Study for Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals (Natugerin®) in Improvement of Stress and Fatigue
NCT ID: NCT01228006
Last Updated: 2010-10-25
Study Results
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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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2011-09-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
NatusGerin
NatusGerin
1 capsule, 2 times a day.
Control
Gelatin capsules identical to drug test
Placebo capsules
1 capsule, 2 times a day
Interventions
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NatusGerin
1 capsule, 2 times a day.
Placebo capsules
1 capsule, 2 times a day
Eligibility Criteria
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Inclusion Criteria
* Patients older than 18 years, male or female, regardless of ethnicity or social class;
* Presence of pictures of mild to moderate stress, confirmed with the aid of the Stress Symptom Inventory (ISS), which considers stress and mild to moderate classification Alert classification Resistance;
* Presence frame of fatigue with a score greater than 36 according to the Fatigue Severity Scale (FSS).
Exclusion Criteria
* Current treatment with drugs that are stimulants or central nervous system depressants such as hypnotics, anxiolytics, antipsychotics, antidepressants, statins and muscle relaxants;
* Alternative Therapies that scientifically, or have no influence in the tables of stress or fatigue as acupuncture or relaxing massages;
* Treatment psychotherapeutic medication or not;
* Current treatment or prediction of treatment with oral anticoagulants (due to interaction with the tocopherol);
* Women who are pregnant or lactating;
* Patients with lactose intolerance;
* Patients allergic to soy or peanuts;
* chronic renal failure;
* Patients using other multivitamins or individual vitamins such as vitamin D and / or A.
* Chronic alcoholism;
* Patients with clinical diagnosis of diseases causing severe chronic pain or adversely affect the clinical interpretation as fibromyalgia, multiple sclerosis, neuropathies and myopathies;
* Patients with hypothyroidism or hyperthyreosis diagnosed clinically;
* Patient history and physical examination suggestive of severe hepatorenal failure;
* Patients with decompensated diabetes mellitus (fasting glucose above 180 mg / dL);
* Patients being treated for cancer;
* Amendment of the routine of life during the study as early vacation or suspected change in working hours;
* Patients with complaints of excessive sleepiness caused by organic source frameworks such as sleep apnea and morbid obesity (BMI above 35);
* History of hypersensitivity to any component of the product under investigation;
* Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
18 Years
ALL
No
Sponsors
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Azidus Brasil
INDUSTRY
Responsible Party
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LAL Clinica Pesquisa e Desenvolvimento Ltda
Central Contacts
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Other Identifiers
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Version 02 - March 11, 2010
Identifier Type: -
Identifier Source: secondary_id
NATEMS0310
Identifier Type: -
Identifier Source: org_study_id