| CTRI Number |
CTRI/2025/07/091759 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Yashtimadhu moola churna for improving short term memory in children |
|
Scientific Title of Study
|
Open labelled, single arm clinical trial to evaluate the role of yashtimadhu moola churna as a medhya rasayan for improving short term memory in children of Age 12 to 16 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajay Shivajirao Thote |
| Designation |
PhD Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Taluka Panhala District Kolhapur
Kolhapur MAHARASHTRA 416114 India |
| Phone |
9960588434 |
| Fax |
|
| Email |
ajayiamthebest@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vasundhara Borakhade |
| Designation |
Associate Professor and PhD Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Taluka Panhala Distric Kolhapur
Kolhapur MAHARASHTRA 416114 India |
| Phone |
9822885710 |
| Fax |
|
| Email |
vasudhaborakhade@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ajay Shivajirao Thote |
| Designation |
PhD Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Taluka Panhala District Kolhapur
Kolhapur MAHARASHTRA 416114 India |
| Phone |
9960588434 |
| Fax |
|
| Email |
ajayiamthebest@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ajay Shivajirao Thote |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Taluka Panhala District Kolhapur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ajay Shivajirao Thote |
Yashwant Ayurvedic College, Post Graduate Training & Research Centre, Kodoli |
OPD no. 1 - Kayachikitsa, Ground floor. Kolhapur MAHARASHTRA |
9960588434
ajayiamthebest@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yeshawant Ayurved College Kodoli |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School going children of age 12 to 16 i.e. 8th and 9th standard students |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu, Reference: Charak Samhita Chikitsasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of age 12 to 16 specifically school going children of standard 8th and 9th will be selected.
IQ score as per Malin’s Intelligence Scale for Indian Children (MISIC) in between 70 to 109.
200 participants from Marathi medium school and 200 participants from English medium school will be selected.
Subjects will be selected irrespective of gender, religion, and socio-economical condition.
Parent of the subject who give informed written consent will be included. |
|
| ExclusionCriteria |
| Details |
Subjects of age below 12 and above 16 specifically school going children of standard below 8th and above 9th will be excluded.
IQ score as per Malin’s Intelligence Scale for Indian Children (MISIC) below 70 and above 109.
Subjects who are taking any authenticate memory enhancer drug or formulations will be excluded.
Subjects who are taking any treatment from psychiatrist for any mental problem will be excluded.
Subjects who stopped psychiatric treatment in last 3 months will be excluded.
Female participants having irregular menses, PCOS will be excluded. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Short Term Memory
a. Auditory-verbal Short term memory test
b. Visual-verbal Short term visual memory test for Numbers
c. Visual-verbal Short term visual memory test for Words |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Bala
2. Agni
3. Varna
4. Swara
5. Aamay nashan
6. IQ Score as per Malin’s Intelligence Scale for Indian Children (MISIC)
7. Weight
8. BMI |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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)
|
05/08/2025 |
| 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="2" Months="0" 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
|
|
Ayurveda has duly recognized the individuality of Mana and Sharira and
their inseparable and interdependent relation in living body. Mana, Atma and Sharira together
leads to the Ayu of an individual. One who has
balanced Dosha, balanced Agni, and properly
formed Dhatus; proper elimination of Malas,
well-functioning bodily processes, and whose mind, soul and senses are full
of bliss is called a healthy person. Difference in the human and other
living species on the planet earth is the human brain. The human brain is
also responsible for the development of human in all aspect and for this
memory plays an important role. All living species learn everything by remembering
previous experience but humans are more developed than other because of the
intellect. Memory and Intelligence of human makes them superior in all
aspect, which changes the standard of living of humans from time to time.
Ayurveda coined the term Medha which means Dharana
Shakti i.e. Intellectual and / or retention and Rasayan means
therapeutic procedure or preparations that on regular practice which boost
nourishment, health, memory, intellect, immunity and hence longevity.
The Ayurvedic texts
describes a set of rejuvenate to impact biological sustenance to the bodily
tissues. These remedies are called Rasayan which are claimed
to act as micronutrients. Some of these Rasayanas are organ
and tissue specific. Those specific to brain tissue are called Medhya
Rasayan. Medhya Rasayan is a group of four medicinal plants that can
be used singly or in combinations explained by Acharya Charak in
first adhyaya of Charaka Samhita Chikitsasthana i.e.
Rasayan Adhyay. In school life, children are more focused on the
study to have the bright future in life. Students may mugging up the
definitions, formulae or try to remember it by writing it on a paper so many
times to get good grades or marks in the examination. Students will not get
good marks by reading a book one day before exam, they need to study for a
long period of time with consistency before any examination, and like this
long term practice of Medhya Rasayan is required
to enhance the memory.
Four medhya
rasayan are explained by Acharya Charaka. Yashtimadhu is
to taken in the form of churna and aupana is dugdha i.e.
cow milk, which is considered to be palatable among all four medhya
rasayan. Swaras of Mandukparni and Guduchi, kalka of Shankhapushpi is
too explained as a medhya rasayan but swarasa and kalka are
not as palatable as churna in children.
Yashtimadhu is commonly known as Kanthya and kanda i.e.
bark is used for it in day today practice. So I have choose Yashtimadhu
moola churna as a medhya rasayan for research study
as the medhya karma of Yashtimadhu is
neglected though it is explained in Charaka samhita.
|
Dhee, Dhruti and Smruti definitions
given by Chakrapanidatta in Ayurvedadipika,
Arunadatta in Sarvangasundara and Hemadri in Ayurvedarasayan, the
word Smruti is relate with the word memory among Dhee, Dhruti and Smruti.
Exam pattern in our education system is completely based on memory i.e. smaranshakti.
So Yashtimadhu churna is selected for this research study out
of four medhya rasayan dravyas because churna is
palatable and anupana for it is milk thus it will be easy for
the children to take the medicine on daily basis for 3 months of time period. |