Study for Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals (Natugerin®) in Improvement of Stress and Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01228006
Recruitment Status : Unknown
Verified October 2010 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Information provided by:
Azidus Brasil

Brief Summary:
It is hoped that the group treated with Panax Ginseng, Vitamins and Minerals obtain significant reduction in levels of stress and fatigue and that the results are superior to the placebo group.

Condition or disease Intervention/treatment Phase
Stress Fatigue Dietary Supplement: NatusGerin Other: Placebo capsules Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Minerals
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment
Dietary Supplement: NatusGerin
1 capsule, 2 times a day.
Placebo Comparator: Control
Gelatin capsules identical to drug test
Other: Placebo capsules
1 capsule, 2 times a day

Primary Outcome Measures :
  1. To evaluate the efficacy of the product Natus Gerin, compared to placebo, ® in improving symptoms of stress and fatigue in patients with clinical diagnosis of mild to moderate stress [ Time Frame: 14 and 28 days ]

Secondary Outcome Measures :
  1. Improvement in quality of sexual function. [ Time Frame: 14 and 28 days ]
  2. Improvement in quality of life. [ Time Frame: 14 and 28 days. ]
  3. Decrease stress during treatment (28 days) [ Time Frame: 14 and 28 days ]
  4. Decrease fatigue during treatment (28 days) [ Time Frame: 14 and 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Agree with all study procedures, signing the IC in two ways, by his own free will;
  • 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:

  • Participation in clinical trials in the 12 months preceding the survey;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01228006

Contact: Alexandre Frederico, Physician 55 19 38293822

Sponsors and Collaborators
Azidus Brasil

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda Identifier: NCT01228006     History of Changes
Other Study ID Numbers: NATEMS0310
Version 02 - March 11, 2010
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010

Keywords provided by Azidus Brasil:
Reduction of stress and fatigue

Additional relevant MeSH terms:
Signs and Symptoms