CTRI/2017/11/010325暂停不适用
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
Natural Remedies Pvt Ltd3 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2017年3月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 136
- 试验地点
- 3
- 主要终点
- 1. Changes in ADHD symptoms from baseline to 6 months as measured by the SNAP-IV
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •Voluntary agreement to participate in the study
- •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)
- •Subjects who have not participated in a similar investigation in the past four weeks
- •Subject is willing and able to comply with all trial requirements.
排除标准
- •Legal guardians for the child andresearch participants who expressed a desire to not participate in this study
- •Research participants with hypersensitivity to the study drug
- •History of alcohol or drug abuse by the research participant
- •Primary psychiatric diagnoses other than ADHD using MINI-KID questionnaire
- •Diagnosis of psychiatric comorbidities, except for simple phobias, adjustment disorder, motor disorder, learning disorder, oppositional defiant disorder and sleep disorder
- •Diagnosis of Tourette Syndrome and chronic tics
- •Research participants who are making use of drugs for the treatment of ADHD
- •Children/adolescents with ADHD predominantly hyperactive/impulsive
- •Research participants who are making use of anticonvulsants, antidepressants and antipsychotics up to 1 week prior to study entry or during the same
- •Other conditions considered by the investigator as reasonable for disqualification of the subject’s participation in the study.
结局指标
主要结局
1. Changes in ADHD symptoms from baseline to 6 months as measured by the SNAP-IV
时间窗: From Baseline to End of Treatment
2. Changes in CGI-I Scale scores from baseline to 6 months
时间窗: From Baseline to End of Treatment
次要结局
- 1. Change in computer-based Continuous Performance Test from baseline to 6 months(2. Rey Auditory Verbal Learning Test scores)
研究者
研究点 (3)
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