| CTRI Number |
CTRI/2017/11/010325 [Registered on: 01/11/2017] Trial Registered Prospectively |
| Last Modified On: |
04/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the Efficacy & Safety of BACOMIND on the treatment of attention deficit and hyperactivity disorder in children and adolescents |
|
Scientific Title of Study
|
A Prospective, Interventional, Multi-centric, Randomized, Double blind, Two-arm, parallel Group, Placebo Controlled Clinical Study to evaluate the Efficacy & Safety of BACOMIND®, a standardized extract from Bacopa monnieri on the treatment of attention deficit and hyperactivity disorder (ADHD) in children and adolescents |
| Trial Acronym |
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|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: ICBio/CR/NRPL/0207/71 Version: 01 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tamil Selvan |
| Designation |
HOD & Professor in Paediatric |
| Affiliation |
Sapthagiri Institute of Medical Science & Research Centre |
| Address |
#15,Chikkasandra,
Hesaragatta Main Road
Bangalore
KARNATAKA
560090
India |
| Phone |
9738877298 |
| Fax |
|
| Email |
drselvantg@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Natural Remedies Pvt. Ltd
Plot No. 5B, Veerasandra Industrial Area,
19th K.M. Stone, Hosur Road,
Electronic City Post,
Bangalore – 560 100, India
|
|
|
Primary Sponsor
|
| Name |
Natural Remedies Pvt Ltd |
| Address |
Plot No. 5B, Veerasandra Industrial Area, 19th K.M. Stone, Hosur Road, Electronic City Post, Bangalore – 560 100, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soma Shekhar C |
Rajalakshmi Multispeciality Hospital |
Department of Paedatrics
#21/1,Lakshmi pura Main road,
opp. Lakshmipura lake , Vidyaranyapura post
Bangalore
KARNATAKA |
09482863660
somashekharc123@gmail.com |
| Sudhir Hebbar |
Rajarajeswari Medical College & Hospital |
Department of Psychiatry
# 202, Kambipura, Mysore Road,
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
09845133229
drsudhirhebbar@gmail.com |
| Dr Tamil Selvan |
Sapthagiri Institute of Medical Science & Research Centre |
Pediatric Department #15,Chikkasandra,
Hesaragatta Main Road
Bangalore
KARNATAKA |
9738877298
drtemilselvan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Instiutional ethics committee DR SomShekhar C |
Approved |
| Rajarajeswari Medical College & Hospital Instiutional Ethics Committee |
Approved |
| Sapthagiri Institute of Medical Science & Research Centre, Instiutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, Attention deficit & hyperactivity disorder (ADHD) in children and adolescents, a mental disorder of the neurodevelopmental Type, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BacoMind®- a standardized dried extract from Bacopa monnieri |
Single oral dose, One Capsule a day in the morning after breakfast for 180 days |
| Comparator Agent |
placebo without active Ingredient |
Single oral dose, One Capsule a day in the morning after breakfast for 180 days |
|
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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 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
|
|
| ExclusionCriteria |
| Details |
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 subject’s participation in the study
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in ADHD symptoms from baseline to 6 months as measured by the SNAP-IV
2. Changes in CGI-I Scale scores from baseline to 6 months
|
From Baseline to End of Treatment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in computer-based Continuous Performance Test from baseline to 6 months
2. Rey Auditory Verbal Learning Test scores
Safety: Blood pressure ), temperature, pulse rate, respiratory rate, physical examination, serum complete blood picture, biochemistry (blood glucose, total protein, albumin, transaminases AST and ALT, ALP, creatine kinase (CK), creatinine, urea, uric acid, total bilirubin.
|
From Baseline to End of Treatment |
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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" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2017 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
A Prospective Interventional Multicentric Randomised Double Blind Two arm parallel group placebo controlled clinical study to evaluate the efficacy and safety of Bacomind a standardised extract from Bacopa Monnieri on the treatment of Attention deficit and Hyperactivity disorder in children and Adolescents.
Total of 136 subjects
The study duration is for 180 days. Study is suspended because of large population ( in pediatric group of subjects ) and also the duration of study is more so subjects are not able to the site for next visits so we have suspended this study.
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