| CTRI Number |
CTRI/2024/11/077372 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find relation between quality of Rasadhatu and Greying of hair that is Palitya.
|
|
Scientific Title of Study
|
A cross sectional analytical study to find relation between Rasasarata and Palitya in 18-30 age group 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 Bhagyesh Dadasaheb Kare |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
Ground Floor Kriya Sharir Deprtment PDEAs College of Ayurved and Research Centre Sector No 25 Pradhikaran Nigdi Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9860444485 |
| Fax |
|
| Email |
drbhagyesh12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Chobhe |
| Designation |
HOD and Guide |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
Ground Floor Kriya Sharir Department PDEAs College of Ayurved and Research Centre Sector No 25 Pradhikaran Nigdi Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9850716124 |
| Fax |
|
| Email |
swatichobhe@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyesh Dadasaheb Kare |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
Ground Floor Kriya Sharir Department PDEAs College of Ayurved and Research Centre Sector No 25 Pradhikaran Nigdi Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9860444485 |
| Fax |
|
| Email |
drbhagyesh12@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
Dr Bhagyesh Dadasaheb Kare |
| Address |
PDEAs College of Ayurved and Research Centre Sector No 25 Pradhikaran Nigdi Pune 411044 |
| 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 |
| Dr Bhagyesh Dadasaheb Kare |
PDEAs College of Ayurved and Research Centre Nigdi Pune 411044 |
Kriya Sharir Department PDEAs College of Ayurved and Research Centre Sector No 25 Nigdi Pune 411044
Pune
MAHARASHTRA |
9860444485
drbhagyesh12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of College of Ayurved and Research Centre Nigdi Pune 44 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals between age group 18 to 30 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals with symptoms of Palitya in Group A
2.Individuals not having symptoms of Palitya in Group B |
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Any chronic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess relation between Rasasarata and Palitya when compared with non Palitya with the help of Grey hair scale |
One Time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Rasadushti Lakshanas in Palitya & non Palitya individuals with the help of questionnaire. |
One Time |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
05/12/2024 |
| 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="0"
Months="6"
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
|
This is a cross sectional analytical study to find relation between Rasasarata and Palitya when compared with non Palitya in 18-30 age group individuals .This study also assess Rasadushti Lakshanas in both groups. Assessment of Rasadhatu will certainly help in clinical practice in focus of balancing of Rasadhatu in prevention of Palitya. |