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

Stress Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01228006
• Other study ID #: NATEMS0310
• Secondary ID: Version 02 - Mar
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 8, 2010
• Last updated: October 22, 2010
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2010
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: Alexandre Frederico, Physician
• Phone: 55 19 38293822
• Email: alexandre[@]lalclinica.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Fatigue
• Stress

Intervention

Dietary Supplement:
• NatusGerin
1 capsule, 2 times a day.

Other:
• Placebo capsules
1 capsule, 2 times a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		14 and 28 days	No
Secondary	Improvement in quality of sexual function.		14 and 28 days	No
Secondary	Improvement in quality of life.		14 and 28 days.	No
Secondary	Decrease stress during treatment (28 days)		14 and 28 days	No
Secondary	Decrease fatigue during treatment (28 days)		14 and 28 days	No