FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/07/014909 [Registered on: 17/07/2018] Trial Registered Prospectively
Last Modified On: 15/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effectiveness of Yashtimadhu Choorna with milk on health and intelligence in healthy volunteers (school going children) 
Scientific Title of Study   An Open Labeled, Randomized, Two Arm Study Of Effect Of Yashtimadhu Choorna With Milk On Health And Cognitive Parameters In Healthy Volunteers – A School Based Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Shailesh Deshpande 
Designation  Ph. D. Scholar 
Affiliation  Asst. Professor, Dept. of Kayachikitsa, SSAM Pune 
Address  Department of Ayurveda, Tilak Maharashtra Vidyapeeth, Gultekadi, Pune
Sumatibhai Shah Ayurved College, Hadapsar, Pune
Pune
MAHARASHTRA
411 037
India 
Phone  9096082950  
Fax    
Email  dr.vaishalid@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhijit Joshi 
Designation  Guide  
Affiliation  Head of Department  
Address  Department of Ayurveda, Tilak Maharashtra Vidyapeeth, Gultekadi, Pune

Pune
MAHARASHTRA
411 037
India 
Phone  02024403080  
Fax    
Email  ayutmv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaishali Shailesh Deshpande 
Designation  Ph. D. Scholar 
Affiliation  Asst. Professor, Dept. Of Kayachikitsa, SSAM Pune 
Address  Department of Ayurveda, Tilak Maharashtra Vidyapeeth, Gultekadi, Pune
Sumatibhai Shah Ayurved College, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411 037
India 
Phone  9096082950  
Fax    
Email  dr.vaishalid@gmail.com  
 
Source of Monetary or Material Support  
Dr. Vaishali Deshpande Sonai, Shri Adishakti coop. Hsg. So. No. 1, Sr. No. 28/8/5 &6, Chaitanya Nagar, Dhankawadi, Pune - 411043 
 
Primary Sponsor  
Name  Dr Vaishali S Deshpande 
Address  Tilak Maharashtr Vidyapeeth, Gultekadi, Pune  
Type of Sponsor  Other [Ph. D. Scholar, ] 
 
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 Vaishali S Deshpande  Tilak Maharashtra Vidyapeeth  Department of Ayurved, First floor, Gultekadi, Pune
Pune
MAHARASHTRA 
9096082950

dr.vaishalid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, The Late P. G. Nanal Department of Ayurved,Tilak Maharashtra Vidyapeeth, Gultekadi, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health and Cognitive Parameters  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Milk   50 ml BD (in the morning on empty stomach and after dinner) for 3 months 
Intervention  Yashtimadhu Choorna   2.5gm BD (in the morning on empty stomach and after dinner)with 50 ml of milk for 3 months 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1)Apparently healthy volunteers i.e. students of secondary school
2)No significant medical or surgical illness at the time of screening
3)Volunteers and their parents ready for the study and willing for treatment
4)Selection will be irrespective of religion, gender, socioeconomic status, class and standard.
6)Willing to undergo study related procedures
 
 
ExclusionCriteria 
Details  1)Presence of significant medical or surgical illness at the time of screening requiring long term treatment.
2)Volunteers having history of delayed milestones in infancy/childhood
3)K/C/O growth retardation, mentally retarded children.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of consumption of Yashtimadhu Choorna along with milk on cognitive parameters in healthy volunteers in study group on the basis of
1.DLST (digit letter substitution test)
2.SLCT(six letter cancellation test)
3.Improvement in academic performance


2.To evaluate the cognitive parameters in healthy volunteers in control group on the basis of
1.DLST (digit letter substitution test)
2.SLCT(six letter cancellation test)
3.Improvement in academic performance
 
At the baseline (0 Day) and at the end of the study (90th Day) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the cognitive parameters in healthy volunteers in either groups on the basis of
1. DLST (digit letter substitution test)
2. SLCT(six letter cancellation test)
3.Improvement in academic performance
 
