Health Condition 1: F900- Attention-deficit hyperactivity disorder, predominantly inattentive type
Conditions
Interventions
Intervention1: Cognitus/Bacomind: Bacopa monnieri (Brahmi) is a plant traditionally used in Ayurvedic medicine to treat anxiety and memory impairment. Considering that Bacopa monnieri shows positive e
Sponsors
Natural Remedies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children/ adolescent of both sexes between 6 years to 16 years old who exhibit mild to moderate ADHD with predominantly inattentive or combined presentation according to DSM V criteria. 2.Inattentive subset and hyperactivity subset of not greater than 23 on SNAP IV scale. 3. Voluntary assent to participate in the study from all whose are more then 7 years of age. 4. Informed Consent signed by legal guardian/research participant when possible. 5. Results of lab tests(chemistry, blood count and urine), physical examination and vital parameters with no clinically significant changes.
Exclusion criteria
Exclusion criteria: 1. WISC-IV-SF, subjects whose score are less than 80. 2.Research participants with known hypersensitivity to the other medication. History of alcohol or drug abuse by research participant. 3. Where the immediate concern is around another primary psychiatric diagnosis other than ADHD. 4. Diagnosis of psychiatric comorbidities, except for simple phobia, adjustment disorders, learning disorders, oppositional defiant disorder and sleep disorders. 5. History of seizures(except for mild febrile seizures) within 2 years from the time of recruitment. 6. Diagnosis of Tourette Syndrome and chronic tics. 7. Research participants who are making use of drugs for the treatment of ADHD in last three months. 8. Research participants who are making use of anticonvulsants, antidepressants and anti psychotics upto 6 weeks prior to study entry. 9. Positive beta HCG test for girls who have attained menarchy. 10. Patient at identified risk of suicide through clinical interview. 11. Children/ adolescents with ADHD predominantly hyperactive/impulsive. 12. Other conditions considered by the investigator as reasonable for the disqualification of the subject,s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD symptoms as measured by the SNAP-IV and CGI-I Scale scores.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Computer-based Continuous Performance Test scores and Rey Auditory Verbal Learning Test (RAVLT) scores. 2. SafetyTimepoint: 1. on week 0, 14 and 28 2. on week 0 and 28 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Natural Remedies Pvt. Ltd.
Outcome results
None listed