Effects of a standardized extract from Bacopa monnieri on the treatment of attention deficit & hyperactivity disorder in children and adolescents (ADHD)

atural Remedies Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•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.

•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.

发起方

atural Remedies Private Limited