Health Condition 1: G968- Other specified disorders of central nervous system
Conditions
Interventions
Intervention1: Test Product: KSM 66 Ashwagandha Gummies (150 mg), twice a day for 8 weeks
Control Intervention1: Control Product: Placebo capsule (150 mg), twice a day identical to KSM 66 Ashwagandha
Sponsors
D Y Patil Medical College Hospital and Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Parent-reported concerns in child’s attention, concentration, or memory 2. Attendance to mainstream schooling and mainstream classing 3. Healthy males and females aged between 6 and 12 years 4. Parent/legal guardian and child willing to provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial. 5. Child willing and able to swallow capsules 6. BMI between 18 and 30 kg/m2 7. No plan to commence new treatments over the study period 8. Parents and children fluent in English
Exclusion criteria
Exclusion criteria: 1. Current or 12-month history in child of any psychiatric disorder (including ADHD) 2. Child is currently taking pharmaceutical medications expected to affect behavior and learning. 3. Current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes 4. Any diagnosed learning disorders 5. Currently taking nutraceutical supplements 6. Children who are experiencing exceptional social/family stressors (e.g., serious illness in the family, recent parental separation, etc). 7. Any significant surgeries over the last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Computerized Mental Performance Assessment System (COMPASS) Timepoint: screening week 0, and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavior Rating Inventory of Executive Function, 2 nd Ed (BRIEF2) (Parent version)Timepoint: screening week 0, week 4 and week 8;PROMIS Parent Proxy FatigueTimepoint: screening week 0, week 4 and week 8;Sleep Disturbance Scale for Children (SDSC)Timepoint: screening week 0, week 4 and week 8 ;Strengths and Difficulties Questionnaire (SDQ) – parent versionTimepoint: screening week 0, week 4 and week 8 | — |
Countries
Australia, India
Contacts
Public ContactDr Deepak Langade
D Y Patil Medical College, Hospital and Research Center
Outcome results
None listed