Health Condition 1: F902- Attention-deficit hyperactivity disorder, combined type Health Condition 2: F901- Attention-deficit hyperactivity disorder, predominantly hyperactive type Health Condition 3: F900- Attention-deficit hyperactivity disorder, predominantly inattentive type
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female children aged ages = 5 years and =12 years 2.Patients diagnosed with mild form of ADHD according to DSM IV criteria including clinician interview. 3.Primary caregiver (parent or guardian) of patients who can and willing to provide written Informed Consent and child participant gives assent. 4.Patients and their parents willing to follow the procedures as per the study protocol. 5.Patients who agree to take investigational product till Day 56. 6.Patients who are able to swallow study medication. 7.Patients having capability of complete compliance and completion of follow-up . 8.Patient/ patient’s caretaker (parent/ guardian) understands and can comply with clinical trial protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Patients ? 5 years or ? 12 years of age. 2.Patients who are on any stimulant or non-stimulant pharmacotherapy for ADHD prior to study start/ screening. 3.Patients diagnosed with additional mental health disorder [Obsessive-Compulsive Disorder (OCD), major depressive disorders, mood disorder]. 4.Patients diagnosed with cancer. 5.Patients having a history or presence of any medical conditions which impacts the quality of life. 6.Patients with hypersensitivity to the study product or placebo. 7.Patients currently using vitamin or mineral supplements, nutritional supplements and or medical foods within 30 days before the commencement of study or during the study. 8.Patients using prescription medications and/or non-prescription medications for acute medical conditions, semi-acute medical conditions, and weight loss. 9.Patients who are not willing to take investigational product/ patients’ care takers (parent/ guardian) who are not willing for their child to take investigational product. 10.Patients with uncontrolled, unstable comorbidities. 11.Patients taking part in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements. 12.Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled, unstable comorbidities. 13.Patients who had participated in other clinical trials during previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ADHD Rating Scale IV - clinician administered through interview with parents, score from baseline to end of studyTimepoint: Baseline and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of PROMIS- Sleep, Anxiety, Quality of Life-Parent VersionTimepoint: Baseline and Day 56;Behaviour Rating Inventory of Executive Function 2 (BRIEF-2)Timepoint: Baseline and Day 56;Clinician Global Impression Scale (7 point Likert Scale)Timepoint: Baseline and Day 56;Frequency of adverse events between groupsTimepoint: Baseline and Day 56;Severity of adverse events between groupsTimepoint: Baseline and Day 56 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed