Black Seed Oil in ADHD
NCT Number: NCT06542887
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: ADHD
Interventions: DRUG: Atomoxetine|DRUG: Black Seed Oil Cap/Tab
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-10-01

Summary:
Attention-Deficit/Hyperactivity Disorder is one of the most prevalent neuropsychiatric disorders affecting children with known persistence into adulthood in about 60% of patients. The mainstay treatment for ADHD is the pharmacological treatment involving stimulants (methylphenidate, amphetamines) and non-stimulants (atomoxetine, guanfacine, clonidine). Although these options have been found to be effective, these agents may not always be promising, as a proportion of patients may not respond or may not be able to tolerate their adverse events. Thus, increasing studies are exploring alternative therapies for ADHD, focusing on the neuroprotective effects of dietary and natural compounds like antioxidants that can be serving as an alternative or supplement to classical treatment with fewer side effects. Oxidative stress and neuroinflammation have been extensively addressed in ADHD and several studies on antioxidants in pediatrics with ADHD have shown promising results in improving symptoms and reducing scores on ADHD questionnaires.

Black seed oil (BSO) has shown anti-inflammatory and antioxidant properties in several human studies. Also numerous in-vitro studies have shown that nigella sativa possesses neuroprotective effects that are attributed to its antioxidant and anti-inflammatory effects. Thymoquinone (TQ) possesses the majority of nigella sativa oil (NSO) therapeutic benefits with the ability to target the central nervous system owing to its low molecular weight and lipophilic nature. In rats, thymoquinone administration significantly improved cognition by enhancing cholinergic function, synaptic plasticity, and attenuating oxidative damage and neuroinflammation, as shown by increased SOD and TAC and reduced MDA, NO, TNF-α immunoreactivity, and AChE activities. Previous human studies suggested that nigella sativa can stabilize mood, reduce anxiety, and regulate cognition, attention, and memory. In a previous animal study on ADHD mice model, Nigella sativa oil showed a reduction in inattention and hyperactivity with lower glutamate levels, and also showed higher recognition memory, glutathione peroxidase levels, dopamine levels, and neuronal density compared to the ethanol group only.

Primary Outcome Measures: Serum Glutathione Perioxidase, Blood samples will be withdrawn from each patient at baseline and after 12 weeks. Samples will be centrifuged, and the sera will be separated and stored at -80°C till analysis. Serum GPx will be measured using human GPx ELISA kit at baseline and after 12 weeks., 3 months
Secondary Outcome Measures: NICHQ Vanderbilt Assessment Scale-PARENT Informant, The symptoms and severity of ADHD will be assessed using NICHQ Vanderbilt Assessment Scale-PARENT Informant for children aged 6-12 at baseline and after 12 weeks.

The initial assessment scale has a total of 55 items in two components: symptom assessment and impairment in performance. Symptom assessment screens for symptoms that meet criteria for both inattentive (1-9) and hyperactive (10-18) ADHD. Also screens for symptoms of three other co-morbidities: oppositional defiant (19-26), conduct (27-40), and anxiety/depression (41-47). A positive response in symptom screens is a 2 or 3 (often, very often).

The second section of the scale has a set of performance measures (48-55), scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.

To meet the DSM-5 criteria for ADHD diagnosis, one must score 2 or 3 on at least 6 out of either the inattentive 9 or hyperactive 9 core symptoms or both and score 4 or 5 on any of the performance questions., 3 months|Child Health Questionnaire Parent Form 28 item (CHQ-PF28), To assess the impact of ADHD on quality of life, Child Health Questionnaire Parent Form 28 item (CHQ-PF28) will be completed by parents at baseline and after 12 weeks.

The CHQ-PF28 measures the following scales: Physical Functioning (3 items), Role functioning: emotional/behavior (1 item), Role functioning: physical (1 item), Bodily Pain (1 item), General Behavior (4 items), Mental Health (3 items), Self Esteem (3 items), General Health (4 items), Change in Health (1 item), Parental Impact-Emotional (2 items), Parental Impact-Time (2 items), Family Activities (2 items), and Family Cohesion (1 item).

Response options vary from four to six levels for the scales. Per scale, the items are summed up and transformed into a scale from 0 (worst possible score) to 100 (best possible score), yielding two summary component scores of physical (PhS) and psychosocial (PsS) health., 3 months