| CTRI Number |
CTRI/2019/02/017855 [Registered on: 27/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
FIND THE RELATION BETWEEN BEHAVIOUR PATTERN AND TISSUE DEVELOPMENT |
|
Scientific Title of Study
|
A Study to evaluate relationship between different Prakriti and Shukra sara Purush w.s.r to semen analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek N Acharya |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
B 134 Taksh Angan
Sayajipura
Ajwaroad
Vadodara
Parul University
Limda
Waghodiya
Vadodara
GUJARAT
390019
India |
| Phone |
9428844491 |
| Fax |
|
| Email |
agyainfertilitycentre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Nikhate |
| Designation |
Reader |
| Affiliation |
Parul Institute of Ayurved |
| Address |
A 30 Sanidhya township
Krishnapark street
behind dabhoi dashalad bhavan
Ajwa waghodiya ringroad
Vadodara
Parul University
Limda
Waghodiya
Vadodara
GUJARAT
390019
India |
| Phone |
9428844491 |
| Fax |
|
| Email |
dr.spnikhate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek N Acharya |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
B 134 Taksh Angan
Sayajipura
Ajwaroad
Vadodara
Parul University
Limda
Waghodiya
GUJARAT
390019
India |
| Phone |
9428844491 |
| Fax |
|
| Email |
agyainfertilitycentre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved
Limda
Tal Waghodiya
Dist Vadodara |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul University
Limda
Waghodiya |
| 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 Abhishek N Acharya |
Parul Institute of Ayurved |
Parul unoversity
limda
waghodiya
Vadodara
GUJARAT |
9428844491
agyainfertilitycentre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young male volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
Healthy males
Married males age between 25 years to 35 years |
|
| ExclusionCriteria |
| Details |
Individuals not living together with their sexual partner
Those receiving treatment for Pre Ejaculation or erectile dysfunction
Persons taking antidepressant therapy within 4 months of study
Drug abusers
Heavy smokers
Persons with major psychiatric illnesses
Patients suffering from heart disease Sexual transmitted diseases tuberculosis acute or chronic UTI or any organic defect in the penile region
Person who are suffering from any systemic disorder or any other major pathology |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kapha prakriti persons will have best sukra sarata than persons of vata and pitta prakriti |
5 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcome |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/02/2019 |
| 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
|
non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Healthy
male individuals will be selected randomly and will be assessed by prakriti
parikshana Out of that
Vata predominance 10
person Group A
Pitta predominance 10
person Group B
Kapha predominance 10
person Group C
Will be selected and there shukrasarata will
be assessed by Shukrasarata Proforma and the relationship of prakriti and
shukrasarata will be analyzed |