Reduction of Stress and FatiguePhase 3NCT01100632
Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals in Improvement of Stress and Fatigue
A Phase 3 study testing Ginseng, vitamins, minerals in people with Reduction of Stress and Fatigue, run by Azidus Brasil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction of Stress and Fatigue
- What is being tested?
- Ginseng, vitamins, minerals
- 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 2010to Dec 2010
- 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;
- 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).
Who cannot join
- Constitute exclusion criteria of the study:
- 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);
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- 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.
About this study
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
- Being tested
- Ginseng, vitamins, minerals, Placebo - Gelatin capsule
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginseng, vitamins, mineralsDietary supplement
2 capsules per day
Placebo - Gelatin capsuleOther
2 capsules per day
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the combination of Panax ginseng, vitamins and minerals Receives: Dietary Supplement: Ginseng, vitamins, minerals |
| Placebo | Placebo comparator | Placebo. Receives: Other: Placebo - Gelatin capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of stress and fatigue
- Stress: ISS Scale will be assessed by the scale - Inventory of Symptoms of Stress in the time selection / screening, 14 and 28 days ± 2 days of treatment.
- Fatigue: FSS Scale will be assessed by the scale - Fatigue Severity Scale Selection in The Times / Triage, 14 and 28 days ± 2 days of treatment.
Measured: 14 and 28 days
Secondary outcomes (1)
Quality of life and Sexual Function
- Quality of life: the quality of life of patients will be assessed using the Short Form 36 questionnaire (SF-36) during the period included 14 and 28 days ± 2 days of treatment.
- Sexual function: evaluation of possible changes in libido or sexual performance that this drug will develop will be made by direct questioning by the doctor to the patient inclusion period 14 and 28 days ± 2 days of treatment.
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 posted9 Apr 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Stress and FatigueStudies 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
- NCT01100632
- Sponsor's protocol ID
- GEREMS0310
- Other IDs
- Version 01 - March 11, 2010
- Status last verified
- Apr 2010
- First submitted
- 7 Apr 2010
- Last updated
- 27 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals in Improvement of Stress and Fatigue
- ClinicalTrials.gov ID
- NCT01100632
- Acronym / sponsor ID
- GEREMS0310
- Conditions
- Reduction of Stress and Fatigue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 9 Apr 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.
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).
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: Ginseng, vitamins, mineralsTreatment with the combination of Panax ginseng, vitamins and minerals |
| Placebo | Placebo comparator | Other: Placebo - Gelatin capsulePlacebo. |
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;
- 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).
Key exclusion criteria (21 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 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);
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 |
|---|---|---|
| Ginseng, vitamins, minerals2 capsules per day | Dietary supplement | Treatment |
| Placebo - Gelatin capsule2 capsules per day | Other | Placebo |
Primary outcome
Reduction of stress and fatigue
Time frame: 14 and 28 days
1. Stress: ISS Scale will be assessed by the scale - Inventory of Symptoms of Stress in the time selection / screening, 14 and 28 days ± 2 days of treatment. 2. Fatigue: FSS Scale will be assessed by the scale - Fatigue Severity Scale Selection in The Times / Triage, 14 and 28 days ± 2 days of treatment.
1 secondary outcome
Quality of life and Sexual Function
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 27 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ginseng, vitamins, minerals in people with Reduction of 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 21 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: paused, as of the sponsor's last update on 27 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of stress and fatigue (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 27 Oct 2010.