug will develop will be made by direct questioning by the doctor to the patient inclusion period 14 and 28 days ± 2 days of treatment. |
Outcome results
None listed