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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01228006
First received: April 8, 2010
Last updated: October 22, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Stress
Fatigue
Dietary Supplement: NatusGerin
Other: Placebo capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality of sexual function. [ Time Frame: 14 and 28 days ] [ Designated as safety issue: No ]
  • Improvement in quality of life. [ Time Frame: 14 and 28 days. ] [ Designated as safety issue: No ]
  • Decrease stress during treatment (28 days) [ Time Frame: 14 and 28 days ] [ Designated as safety issue: No ]
  • Decrease fatigue during treatment (28 days) [ Time Frame: 14 and 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
NatusGerin
Dietary Supplement: NatusGerin
1 capsule, 2 times a day.
Placebo Comparator: Control
Gelatin capsules identical to drug test
Other: Placebo capsules
1 capsule, 2 times a 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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228006

Contacts
Contact: Alexandre Frederico, Physician 55 19 38293822 alexandre@lalclinica.com.br

Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01228006     History of Changes
Other Study ID Numbers: NATEMS0310, Version 02 - March 11, 2010
Study First Received: April 8, 2010
Last Updated: October 22, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Reduction of stress and fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014