| CTRI Number |
CTRI/2020/12/030002 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
22/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
SURVEY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A SURVEY ON PRAKRITI (PHYSICALCONSTITUTION)AND ITS RELATION WITH ASHRU(TEARS) |
|
Scientific Title of Study
|
A Survey on prakriti and its relation with ashru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavya Rathava |
| Designation |
P.G.Scholar |
| Affiliation |
J.S.Ayurveda Mahavidhyalaya NADIAD |
| Address |
Rachana sharir department of J.S.AYURVED MAHAVIDHYALAYA COLLAGE ROAD NADIAD KHEDA GUJRAT 387001 INDIA
J.S.Ayurveda Mahavidhyalaya nadiad. dist kheda
Kheda
GUJARAT
384355
India |
| Phone |
9409022032 |
| Fax |
|
| Email |
rathavab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drswati Bedekar |
| Designation |
Professor |
| Affiliation |
J.S.AYURVED MAHAVIDHYALAYA |
| Address |
Rachana sharir department of J.S.AYURVED MAHAVIDHYALAYA COLLAGE ROAD NADIAD KHEDA GUJRAT 387001 INDIA
J.S.AYURVED MAHAVIDHYALAYA COLLAGE ROAD NADIAD KHEDA GUJRAT 387001 INDIA
Kheda
GUJARAT
387001
India |
| Phone |
9881693240 |
| Fax |
|
| Email |
lswati68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drswati Bedekar |
| Designation |
Professor |
| Affiliation |
J.S.AYURVED MAHAVIDHYALAYA |
| Address |
Rachana sharir department of J.S.AYURVED MAHAVIDHYALAYA COLLAGE ROAD NADIAD KHEDA GUJRAT 387001 INDIA
Panch Mahals
GUJARAT
387001
India |
| Phone |
9881693240 |
| Fax |
|
| Email |
lswati68@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of shalakyatantra of j.s. ayurveda mahavidhyalaya nadiad |
|
|
Primary Sponsor
|
| Name |
JSAyurveda Mahavidhyalaya |
| Address |
college road nadiad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 BHAVYA RATHAVA |
J.S.AYURVEDA MAHAVIDHYALAY |
Rachana sharir department of J.S.AYURVED MAHAVIDHYALAYA COLLAGE ROAD NADIAD KHEDA GUJRAT 387001 INDIA
Kheda
GUJARAT |
9409022032
rathavab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics coommiitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Both genders in the age group between 18 to 40 years. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Hundred Healthy volunteers will be selected.
2)Both genders in the age group between 18 to 40 years.
|
|
| ExclusionCriteria |
| Details |
1)Individual having age below18 year and above 40 year will be excluded.
2)Pregnant women.
3)Individual having any disease related to eye.
4)Individual who have undergone eye surgeries.
5)Auto immune diseases.
6)Who are having refractive errors?
7)Congenital anomalies.
8)Postmenopausal women.
9)Person using mobile or computer more than 3 hour/day.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| schirmers test value vary in 15mm to 35mm in different individuals |
5 minutes for every individuals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any relation seen in between schirmers test value and prakriti in individuals |
30 minutes for every individual |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2021 |
| Date of Study Completion (India) |
20/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/05/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This will be submitted in a form of dissertatin and may published in any peer review journal with prior permission of gujarat ayurveda university |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is observational servey type of study. According to our Ayurvedic classics our Acharyas have given many tools to assesses the Prakruti, but no where Ashru has been mentioned in that list of tools. Now a days in this catastrophic era due to extensive exposure of eye to different types of Video display terminals (VDT), which influences the Ashru. there is a need to study any relation between ashru and prakriti. Aim of the study is To study the role of Ashru in Prakriti Pareekshana . As per my knowledge till now only one study is done on Ashru and Ashru Marga, so in the present survey we would like to study Ashru and its relationship with Prakriti .In this study 100 healthy volunteers will be selected aged between 18 to 40 years.Written informed Consent and Case record proforma will be prepared. Prakriti of the selected volunteers will be accessed by using CCRAS format of prakritiparikshana.Ashru of the selected volunteers will be accessed by Schirmers test. Schirmers test::- It measures total tear secretions. It is performed with the help of a 5 × 35 mm strip of Whatman-41 filter paper which is folded 5 mm from one end and kept in the lower fornix at the junction of lateral one-third and medial two-thirds. Then asked patient to look up and not to blink or close the eyes. After 5 minutes wetting of the filter paper strip from the bent end is measured. Statistical analysis will done by ANOVA test. |