A clinical study to compare the Efficacy & Safety of BACOMIND on the treatment of attention deficit and hyperactivity disorder in children and adolescents

Suspended

• Conditions: Attention deficit & hyperactivity disorder (ADHD) in children and adolescents, a mental disorder of the neurodevelopmental Type

• Registration Number: CTRI/2017/11/010325
• Lead Sponsor: Natural Remedies Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-11
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Changes in ADHD symptoms from baseline to 6 months as measured by the SNAP-IV	From Baseline to End of Treatment
2. Changes in CGI-I Scale scores from baseline to 6 months	From Baseline to End of Treatment

Secondary Outcome Measures

Name	Time	Method
1. Change in computer-based Continuous Performance Test from baseline to 6 months	2. Rey Auditory Verbal Learning Test scores

Trial Locations

Locations (3)

Rajalakshmi Multispeciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Rajarajeswari Medical College & Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sapthagiri Institute of Medical Science & Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Rajalakshmi Multispeciality Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Soma Shekhar C

Principal investigator

09482863660

somashekharc123@gmail.com