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

Primary Purpose

Stress, Fatigue

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NatusGerin
Placebo capsules
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Reduction of stress and fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treatment

    Control

    Arm Description

    NatusGerin

    Gelatin capsules identical to drug test

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Improvement in quality of sexual function.
    Improvement in quality of life.
    Decrease stress during treatment (28 days)
    Decrease fatigue during treatment (28 days)

    Full Information

    First Posted
    April 8, 2010
    Last Updated
    October 22, 2010
    Sponsor
    Azidus Brasil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01228006
    Brief Title
    Study for Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals (Natugerin®) in Improvement of Stress and Fatigue
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    December 2011 (Anticipated)
    Study Completion Date
    December 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Azidus Brasil

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Fatigue
    Keywords
    Reduction of stress and fatigue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    NatusGerin
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Gelatin capsules identical to drug test
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    NatusGerin
    Intervention Description
    1 capsule, 2 times a day.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo capsules
    Intervention Description
    1 capsule, 2 times a day
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Improvement in quality of sexual function.
    Time Frame
    14 and 28 days
    Title
    Improvement in quality of life.
    Time Frame
    14 and 28 days.
    Title
    Decrease stress during treatment (28 days)
    Time Frame
    14 and 28 days
    Title
    Decrease fatigue during treatment (28 days)
    Time Frame
    14 and 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandre Frederico, Physician
    Phone
    55 19 38293822
    Email
    alexandre@lalclinica.com.br

    12. IPD Sharing Statement

    Learn more about this trial

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

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