Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals in Improvement of Stress and Fatigue

This study has suspended participant recruitment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01100632
First received: April 7, 2010
Last updated: October 26, 2010
Last verified: April 2010
  Purpose

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).


Condition Intervention Phase
Reduction of Stress and Fatigue
Dietary Supplement: Ginseng, vitamins, minerals
Other: Placebo - Gelatin capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Reduction of stress and fatigue [ Time Frame: 14 and 28 days ] [ Designated as safety issue: No ]
    1. 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.
    2. 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 [ Time Frame: 14 and 28 days ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment with the combination of Panax ginseng, vitamins and minerals
Dietary Supplement: Ginseng, vitamins, minerals
2 capsules per day
Placebo Comparator: Placebo
Placebo.
Other: Placebo - Gelatin capsule
2 capsules per day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01100632     History of Changes
Other Study ID Numbers: GEREMS0310, Version 01 - March 11, 2010
Study First Received: April 7, 2010
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014