StressPhase 3NCT01228006
Study for Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals (Natugerin®) in Improvement of Stress and Fatigue
A Phase 3 study testing NatusGerin in people with Stress and Fatigue, run by Azidus Brasil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- NatusGerin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- NatusGerin, Placebo capsules
- Keywords
- Reduction of stress and fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatusGerinDietary supplement
1 capsule, 2 times a day.
Placebo capsulesOther
1 capsule, 2 times a day
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | NatusGerin Receives: Dietary Supplement: NatusGerin |
| Control | Placebo comparator | Gelatin capsules identical to drug test Receives: Other: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 and 28 days
Secondary outcomes (4)
Improvement in quality of sexual function.
Measured: 14 and 28 days
Improvement in quality of life.
Measured: 14 and 28 days.
Decrease stress during treatment (28 days)
Measured: 14 and 28 days
Decrease fatigue during treatment (28 days)
Measured: 14 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startSep 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228006
- Sponsor's protocol ID
- NATEMS0310
- Other IDs
- Version 02 - March 11, 2010
- Status last verified
- Oct 2010
- First submitted
- 8 Apr 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals (Natugerin®) in Improvement of Stress and Fatigue
- ClinicalTrials.gov ID
- NCT01228006
- Acronym / sponsor ID
- NATEMS0310
- Keywords
- Reduction of stress and fatigue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: NatusGerinNatusGerin |
| Control | Placebo comparator | Other: Placebo capsulesGelatin capsules identical to drug test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (20 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatusGerin1 capsule, 2 times a day. | Dietary supplement | Treatment |
| Placebo capsules1 capsule, 2 times a day | Other | Control |
Primary outcome
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
4 secondary outcomes
Improvement in quality of sexual function.
Time frame: 14 and 28 days
Improvement in quality of life.
Time frame: 14 and 28 days.
Decrease stress during treatment (28 days)
Time frame: 14 and 28 days
Decrease fatigue during treatment (28 days)
Time frame: 14 and 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NatusGerin in people with Stress and Fatigue, run by Azidus Brasil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Frederico, Physician (55 19 38293822, alexandre@lalclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2010.