NCT01228006

UnknownPhase 3

Study for Effectiveness Evaluation of Panax Ginseng, Vitamin...

Azidus Brasil Source

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Other study identifiers

Sponsor study identifier

NATEMS0310

Secondary identifiers

Version 02 - March 11, 2010

Study Type

interventional

Estimated enrollment

300

Locations

0 countries

Sites

N/A

Timeline

Study Start

September 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 300 participants
Study completion date: December 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 8, 2010
Actual (reported)
First Posted
October 25, 2010
Actual (reported)
Study Start
September 2011
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: October 25, 2010
Status Verified: October 2010
Last Update Submitted: October 22, 2010

Conditions

Fatigue Stress

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

NatusGerinDietary supplement

1 capsule, 2 times a day.

Treatment

Placebo capsulesOther

1 capsule, 2 times a day

Control

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Azidus Brasil
Industrylead

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological 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 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2011

Estimated (date passed)

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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);
+5 more criteria

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

October 25, 2010

Record last verified: 2010-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01228006
Data provider: ClinicalTrials.gov
Source updated: 2010-10-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:09 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Treatment

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record