| CTRI Number |
CTRI/2018/05/014267 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to See the Effect Of Medicated Ghee(cow ghee infused with herbal medicines) as Against Plain Cow Ghee in Improving Learning Ability and Memory Of Healthy School Going Children. |
|
Scientific Title of Study
|
A Study of Medhya Activity of Vachadi Ghrita on Learning And Memory of High School Children. |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Asmita Wele |
| Designation |
HOD, Dept. of RSBKV [Ayurveda Pharmacology] |
| Affiliation |
|
| Address |
Dept. of Rasashastra and Bhaishajya Kalpana, Bharati Vidyapeeth Deemed University College of Ayurved, Pune-Satara road, Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9923356086 |
| Fax |
|
| Email |
asmita.wele@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrachi Patki |
| Designation |
BAMS,MD Scholar |
| Affiliation |
|
| Address |
Dept. of Rasashastra and Bhaishajya Kalpana, Bharati Vidyapeeth Deemed University College of Ayurved, Pune-Satara road, Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9665092064 |
| Fax |
|
| Email |
prapatki11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrachi Patki |
| Designation |
BAMS,MD Scholar |
| Affiliation |
|
| Address |
Dept. of Rasashastra and Bhaishajya Kalpana, Bharati Vidyapeeth Deemed University College of Ayurved, Pune-Satara road, Pune 411043
MAHARASHTRA
411043
India |
| Phone |
9665092064 |
| Fax |
|
| Email |
prapatki11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University |
|
|
Primary Sponsor
|
| Name |
Dept of Rasashastra and Bhaishajya Kalpana Bharati Vidyapeeth Deemed University College of Ayurved |
| Address |
Pune-Satara road, Pune 411043 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Prof Dr Asmita Wele |
Dept. of Rasashastra and Bhaishajya Kalpana& Bharati Ayurved Hospital, |
Dept. of Rasashastra and Bhaishajya Kalpana& Bharati Ayurved Hospital, Bharati Vidyapeeth Deemed University College of Ayurved, Pune-Satara road, Pune 411043
Pune
MAHARASHTRA |
9923356086
asmita.wele@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDUCOA-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Assessing learning and Memory ability of healthy adolescent children of age between 10-16 years. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Study group –Vachadi Ghrita
|
1.Vachadi Ghrita-10gm in Morning with powdered sugar followed by lukewarm water -orally
|
| Comparator Agent |
2..Positive Control group –Goghrita |
2..Goghrita-10gm in Morning with powdered sugar followed by lukewarm water -orally |
| Comparator Agent |
3.Plain control-No drug is given |
No drug is given |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy subjects of either sex
2.Subjects attending school regularly and willing to take part in the project
3.Age group 10-16 years
4.Students of matching socio-economic class
|
|
| ExclusionCriteria |
| Details |
1.Subjects not attending school
2.Subjects attending school but not willing to take part in the project.
3.Subjects with any physical and or psychological disorders.
4.Students having learning disabilities, and learning disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Increase in z-score of ‘Test of Higher Mental Ability in Science’ will indicate improvement in Higher Mental Ability in science in 30 days.
2.Increase in Numerical Ability Quotient (NAQ) of ‘Numerical Ability Test’ will indicate improvement in Numerical ability.
|
1.Increase in z-score of ‘Test of Higher Mental Ability in Science’ will indicate improvement in Higher Mental Ability in science in 30 days.
2.Increase in Numerical Ability Quotient (NAQ) of ‘Numerical Ability Test’ will indicate improvement in Numerical ability.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in Weight
2.Change in appetite
3.Change in Bowel Habits
4.Changes in Skin |
30 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
06/07/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is Non-randomized, placebo Active Controlled
trial. Study
focuses on Effect Of Medicated Ghee on enhancement of memory. This
study consists of 3 groups of 30 students each. Before
administration of ghee pre assessment learning and memory tests are carried out
on day 0 for all 3 groups. From day 1st to day 30 th Medicated ghee
is administered to Group A (Study Group), Cow ghee is administered to Group B (Active
Control Group) and no ghee is given to group C(Plain Control). On day 31st post
assessment learning and memory tests are taken. Primary outcome measures will
be Increase in z-score of ‘Test of Higher Mental Ability in Science’ and that will
indicate improvement in Higher Mental Ability, Increase in Numerical Ability Quotient (NAQ) of ‘Numerical Ability
Test’ will indicate improvement in Numerical ability. Total study duration is of 32
days.
|