Black Seed Oil in ADHD

Sponsor
Ain Shams University
Study ID
NCT06542887
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Atomoxetine — DRUG
    Participants will continue receiving their treatment with atomoxetine at a dose of 0.5-1.4 mg/kg/day
  • Black Seed Oil Cap/Tab — DRUG
    Participants will receive black seed oil in the form of soft gelatin capsule 450 mg at a dose of 40-80 mg/kg/day given in one to two divided doses after meals for 12 weeks.

Study Details

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.

Key Dates

First listed
Aug 7, 2024
Start date
Oct 1, 2024
Status verified
Jul 2024
Primary completion
Oct 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Black Seed Oil Group
  • Active Comparator: Controlled Group

Primary Outcome Measure

Serum Glutathione Perioxidase [ Time Frame: 3 months ]

Central Contacts

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