| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children With Normal IQ But Low Working Memory |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shankpushpi, Reference: à¤à¤¾à¤µà¤ªà¥à¤°à¤•ाश निघणà¥à¤Ÿà¥ .गà¥à¤¡à¥à¤šà¥à¤¯à¤¦à¤¿à¤µà¤°à¥à¤—/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 | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmi, Reference: à¤à¤¾à¤µà¤ªà¥à¤°à¤•ाश निघणà¥à¤Ÿà¥.गà¥à¤¡à¥à¤šà¥à¤¯à¤¦à¤¿à¤µà¤°à¥à¤—/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 monnieri) is not effective in improving working memory in Children between the age group of 6yrs to 13yrsAlternative Hypothesis(H1): Brahmi churna (bacopa monnieri) is effective in improving the working memory in Children between the age group of 6yrs to 13yrs. |