CClinicalTrials.gg
Status unknownNCT01228006Updated Oct 25, 2010

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

A Phase 3 interventional study of NatusGerin and Placebo capsules in Stress and Fatigue, sponsored by Azidus Brasil. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-25.

Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stress
  • Fatigue

Browse trials for

Keywords

  • Reduction of stress and fatigue
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 300 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Treatment

    NatusGerin

    Dietary Supplement: NatusGerin

  • Placebo comparator
    Control

    Gelatin capsules identical to drug test

    Other: Placebo capsules

Interventions

  • Dietary supplementNatusGerin

    1 capsule, 2 times a day.

  • OtherPlacebo capsules

    1 capsule, 2 times a day

06

What researchers measure

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

    Time frame: 14 and 28 days

Secondary outcomes

  1. Improvement in quality of sexual function.

    Time frame: 14 and 28 days

  2. Improvement in quality of life.

    Time frame: 14 and 28 days.

  3. Decrease stress during treatment (28 days)

    Time frame: 14 and 28 days

  4. Decrease fatigue during treatment (28 days)

    Time frame: 14 and 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01228006
Lead sponsor
Azidus Brasil
First posted
Oct 25, 2010
Start date
Sep 2011
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Oct 25, 2010

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion