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

NCT ID: NCT01100632

Last Updated: 2010-10-27

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-12-31

Brief Summary

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).

Conditions

Reduction of Stress and Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Treatment with the combination of Panax ginseng, vitamins and minerals

Group Type: EXPERIMENTAL

Ginseng, vitamins, minerals

Intervention Type: DIETARY_SUPPLEMENT

2 capsules per day

Placebo

Placebo.

Group Type: PLACEBO_COMPARATOR

Placebo - Gelatin capsule

Intervention Type: OTHER

2 capsules per day

Interventions

Ginseng, vitamins, minerals

2 capsules per day

Intervention Type: DIETARY_SUPPLEMENT

Placebo - Gelatin capsule

2 capsules per day

Intervention Type: OTHER

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clinica Pesquisa e Desenvolvimento Ltda

Other Identifiers

Version 01 - March 11, 2010

Identifier Type: -

Identifier Source: secondary_id

GEREMS0310

Identifier Type: -

Identifier Source: org_study_id