Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals in Improvement of Stress and Fatigue
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|ClinicalTrials.gov Identifier: NCT01100632|
Recruitment Status : Suspended
First Posted : April 9, 2010
Last Update Posted : October 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Reduction of Stress and Fatigue||Dietary Supplement: Ginseng, vitamins, minerals Other: Placebo - Gelatin capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||December 2010|
Treatment with the combination of Panax ginseng, vitamins and minerals
Dietary Supplement: Ginseng, vitamins, minerals
2 capsules per day
Placebo Comparator: Placebo
Other: Placebo - Gelatin capsule
2 capsules per day
- Reduction of stress and fatigue [ Time Frame: 14 and 28 days ]
- 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.
- Quality of life and Sexual Function [ Time Frame: 14 and 28 days ]
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.