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

NCT01228006 | Unknown Phase 3

• 2 other identifiers: NATEMS0310Version 02 - March 11, 2010
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stress; Fatigue

Keywords

Reduction of stress and fatigue

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Improvement in quality of sexual function.

  14 and 28 days

• Improvement in quality of life.

  14 and 28 days.

• Decrease stress during treatment (28 days)

  14 and 28 days

• Decrease fatigue during treatment (28 days)

  14 and 28 days

Study Arms (2)

Treatment

EXPERIMENTAL

NatusGerin

Dietary Supplement: NatusGerin

Control

PLACEBO COMPARATOR

Gelatin capsules identical to drug test

Other: Placebo capsules

Interventions

NatusGerin DIETARY_SUPPLEMENT

1 capsule, 2 times a day.

Treatment

Placebo capsules OTHER

1 capsule, 2 times a day

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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);

Sponsors & Collaborators

• Azidus Brasil: lead

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandre Frederico, Physician

CONTACT

55 19 38293822; alexandre@lalclinica.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: October 25, 2010
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 25, 2010

Record last verified: 2010-10