| CTRI Number |
CTRI/2025/02/080291 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of vegetarian and mixed diet on hemoglobin levels in healthy individuals |
|
Scientific Title of Study
|
An observational study of rakta sarata with special reference to hemoglobin level in healthy individuals consuming vegetarian and mixed diet |
| 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 Samarthkumar Subhash Fulari |
| Designation |
PG Scholar |
| Affiliation |
Bharati vidyapeeth Deemed to be university,college of ayurved ,pune |
| Address |
Bharati Vidyapeeth Deemed to be University College Of Ayurved Department of Kriya Sharir ,Katraj ,Dhanakawadi Campus ,Pune , Maharashtra -411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9960663735 |
| Fax |
|
| Email |
samarthkumar.fulari-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Kadam |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be university,college of ayurved,pune |
| Address |
Bharati Vidyapeeth Deemed to be University, College of Ayurved , Department of Kriya Sharir,Katraj , Dhanakawadi Campus ,Pune , Maharashtra -411043 ,India
Pune
MAHARASHTRA
411043
India |
| Phone |
8805503977 |
| Fax |
|
| Email |
manisha.kadam@bharatividyapeeth.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Kadam |
| Designation |
Assistant professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be university,college of ayurved,pune |
| Address |
Bharati Vidyapeeth Deemed to be University College of Ayurved, Department of Kriya Sharir, Katraj,Dhanakawadi Campus, Pune, Maharashtra -411043 ,India
Pune
MAHARASHTRA
411043
India |
| Phone |
8805503977 |
| Fax |
|
| Email |
manisha.kadam@bharatividyapeeth.edu.in |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University, College of Ayurved and Hospital, Department of Kriya Sharir, Katraj Dhanakawadi Campus, Pune, Maharashtra -411043, India |
|
|
Primary Sponsor
|
| Name |
Dr Fulari Samarthkumar Subhash |
| Address |
BHARTI VIDYAPEETH DEEMED TO BE UNIVERSITY OF AYURVED DEPARTMENT OF AYURVED DEPARTMENT OF KRIYA SHARIR ,KATRAJ DHANKAWADI,CAMPUS SATARA, PUNE ROAD, PUNE |
| 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 Samarthkumar Subhash Fulari |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital,Katraj Pune |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital, Department of Kriya Sharir, Katraj, Dhanakawadi Campus, Pune Maharashtra - 411043, India
Pune
MAHARASHTRA |
9960663735
samarthkumar.fulari-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Rakta Sara Vyakti will be selected according to AYUSOFT CDAC PERFORMA . Healthy individuals will be selected. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Healthy male individuals.
Rakta Sara male participants fulfilling the criteria of Rakta Sarata.
Age group of 17-30 will be taken |
|
| ExclusionCriteria |
| Details |
People with history of hematological disorder.
Individuals taking medications or supplements that could affect blood parameters |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study may reveal statistically significant differences in hemoglobin levels between the
two groups. Correlation between Rakta Sarata and hemoglobin level in vegetarian and mixed
diet consuming individuals will be established. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin will be seen of the vegetarian and mixed diet according to diet and results will be seen that diet can affect the hemoglobin |
1 day |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/02/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
etary assessment tools (questionary) will be prepared and validity, reliability will be cheked. As per the
inclusion criteria the participants will be selected
The study will be explained to the participants. Rakta Sarata Parikshan examination) of individual will he
assessed with the help of standard Sarata Parikshan Performa (AYUSOFT CDAC).
Individual will be assessed with the help of standard dietary questionary Healthy individuals will be
grouped into vegetarian and mixed diet (consuming both vegetarian and non-vegetarian diet).
By venipuncture method 1cc blood will be collected in EDTA tube and HB will be recorded using standard
method of testing of both group participants.
Correlation between Rakta Sarata and hemoglobin level in vegetarian and mixed diet consuming individual
will be studied |