CLINICAL TRIAL

Treatment for Fatigue

Recruiting · 18+ · All Sexes · Fort Lauderdale, FL

Evaluate the Effectiveness and Safety of the Alpinia Galanga Formulation, Theacrine Formulation, and Caffeine Formulation on Fatigue, Mental Acuity, and Cognitive Health.

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About the trial for Fatigue

Eligible Conditions
Fatigue · Mental Fatigue

Treatment Groups

This trial involves 4 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Alpinia galanga formulation
DIETARYSUPPLEMENT
Control Group 2
Theacrine formulation
DIETARYSUPPLEMENT
Control Group 3
Caffeine formulation
DIETARYSUPPLEMENT
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I get tired sometimes and would like more energy. show original
Can use a smartphone, tablet, or computer that has enough memory to add more applications and has reliable internet service. show original
, Cohen has not needed to restrict her diet in any way Even though she is generally healthy and has no significant digestion or absorption issues, Cohen has not needed to restrict her diet in any way. show original
and internet connection You can take tests online with a computer and internet connection. show original
Employed in a job that has daytime work hours or shifts, if employed show original
with 95% accuracy Can confidently and accurately complete an Activity Log and Study Product Log daily. show original
, fever and productive cough A person who is 30-70 years old, male or female, who has a fever and a productive cough can be said to have ambulatory pneumonia. show original
A body mass index (BMI) of 18.5 - 34.9
Has consumed no more than two cups of coffee or caffeinated beverage per day for seven or more days before Screening/baseline
Can print out and return documents by scanning them, emailing them, or mailing them. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 14 Days
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 Days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 14 Days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome, 1 secondary outcome, and 2 other outcomes in patients with Fatigue. Measurement will happen over the course of 14 Days.

LSEQ (Leeds Sleep Evaluation Questionnaires)
14 DAYS
Assessment of the mean change in the results of the LSEQ survey from baseline
14 DAYS
VAS-F (Visual Analogue Scale to Evaluate Fatigue Severity)
14 DAYS
Assessment of the mean change in the results of the VAS-F survey from baseline
14 DAYS
SF-36 Health Survey (Short Form 36)
14 DAYS
Assessment of the mean change in the results of the SF-36 Health survey from baseline
14 DAYS
BCAT-SF (Brief Cognitive Health Assessment Short Form)
14 DAYS
Assessment of the mean change in the results of the BCAT-SF survey from baseline
14 DAYS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of treatment?

There is a wide range of common side effects of therapy. These side effects have to be considered in counseling patients who opt for treatment and in the planning of future randomized trials.

Anonymous Patient Answer

What is the latest research for fatigue?

The main issue concerning the treatment of fatigue is addressing the complex, multifaceted etiology of fatigue. In order to obtain effective treatments, it is critical to understand the neurobiological mechanisms underlying the development of fatigue.

Anonymous Patient Answer

What are common treatments for fatigue?

This article discusses the current treatments for fatigue including pharmacological and non-pharmacological interventions for reducing the symptom of this debilitating condition. Many interventions have been described, in the literature, such as cognitive behavioural therapy, relaxation, exercise, and medications like the benzodiazepines, antidepressants such as the selective serotonin reuptake inhibitors, and anticonvulsants. Of these, cognitive behavior therapies and selective serotonin reuptake inhibitors are frequently recommended. In the management of fatigue, the clinician should always consider patient preference and their capacity to participate in the therapeutic process.

Anonymous Patient Answer

What is fatigue?

There are many different ways to experience fatigue, but to summarize each aspect of the experience, you have to acknowledge the underlying process. The two general aspects of fatigue experience are the subjective experience in which the mood of the person is affected and the objective experience of reduced efficiency or loss of function which arises from physiological factors. The subjective way tiredness is perceived by an individual can take the form of the sensation of not getting enough sleep, a feeling as if one is just "not up to it" or a general tiredness that goes from one moment to the next. But the objective way tiredness is measured as a loss of energy, not so much a lack of capacity or function as some type of power deficit.

Anonymous Patient Answer

What are the signs of fatigue?

As the fatigue and fatigue severity score (FAS) provides a rating of a subject's subjective fatigue, the correlation between subjective and objective measure and fatigue can be assessed. Subjective fatigue is measured by self-administered scales (such as the FAS, or the fatigue symptom checklist or other measures). Objective measure by measures to assess physical tiredness or exhaustion level. A summary of these measures showing a clear correlation between subjective and objective scores should alert the physician to suspicion of persistent fatigue syndrome. The FAS scale is reliable, with high internal consistency for measurement properties across research studies.

Anonymous Patient Answer

How many people get fatigue a year in the United States?

[Between 1 in 6 and 1 in 11 Americans were surveyed in 2005-2006 and reported to have at least one day a year [through fatigue]] (https://www.cdc.gov/measur/fatigue2.html).

Anonymous Patient Answer

What causes fatigue?

Fatigue is a complex disorder that can affect both physical and mental faculties, and the autonomic nervous system and hypothalamic-pituitary-adrenal axis also play an important role. A systematic approach, which aims to identify and understand specific symptom clusters and to find effective treatments, will be required for the management of fatigue.

Anonymous Patient Answer

Who should consider clinical trials for fatigue?

Patient characteristics that are often identified in clinical research evaluations for fatigue as a primary or secondary end point are not related to baseline fatigue level, quality of life, or depression. Because these characteristics do not appear to influence fatigue levels, fatigue appears to be a less useful endpoint versus fatigue-specific QOL or function measurements in clinical trials. Future studies should address the impact of fatigue on quality of life.

Anonymous Patient Answer

Is treatment safe for people?

Both patient and carer satisfaction were high. Overall, there are significant improvements in the management of pain, with a reduced number of side effects, and a decreased number of hospitalisations.

Anonymous Patient Answer

Have there been any new discoveries for treating fatigue?

As of 2015, multiple factors contribute to fatigue: psychological, physical, and cognitive. Physical fatigue has physical and psychological components. Psychosocial fatigue is a condition of the subjective experience of fatigue, and can be treated through a variety of physical, psychological, and educational therapies. There is some preliminary evidence for fatigue management and treatment with serotonin modulating compounds to improve fatigue. However, because these approaches are still in the early stages of testing, the full potential of these therapies for treating fatigue is not yet clear.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

A wide breadth of treatment modalities is used in combination. Some treatments were commonly combined in all treatments, while others were often used by only a small portion of patients. For example, behavioral techniques were used in most CBT and motivational group programs, but rarely in individualized treatments.

Anonymous Patient Answer
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