Back to resultsEffectiveness Evaluation of Panax Ginseng, Vitamins and Minerals in Improvement of Stress and Fatigue
Primary Purpose
Reduction of Stress and Fatigue
Status
Suspended
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ginseng, vitamins, minerals
Placebo - Gelatin capsule
Sponsored by
About this trial
This is an interventional treatment trial for Reduction of Stress and Fatigue
Eligibility Criteria
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 exclusion criteria of the study:
- 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 color therapy, 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 undergoing treatment 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 disease 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
Placebo
Arm Description
Treatment with the combination of Panax ginseng, vitamins and minerals
Placebo.
Outcomes
Primary Outcome Measures
Reduction of stress and fatigue
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.
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 Outcome Measures
Quality of life and Sexual Function
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01100632
Brief Title
Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals in Improvement of Stress and Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Suspended
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Azidus Brasil
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Treatment with the combination of Panax ginseng, vitamins and minerals
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginseng, vitamins, minerals
Intervention Description
2 capsules per day
Intervention Type
Other
Intervention Name(s)
Placebo - Gelatin capsule
Intervention Description
2 capsules per day
Primary Outcome Measure Information:
Title
Reduction of stress and fatigue
Description
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.
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.
Time Frame
14 and 28 days
Secondary Outcome Measure Information:
Title
Quality of life and Sexual Function
Description
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.
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;
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 exclusion criteria of the study:
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 color therapy, 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 undergoing treatment 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 disease 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.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals in Improvement of Stress and Fatigue
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