| CTRI Number |
CTRI/2025/03/082569 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Survey |
| Study Design |
Other |
|
Public Title of Study
|
To measure the vitality and health of the blood, which is essential for maintaining overall physical and mental well-being. |
|
Scientific Title of Study
|
A Study to Develop and Validate Assessment Criteria for Rakta Sara and its correlation with Haematological Parameters |
| 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 Sourav Khutela |
| Designation |
P G Scholar |
| Affiliation |
Institute for Ayurved Studies and Research, Shri Krishna Ayush University |
| Address |
Room no. 26, Kriya Sharir Department, Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Sector 8, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8930621972 |
| Fax |
|
| Email |
khutelasourav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Khatri |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved Studies and Research, Shri Krishna Ayush University |
| Address |
Room no. 10, Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Sector 8, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9416482897 |
| Fax |
|
| Email |
manikhatri79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourav Khutela |
| Designation |
P G Scholar |
| Affiliation |
Institute for Ayurved Studies and Research, Shri Krishna Ayush University |
| Address |
Room no. 26, Kriya Sharir Department, Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Umri road, Sector 8, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8930621972 |
| Fax |
|
| Email |
khutelasourav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research, SKAU, Umri road, Sector 8, Kurukshetra, Haryana, India, 136118 |
|
|
Primary Sponsor
|
| Name |
Dr Sourav Khutela |
| Address |
Institute for Ayurved Studies and Research, SKAU, Sector 8, umri road, Kurukshetra, Haryana, 136118 |
| 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 Sourav Khutela |
Institute for Ayurved Studies and Research |
Room no. 26, Department of Kriya Sharir
Kurukshetra
HARYANA |
8930621972
khutelasourav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Participants between the age group of 18 and 35 years.
Participants apparently healthy.
Willing to participate in study with consent.
|
|
| ExclusionCriteria |
| Details |
Individuals below the age of 18 years and above the age of 35 years.
Patient not willing to participate in the trial.
K/C/O Diabetes mellitus, hypertension, hyper or hypothyroidism, hemiplegia, epilepsy and any other chronic illness.
Pregnant women and Lactating mothers.
History of any Major surgery in the recent past.
History of Prolonged steroid medicine intake.
History of Alcohol intake & Smoking |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the level of Rakta sarata in Rakta Sara pradhan Purush assessing by validated Questionnaire. |
Screening, Baseline and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Use for Clinical work
Use for choosing occupation for job
Use to interpret progeny of disease. |
Screening, Baseline & 1 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2025 |
| 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
|
Questionnaire framing and development of tools for Rakta Sara will
be done. Then sent them for face validity and content validity. 60 research
participant will be selected from campus of Institute for Ayurved Studies
and Research, SKAU and other from Kurukshetra, check for inclusion and
exclusion criteria, duly signed and dated consent form by subject will be
taken. Assessment with the help of framed Questionnaire will be done. Data
will be collected then analysis and observation will be done . |