| CTRI Number |
CTRI/2021/07/034735 [Registered on: 09/07/2021] Trial Registered Prospectively |
| Last Modified On: |
02/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Shatavari churn on improvement of intelligence of school going children |
|
Scientific Title of Study
|
An open randomized control clinical study on efficacy of Shatavari churna as medhya rasayana in improvement of intelligence quotient in school going children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Mohanrao Gaikwad |
| Designation |
PG scholar Kaumaryabritya |
| Affiliation |
Hon shri Annasaheb dange Ayurved medical college and post graduate and research center, Ashta |
| Address |
Department of kaumaryabritya Hon shri Annasaheb Dange Ayurved medical college and post graduate and research Center, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9028796277 |
| Fax |
|
| Email |
snehalgaikwad3190@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAbhijit Bharamgonda |
| Designation |
Reader |
| Affiliation |
Hon shri Annasaheb Dange Ayurved medical college and post graduate and research Center, Ashta |
| Address |
Department of kaumaryabritya Hon shri Annasaheb Dange Ayurved medical college and post graduate and research Center, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
8149980338 |
| Fax |
|
| Email |
ayuabhi108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal Mohanrao Gaikwad |
| Designation |
PG scholar Kaumaryabritya |
| Affiliation |
Hon shri Annasaheb dange Ayurved medical college and post graduate and research center, Ashta |
| Address |
Department of kaumaryabritya Hon shri Annasaheb Dange Ayurved medical college and post graduate and research Center, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9028796277 |
| Fax |
|
| Email |
snehalgaikwad3190@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon shri Annasaheb Dange Ayurved medical college and post graduate and research center, Ashta |
|
|
Primary Sponsor
|
| Name |
Hon shri Annasaheb Dange Ayurved medical college and post graduate and research center Ashta |
| Address |
Hon shri Annasaheb Dange Ayurved medical college and post graduate and research center, Ashta |
| 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 |
| Snehal Mohanrao Gaikwad |
Dhanwantari Hospital Ashta |
Department of kaumaryabritya Hon shri Annasaheb Dange Ayurved medical college and post graduate and research center, Ashta
Sangli
MAHARASHTRA |
9028796277
snehalgaikwad3190@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Good |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shatavari churn |
Dose 0.9gm to1.5gm for 6month Shatavari churn orally with anupan Ghrit and Madhu once a day |
| Comparator Agent |
Yashtimadhu churn |
Dose 1.2gm to 2gm for 6month Yashtimadhu churn orally with anupan kshir once a day |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy school going children with age 6-10 years. Healthy school going children with average and bellow average school performance. Child with IQ above 70 and bellow 109. |
|
| ExclusionCriteria |
| Details |
Chronic debilitating illness. Children with mental retardation. Psychologically ill diagnosed cases. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Shatavari medhya rasayana in improvement in IQ of school going children |
6month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the concept of medhya and intelligence quotient |
6 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
17/07/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I am Snehal Mohanrao Gaikwad PG scholar Kaumarbhritya trying to evaluate the efficacy of Shatavari churn on improvement of IQ in school going children. |