| CTRI Number |
CTRI/2023/08/056451 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Bacopa monnieri on ADHD in children and adolescents. |
|
Scientific Title of Study
|
Efficacy & safety of a standardized extract from Bacopa monnieri in children and adolescents with attention deficit hyperactivity disorder (ADHD): A randomized, double blind, placebo-controlled with an extended open label study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0018-008 V1.0 17 May 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Gupta |
| Designation |
Consultant- Psychiatrist |
| Affiliation |
Santosh Hospital |
| Address |
Department of Psychiatry,6/1,
Promenade Road, Near
Coles Park, Frazer
Town, Bengaluru
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560005
India |
| Phone |
9880051351 |
| Fax |
|
| Email |
drruchibrise@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Consultant- Psychiatrist |
| Affiliation |
Santosh Hospital |
| Address |
Department of Psychiatry,6/1,
Promenade Road, Near
Coles Park, Frazer
Town, Bengaluru
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560005
India |
| Phone |
9880051351 |
| Fax |
|
| Email |
drruchibrise@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Consultant- Psychiatrist |
| Affiliation |
Santosh Hospital |
| Address |
Department of Psychiatry,6/1,
Promenade Road, Near
Coles Park, Frazer
Town, Bengaluru
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560005
India |
| Phone |
9880051351 |
| Fax |
|
| Email |
drruchibrise@gmail.com |
|
|
Source of Monetary or Material Support
|
| Natural Remedies Pvt. Lt
Plot No 5B, Veerasandra Industrial Area, 19 K M Stone, Hosur Road, Electronic City Post, Bangalore 560100, India |
|
|
Primary Sponsor
|
| Name |
Natural Remedies Pvt. Lt |
| Address |
Natural Remedies Pvt. Lt
Plot No 5B, Veerasandra Industrial Area, 19 K M Stone, Hosur Road, Electronic City Post, Bangalore 560100, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Gupta |
Santosh Hospital |
Department of General Medicine, 6/1,
Promenade Road, Near Coles Park, Frazer Town, Bengaluru,
Karnataka- 560005, India.
Bangalore
KARNATAKA
560005
India
Bangalore
KARNATAKA |
9880051351
drruchibrise@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Santosh Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F908||Attention-deficit hyperactivity disorder, other type, (2) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitus Bacomind |
one capsule of Cognitus/ Bacomind in the morning
after breakfast, for 28 weeks |
| Comparator Agent |
Microcrystalline Cellulose |
One capsule in the morning after
breakfast, for 14 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
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)
|
|
| ExclusionCriteria |
| Details |
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 subject’s participation in the study. (To be administered by a clinical psychologist)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• ADHD symptoms as measured by the SNAP IV
• CGI I Scale scores
|
• Timeframe on week 0,6,14 and 28
• Timeframe on week 0,6,14 and 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Computer based Continuous Performance Test scores
• Rey Auditory Verbal Learning Test (RAVLT) scores |
•Timeframe on week 0,14 & 28
•Timeframe on week 0,14 & 28
|
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Attention deficit &
hyperactivity disorder (ADHD) is a common childhood disorder characterized by
persistent symptoms of lack of attention, hyperactivity, and impulsivity, being
associated to decreased school performance and academic success and social rejection,
and in adults, it is related to worst performance and success in professional
field. Children with ADHD have a significantly greater probability than their
peers to develop conduct disorders during adolescence and personality disorders
in adulthood. Ample number of resources are available in the public domain on the positive effectiveness of Bacopa
monnieri in improving attention. Also many literature suggest this plant extract may be effective in treating young patients with Attention deficit &
hyperactivity disorder. |