| CTRI Number |
CTRI/2019/04/018377 [Registered on: 02/04/2019] Trial Registered Prospectively |
| Last Modified On: |
01/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Assessment of I.Q. in Rakta Sara purusha individual With Special Reference to Medha |
|
Scientific Title of Study
|
OBSERVATIONAL STUDY OF MEDHA IN RAKTA SARA PURUSHA WITH THE SPECIAL REFERENCE TO I.Q. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JAIMIN B SHAH |
| Designation |
P.G. SCHOLAR-2ND YEAR, KRIYA SHARIR |
| Affiliation |
PARUL UNIVERSITY OF AYURVEDA |
| Address |
Kriya Sharir Department,Parul uni.,at post. Limda, Tal. Waghodia-391760 Dist.-Vadodara
AT.PO.-AKRUND
TA-DHANSURA DIST.-ARAVALLI
PINCODE-383260
STATE-GUJRAT
COUNTRY-INDIA
Vadodara
GUJARAT
391760
India |
| Phone |
9586893292 |
| Fax |
|
| Email |
jaiminshah26190@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUNIL PUNDLIK NIKHATE |
| Designation |
Associate Professor-H.O.D.,KRIYA SHARIR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
Associate Professor, Kriya Sharir DEPT., Parul Institute Of Ayurveda, at post. Limda, Tal. Waghodia-391760 Dist.-Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9521166422 |
| Fax |
|
| Email |
dr.spnikhate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUNIL PUNDLIK NIKHATE |
| Designation |
Associate Professor-H.O.D.,KRIYA SHARIR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
Associate Professor, Kriya Sharir DEPT., Parul Institute Of Ayurveda, at post. Limda, Tal. Waghodia-391760 Dist.-Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9521166422 |
| Fax |
|
| Email |
dr.spnikhate@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL INSTITUTE OF AYURVEDA
P.O.LIMDA,TA. WAGHODIA,DIST.-VADODARA-391760,GUJRAT,INDIA. |
|
|
Primary Sponsor
|
| Name |
DrJAIMIN B SHAH |
| Address |
Kriya Sharir Department,Parul uni.,at post. Limda, Tal. Waghodia-391760 Dist.-Vadodara |
| 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 |
| DrSUNIL PUNDLIK NIKHATE |
PARUL INSTITUTE OF AYURVEDA |
Kriya Sharir Department,Parul uni.,at post. Limda, Tal. Waghodia-391760 Dist.-Vadodara
Vadodara
GUJARAT |
9521166422
dr.spnikhate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PU/PIA/IECHR/2019/3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Rakta Dhatu Shara Purusha and Revised Bhatias Short Battery of Perf. Test Of S.K. Verma |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Volunteers Irrespective Of Sex With Age group of 20-40 Years. |
|
| ExclusionCriteria |
| Details |
1-People Below 20 and above 40 years of age
2-Person With Severe Or Chronic Disease, Organic, Systemic, Illness, Psychopathology
3-Other Sarata Excluded Except Rakta Sara |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
|
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| assess and evaluate good I.Q. level in healthy volunteers by study of rakta sara purusha |
one time study |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| to rule out objective parameter for Medha in the form of I.Q. in Rakta Sara Purusha |
one time study |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2019 |
| Date of Study Completion (India) |
30/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NON YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
I did association test for Rakta sara purusha and other parameters and have concluded that there is significant association between Rakta sara purusha and gender of the person also Rakta sara purusha and I.Q.of the person and Rakta sara purusha doesn’t have any association with other parameters like Age of the person, sleeping type, Ahara, Rasa-abhiruchi and habits(Addiction).Also calculate correlation coefficient for Rakta sara purusha and I.Q. of the person, perform chi-square test to check association. base on test results and calculations we rejected our null hypothesis and conclude that there is significant association between Rakta sara purusha and I.Q.(Medha) of the person.. . |