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