At the baseline (0 Day) and at the end of the study (90th Day) 
Assessment of health status on the basis of episodes, severity and duration of illnesses in both groups.   At the baseline (0 Day) and at the end of the study (90th Day) 
Assessment of difference in absent days in school due to illness in both groups.  At the baseline (0 Day) and at the end of the study (90th Day) 
Assessment of change in energy levels, strength and stamina in both groups.   At the baseline (0 Day) and at the end of the study (90th Day) 
Assessment of growth parameters like height and weight in both groups.   At the baseline (0 Day) and at the end of the study (90th Day) 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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 2 
Date of First Enrollment (India)   23/07/2018 
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   None.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is an Open label, Randomized, Multi center, Prospective, Two arm Clinical Study. After obtaining Ethics Committee approval registration at CTRI will be done. After obtaing CTRI registration number, the study will be started. The study will be conducted at Mahatma Phule Vidyaniketan Institution’s Dnyanaprabodhini Madhyamik and Kanishtha Mahavidyalaya, Sasanenagar, Hadapsar Pune 28

Firstly the study design will be explained to the school officials including teachers. After obtaining their consent, parent meeting will be called. The study will be explained in detail to the parents. Each and every possible effort will be taken to answer study related queries. Parents’ attendance will be taken. Also their willingness and correspondence details will be taken. The parents who are willing for participation will be called on next day with their ward for participation eligibility screening.

On screening day, the ascent from child and consent from parent will be taken and then only study related activities will be conducted. At baseline visit, according to randomization, the children will be included in respective groups. One follow up card and one accountability sheet will be issued to each participant. The participant will be instructed to tick on the accountability sheet after consumption of Yashtimadhu Choorna along with milk on daily basis.

Groups
Group A (Study Group):
 the students in this group will be advised to follow their regular routine which they are already following along with consumption of Yashtimadhu Choorna 2.5 gm along with 50 ml of milk , twice in a day for 3 months.

Group B (Control group): the students in this group will be advised to follow their regular routine which they are already following along with consumption of 50 ml of milk twice in a day for 3 months.

Assessment Criteria  
1. Digit Letter Substitution Test (DLST) - at baseline visit and at the end of the study.
2. Six Letter Cancellation Test (SLCT) - at baseline and at the end of the study.

3. Improvement in academic performance - at the baseline and at the end of the study.

Methodology for Assessment parameters

1. Digit Letter Substitution Test (DLST)

a. The DLST worksheet consists of random digits,1-9, in 8 rows and 12 columns.

b.The coding sheet will have instructions about the test with example of substituting a specific letter for each digit 1-9, the same coding will be applied to an entire test group.

c. Subjects will be instructed to make their own choice of letter substitution strategy, whether horizontally, vertically, or selecting a particular digit randomly in the array one at a time.

d.They will be instructed to substitute as many target digits as possible in the specified time of 90 seconds

2. Six Letter Cancellation Test

a.The six letter cancellation task worksheet consists of random alphabets, A-Z, in 14 rows and  22columns.                                                   

b. Subjects will be instructed to seat with the worksheet turned over until the start of the test. All participants to be tested in one group will also be given instruction sheet indicating the six target letters to be cancelled.

c.The instructions will be given regarding cancellation of as many target digits as possible in the specified time of 90 seconds.     

d.They will be given the choice of cancellation strategy to do it horizontally, vertically, or selecting a particular letter one at a time randomly in the array.

e. Finally, after ensuring that they have understood the test by answering all their queries they will be instructed to turn over the worksheet and start the test as the bell rings.

3. Academic improvement  

a. Discussion with school teacher as well as parents will be done.

 b For teacher – the points under discussion will be absenteeism due to illness, attentiveness, energy level, physical fitness, social behavior in class.

c.For parents – the points under discussion will be episodes, severity and duration of illness, energy levels, physical fitness, stamina, social behavior at home.

Accountability - The volunteers in both group shall be inquired and confirmation will be obtained about history of regularity of consumption of Yashtimadhu Choorna with milk/milk with the help of accountability sheet.

Data Analysis - The data obtained through the study will be shared to qualified statistician for performing data analysis. Conclusion will be drawn on the basis of data analysis and study findings.

 

 
Close