跳至主要内容
临床试验/CTRI/2024/08/071939
CTRI/2024/08/071939尚未招募3 期

A Randomized controlled clinical trial to study the Medhya effect of BRAHMI (Bacopa Monnieri) churna in terms of WORKING MEMORY in school going children.

Dr Sachin Tulshiram Gole1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Improvement in

研究概览

简要总结

The term working memory can be defined as the ability to hold, manipulate and store information for short period of time.Working memory is crucial for academic performance as it is an important part of executive functioning (example-planning, initiating, task monitoring and organisation), at school the areas of learnings that are greatly affected by poor working memory are maths problems, reading comprehension, complex problem solving, remembering teachers’ instructions, recalling rules to a game, taking down notes in classroom and test taking.around 20% of the children suffer poor academic performance and low working memory can be one of the reason. which can cause emotional and behavior problem in children. To improve working memory Ayurveda mentions the use of "Medhajanan dravya (3)" for enhancing intellect and memory. People in Indian region often apply Shankhpushpi*.* the drug brahmi (Bacopa monnieri) a wide variety of neuroprotective herbal plants have been reported.  It has been described as a brain tonic and recommended for the management anxiety, poor cognition, and lack of concentration. By filling the knowledge gap, the study can provide valuable insights into the potential benefits of Brahmi Churna and its role in managing Working memory. Including patients within the school-going age group (6-13 years) who fulfill the PGI children memory Scale for working memory , patients are selected irrespective of sex, socio-economic status, and community helps in achieving a diverse and representative sample, enhancing the generalizability of the study findings, written consent from parents ensures ethical compliance and transparency in the treatment process. SAMPLE SIZE using formula by Daniel 1999, the calculated sample size is 31. Simple Random Sampling technique will be used. Total 62 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group).  Brahmi Churna  Group A (trial group) and Shankhpushpi Churna  Group B(Control group) will be given to patients. Trial and control drugs will be purchased from GMC certified pharmacy. Both drugs will be administered in Churma Form  for 28 days. All SOP of Churna  Vidhi will be strictly followed during and after treatment. Observations will be done on day 0, day 14 and day 28. Null hypothesis(H0):   Brahmi churna (bacopa monnieri) is not effective in improving working memory in Children between the age group of 6yrs to 13yrs

Alternative Hypothesis(H1):      Brahmichurna (bacopa monnieri) is effective in improving the working memory in Children between the age group of 6yrs to 13yrs.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • Children of the age group 6 to 13 years with intelligent quotient more than 85 as per the scoring in Binet Kamath intelligence scale.
  • Children with working memory deficit as per PGI children memory scale average percentile of 4 subtests between 0-
  • recent memory B.
  • immediate memory C.
  • attention and concentration D.
  • visual retention
  • Selection of patient is irrespective of their sex, religion and socioeconomic status.

排除标准

  • Mental retardation
  • Learning disability
  • Attention deficit hyperactivity disorder
  • Autism spectrum disorder
  • Gross Developmental delay
  • Visual and auditory impairment.
  • Age group less than 6 yrs and more than 13 yrs.

结局指标

主要结局

Improvement in

时间窗: At baseline and 4 weeks assessment will be done PGI Children Memory Scale

1 Recent memory

时间窗: At baseline and 4 weeks assessment will be done PGI Children Memory Scale

2 Attention and Concentration

时间窗: At baseline and 4 weeks assessment will be done PGI Children Memory Scale

3 Immediate Recall

时间窗: At baseline and 4 weeks assessment will be done PGI Children Memory Scale

4 Visual Retention percentile of PGI Children Memory Scale

时间窗: At baseline and 4 weeks assessment will be done PGI Children Memory Scale

次要结局

未报告次要终点

研究者

发起方
Dr Sachin Tulshiram Gole
申办方类型
Other [Self Individual.]
责任方
Principal Investigator
主要研究者

Dr Sachin Tulshiram Gole

SMBT Ayurved College and Hospital

研究点 (1)

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