| CTRI Number |
CTRI/2024/05/067259 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Medha Sukta Mantra Listening] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Medha Sukta Mantra on Cognition in Different Deha Prakriti Individuals |
|
Scientific Title of Study
|
An Open-Label Comparative Interventional Study to Analyze The Effect of Medha Sukta Mantra on Cognition in Different Deha Prakriti Individuals |
| 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 Devalkumar Shah |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9714111997 |
| Fax |
|
| Email |
devalshah725@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaidehi V Raole |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824284371 |
| Fax |
|
| Email |
vaidehi.raole@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devalkumar Shah |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat
GUJARAT
391760
India |
| Phone |
9714111997 |
| Fax |
|
| Email |
devalshah725@gmail.com |
|
|
Source of Monetary or Material Support
|
| 105 Ground Floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat India 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat 391760 India |
| 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 |
| Dr Devalkumar Shah |
Parul Institute of Ayurved and Hospital |
105 Ground Floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat 391760 India
Vadodara
GUJARAT |
9714111997
devalshah725@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | routine lifestyle | The comparartor arm will not be given the "Medha Sukta Mantra" for listening. | | 2 | Intervention Arm | Procedure | - | mantra-cikitsA, मनà¥à¤¤à¥à¤°-चिकितà¥à¤¸à¤¾ | (Procedure Reference: ch su 11, Procedure details: the interventional arm will be given "Medha Sukta Mantra" for listening for 14 minutes/day for 48 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
-Apparently Healthy Volunteers Will be Selected from University Campus
-Age Group of 18-30 Years Irrespective of Cast,Religion and Gender
|
|
| ExclusionCriteria |
| Details |
-Persons Having any Systemic or Psychological Diseases
-Persons Who are Taking Any Type of Medications
-Persons Having Any Addictions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Cognition in different Deha Prakriti Individuals |
baseline will be take prior to the intervention and
then assessment after 48 days intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="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
|
- Good Cognitive Ability Will Help to Improve Social Interaction, Good Job Profile, Good Educational Standard, Good Level of Understanding Life and Psychological Counselling for Increasing the Standards of Intelligence, So by Knowing The Relation Between Prakriti and Cognition will Help In Above Mentioned Areas- So Present Study will Help us to Corelate an Appropriate Relation of Cognition with Prakriti And Establish that There is a Significant Effect of Medha Sukta Mantra on Cognition in Different Deha Prakriti Individuals
|