Effect of Bacopa monnieri on ADHD in children and adolescents.
- Conditions
- Health Condition 1: F908- Attention-deficit hyperactivity disorder, other typeHealth Condition 2: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
- Registration Number
- CTRI/2023/08/056451
- Lead Sponsor
- atural Remedies Pvt. Lt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Children adolescents of both sexes between 6 and 16 years old (both inclusive), who exhibit mild to moderate ADHD, with predominantly inattentive or combined presentation, according to DSM V criteria (assessed via the MINI KID).
2.Inattentive subset and hyperactivity subset of not greater than 22 on SNAP IV scale.
3.Voluntary Assent to participate in the study from all those who are more than 7 years of age.
4.Informed Consent Form signed by legal guardians.
5.Results of laboratory tests (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)
1.Wechsler Intelligence Scale for Children Fourth Edition Short Form (WISC IVSF score) subjects whose scores are less than 80.
To be administered by a psychiatrist or a clinical psychologist.
2.With the history of diagnosis with previous cognitive development delay.
3.Research participants with known hypersensitivity to the other medications. History of alcohol or drug abuse by the research participant.
4.Where the immediate concern is around another Primary psychiatric diagnoses other than ADHD.
5.Diagnosis of psychiatric comorbidities, except for simple phobia, adjustment disorders, learning disorders, oppositional defiant disorder, sleep disorders, mild anxiety and or mild depressions.
6.History of seizures (except for mild febrile seizures) within 2 years from the time of recruitment.
7.Diagnosis of Tourette Syndrome and chronic tics
8.Research participants who are making use of drugs for the treatment of ADHD in the last three months.
9.Research participants who are making use of anticonvulsants, antidepressants, and antipsychotics up to 6 weeks prior to study entry or during the same.
10.History of past or present pregnancy as confirmed by the participant who have attained menarche.
11.Patients at identified risk of suicide through clinical interview.
12.Children or adolescents with ADHD predominantly hyperactive or impulsive
13.Other conditions considered by the investigator as reasonable for disqualification of the subjectâ??s participation in the study. (To be administered by a clinical psychologist)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢ ADHD symptoms as measured by the SNAP IV <br/ ><br>â?¢ CGI I Scale scores <br/ ><br>Timepoint: â?¢ Timeframe on week 0,6,14 and 28 <br/ ><br>â?¢ Timeframe on week 0,6,14 and 28
- Secondary Outcome Measures
Name Time Method â?¢ Computer based Continuous Performance Test scores <br/ ><br>â?¢ Rey Auditory Verbal Learning Test (RAVLT) scoresTimepoint: â?¢Timeframe on week 0,14 & 28 <br/ ><br>â?¢Timeframe on week 0,14 & 28 <br/ ><br>