| CTRI Number |
CTRI/2019/09/021110 [Registered on: 06/09/2019] Trial Registered Prospectively |
| Last Modified On: |
11/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To determine the effects of investigational product for the treatment of ADHD in children and teens. |
|
Scientific Title of Study
|
Effects of a standardized extract from Bacopa monnieri on the treatment of attention deficit & hyperactivity disorder in children and adolescents (ADHD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NR-HB-01.19 version 1. Dated 18 jan 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H Chandrashekar |
| Designation |
Professor and Head |
| Affiliation |
Victoria Hospital, Bangalore Medical College and Research Institute |
| Address |
Department of Psychiatry, Victoria Hospital, Bangalore Medical College and Research Institute, KR Road, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9845105373 |
| Fax |
|
| Email |
chanag61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharathi B |
| Designation |
Research Officer |
| Affiliation |
Natural Remedies Pvt. Ltd. |
| Address |
Plot No. 5B, Veerasandra Indl. Area,
19th K.M. Stone, Hosur Road,
Electronic City Post,
Bangalore
Bangalore
KARNATAKA
560 100
India |
| Phone |
7338274337 |
| Fax |
|
| Email |
bharathi.b@naturalremedy.com |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
Director |
| Affiliation |
Syncorp Clincare Technologies Pvt. Ltd. |
| Address |
186/2 Tapaswiji Arcade, 2nd floor,
BTM Layout 1st Stage,
Hosur Main Road,
Bangalore
Bangalore
KARNATAKA
560 068
India |
| Phone |
8049788118 |
| Fax |
|
| Email |
subham@syncorp.in |
|
|
Source of Monetary or Material Support
|
| Natural Remedies Private Limited |
|
|
Primary Sponsor
|
| Name |
Natural Remedies Private Limited |
| Address |
Plot No. 5B, Veerasandra Indl. Area,
19th K.M. Stone, Hosur Road,
Electronic City Post,
Bangalore – 560 100, India
|
| Type of Sponsor |
Other [Herbal Healthcare company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr H Chandrashekar |
Bangalore Medical College and Research Institute |
Department of Psychiatry, Victoria Hospital,
Bangalore Medical College and Research Institute
KR road.
Bangalore
KARNATAKA |
9845105373
chanag61@gmail.com |
| Dr Sreedhara KC |
Deepashri Hospital (Rehab/ Deaddiction/ Old age) |
No.86, 2nd Main, 16th D Cross, Nagarbhavi, Bangalore - 560072, Near Malagala Inner Ring Road Under Pass
Bangalore
KARNATAKA |
9481574797
deepashrihospitalcr@gmail.com |
| Dr Ruchi Gupta |
Santosh Hospital |
6/1, Promenade Road, Near Coles Park, Pulikeshi Nagar, Bengaluru, Karnataka 560005
Bangalore
KARNATAKA |
9880051351
drruchibrise@gmail.com |
| Dr Johnson Pradeep R |
St. Johns Hospital and Research Institute |
Department of Psychiatry,
Sarjapura Road, Near Koramangala Water Tank.
Bangalore
KARNATAKA |
9632175933
drjohnsonpradeep@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ashraya Medinove Pvt. Ltd. Institutional Ethics Committee |
Submittted/Under Review |
| Ethics Committee Bangalore Medical College and Research Institute. |
Submittted/Under Review |
| Institutional Ethics Committee,St.Johns Medical College and Hospital |
Approved |
| Santosh Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 effects in improving attention, this plant may be an appropriate treatment for young patients with Attention deficit & hyperactivity disorder.
Duration of administration: 28 weeks.
Route of administration: oral
Dose: 225 mg
|
| Comparator Agent |
Placebo |
The placebo product contains225 mg of pharmaceutical grade excipients per capsule. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ADHD symptoms as measured by the SNAP-IV and CGI-I Scale scores. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Computer-based Continuous Performance Test scores and Rey Auditory Verbal Learning Test (RAVLT) scores.
2. Safety |
1. on week 0, 14 and 28
2. on week 0 and 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)
|
14/09/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study aimed to prove the superiority and tolerability of the investigational product, Cognitus/ Bacomind, compared to placebo in terms of efficacy in the treatment of Attention Deficit & Hyperactivity Disorder (ADHD) in children and adolescents.
|