Health Condition 1: - Health Condition 2: null- Attention deficit & hyperactivity disorder (ADHD) in children and adolescents, a mental disorder of the neurodevelopmental Type
Conditions
Interventions
Intervention1: BacoMind®- a standardized dried extract from Bacopa monnieri: Single oral dose, One Capsule a day in the morning after breakfast for 180 days
Control Intervention1: placebo without act
Sponsors
Natural Remedies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children/adolescents of both sexes between 6 and 16 years-old who exhibit mild to moderate ADHD, with predominantly inattentive or combined presentation, according to DSM-V criteria 2. Voluntary agreement to participate in the study 3. Informed Consent Form signed by legal guardians/research participant, when possible. 4. Results of laboratory tests (bio chemistry, blood count and urine), physical examination and vital parameters with no clinically significant changes (clinically significant changes are defined as laboratory results requiring acute drug intervention, indicating severe illness or requiring further medical evaluation according to the discretion of the investigator) 5. Subjects who have not participated in a similar investigation in the past four weeks 6. Subject is willing and able to comply with all trial requirements
Exclusion criteria
Exclusion criteria: 1. Legal guardians for the child andresearch participants who expressed a desire to not participate in this study 2. Research participants with hypersensitivity to the study drug 3. History of alcohol or drug abuse by the research participant 4. Primary psychiatric diagnoses other than ADHD using MINI-KID questionnaire 5. Diagnosis of psychiatric comorbidities, except for simple phobias, adjustment disorder, motor disorder, learning disorder, oppositional defiant disorder and sleep disorder 6. Personal history of seizures (except for mild febrile seizures) 7. Diagnosis of Tourette Syndrome and chronic tics 8. Research participants who are making use of drugs for the treatment of ADHD 9. Children/adolescents with ADHD predominantly hyperactive/impulsive 10. Research participants who are making use of anticonvulsants, antidepressants and antipsychotics up to 1 week prior to study entry or during the same 11. Other conditions considered by the investigator as reasonable for disqualification of the subjectâ??s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in ADHD symptoms from baseline to 6 months as measured by the SNAP-IV 2. Changes in CGI-I Scale scores from baseline to 6 months Timepoint: From Baseline to End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in computer-based Continuous Performance Test from baseline to 6 months 2. Rey Auditory Verbal Learning Test scores Safety: Blood pressure ), temperature, pulse rate, respiratory rate, physical examination, serum complete blood picture, biochemistry (blood glucose, total protein, albumin, transaminases AST and ALT, ALP, creatine kinase (CK), creatinine, urea, uric acid, total bilirubin. Timepoint: From Baseline to End of Treatment | — |
Countries
India
Contacts
Public ContactDr Harisha s
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed