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CTRI Number  CTRI/2024/08/071939 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Bacopa monnieri and Working Memory in children A Clinical Trial  
Scientific Title of Study   A Randomized controlled clinical trial to study the Medhya effect of BRAHMI (Bacopa Monnieri) churna in terms of WORKING MEMORY in school going children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sachin Tulshiram Gole 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri 422403

Nashik
MAHARASHTRA
422403
India 
Phone  08408058296  
Fax    
Email  sachingole8296@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Sachin Prakash Gwalani 
Designation  Associate Professor 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri 422403,India

Nashik
MAHARASHTRA
422403
India 
Phone  9834570287  
Fax    
Email  sachin.gwalani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sachin Tulshiram Gole 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri 422403

Nashik
MAHARASHTRA
422403
India 
Phone  08408058296  
Fax    
Email  sachingole8296@gmail.com  
 
Source of Monetary or Material Support  
Department of Kaumarbhritrya Smbt Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri-422403, India 
 
Primary Sponsor  
Name  Dr Sachin Tulshiram Gole 
Address  Department of kaumarbhritya SMBT Ayurved College and Hospital Dhamangaon Igatpuri Nashik 422403 
Type of Sponsor  Other [Self Individual.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sachin Tulashiram Gole  SMBT Ayurved College and Hospital  OPD No 12 Department of kaumarbhritya SMBT Ayurved College and Hospital Dhamangaon Igatpuri 422403
Nashik
MAHARASHTRA 
08408058296

sachingole8296@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children With Normal IQ But Low Working Memory 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shankpushpi, Reference: भावप्रकाश निघण्टु .गुडुच्यदिवर्ग/269-27, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Madhu And Ghrita), Additional Information: -Dose will be given According to age
2Intervention ArmDrugClassical(1) Medicine Name: Brahmi, Reference: भावप्रकाश निघण्टु.गुडुच्यदिवर्ग/२८, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Madhu And Ghrita), Additional Information: -Dose will be according to age
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1. Children of the age group 6 to 13 years
with intelligent quotient more than 85 as
per the scoring in Binet Kamath
intelligence scale.
2. Children with working memory deficit as
per PGI children memory scale average
percentile of 4 subtests between 0-20.
A. recent memory
B. immediate memory
C. attention and concentration
D. visual retention 3. Selection of patient is irrespective of
their sex, religion and socioeconomic
status.
 
 
ExclusionCriteria 
Details  1. Mental retardation
2. Learning disability
3. Attention deficit hyperactivity disorder
4. Autism spectrum disorder
5. Gross Developmental delay
6. Visual and auditory impairment.
7. Age group less than 6 yrs and more than 13
yrs.
8. Epilepsy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in
1 Recent memory
2 Attention and Concentration
3 Immediate Recall
4 Visual Retention percentile of PGI Children Memory Scale  
At baseline and 4 weeks assessment will be done PGI Children Memory Scale  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 3 
Date of First Enrollment (India)   15/08/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 monnieriis not effective in improving working memory in Children between the age group of 6yrs to 13yrs

Alternative Hypothesis(H1):      Brahmi churna (bacopa monnieriis effective in improving the working memory in Children between the age group of 6yrs to 13yrs.


 
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