Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a hybrid, two-arm, triple-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of the Stasis supplement on reducing oxidative stress, cortisol levels, and side effects associated with stimulant medications used for ADHD over a three-month period in adults.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stasis Supplement | Experimental |
| |
| Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stasis Daytime and Nighttime | Dietary Supplement | Daytime taken with stimulant medication and food. Nighttime taken 30 minutes before bedtime on an empty stomach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdG | Measurement of oxidative stress and cortisol levels will be assessed using the following validated biomarkers: hs-CRP and serum cortisol from blood samples 8-hydroxy-2'-deoxyguanosine (8-OHdG) from urine samples | Baseline and Month 3 |
| Change in cortisol levels | Serum cortisol concentration measured via blood draw. | Baseline and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep quality | Sleep quality assessed via self-report questionnaire. | Baseline, Month 1, Month 2, and Month 3 |
| Change in irritability | Irritability assessed via self-report questionnaire. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Renner, MSc | Contact | 4242450284 | hello@citruslabs.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Recruiting | Las Vegas | Nevada | 89118 | United States |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D020447 | Parasomnias |
| D005222 | Mental Fatigue |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Triple (Participant, Care Provider, Outcomes Assessor)
| Placebo | Dietary Supplement | Matched placebo product in taste and appearance. |
|
| Baseline, Month 1, Month 2, and Month 3 |
| Change in focus | Focus assessed via self-report questionnaire. | Baseline, Month 1, Month 2, and Month 3 |
| Change in sociability | Sociability assessed via self-report questionnaire. | Baseline, Month 1, Month 2, and Month 3 |
| Change in self-reported mood | Mood assessed via self-report questionnaire. | Baseline, Month 1, Month 2, and Month 3 |
| Change in self-reported stress | Stress levels assessed via self-report questionnaire. | Baseline, Month 1, Month 2, and Month 3 |
| Change in self-reported appetite | Appetite assessed via self-report questionnaire. | Baseline, Month 1, Month 2, and Month 3 |
| Change in blood levels of Vitamin C | Serum levels of Vitamin C measured via blood test. | Baseline and Month 3 |
| Change in blood levels of CoQ10 | Serum levels of Coenzyme Q10 measured via blood test. | Baseline and Month 3 |
| D009422 | Nervous System Diseases |
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |