A Prospective, Interventional, Multi-centric, Randomized, Double blind, Two-arm, parallel Group, Placebo Controlled Clinical Study to evaluate the Efficacy & Safety of BACOMINDÂ®, a standardized extract from Bacopa monnieri on the treatment of attention deficit and hyperactivity disorder (ADHD) in children and adolescents

atural Remedies Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

atural Remedies Pvt Ltd