| CTRI Number |
CTRI/2026/02/103114 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational and Analytical |
| Study Design |
Other |
|
Public Title of Study
|
Physical Activity & Diet On Rakta Dhatu Samhanan |
|
Scientific Title of Study
|
An Observational Study to Assess the effect of Physical activity & Diet on Samhanan of Rakta Dhatu (Sunivista Sonit)with special reference to different blood 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 Hitixa Patel |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda
Parul University Waghodia
Vadodara
GUJARAT
391760
India
Vadodara GUJARAT 391760 India |
| Phone |
9638406087 |
| Fax |
|
| Email |
hitupatel281296@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Narendra Yadnik |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda
Parul University Waghodia
Vadodara
GUJARAT
391760
India
Vadodara GUJARAT 391760 India |
| Phone |
9421655695 |
| Fax |
|
| Email |
narendra.yadnik26836@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Narendra Yadnik |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda
Parul University Waghodia
Vadodara
GUJARAT
391760
India
Vadodara GUJARAT 391760 India |
| Phone |
9421655695 |
| Fax |
|
| Email |
narendra.yadnik26836@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved and Parul Ayurveda Hospital,Vadodara,Gujrat,India,391760
|
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda
Parul University Limda Waghodia Vadodara GUJARAT 391760 |
| 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 Hitixa Patel |
Parul Institute Of Ayurved |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda Parul University Limda
Waghodia
Vadodara
GUJARAT Vadodara GUJARAT |
9638406087
hitupatel281296@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal ethics committee Parul Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy individuals aged 18 - 48 years grouped from different occupation
2)Who are ready to give consent for participation in study.
3)Free from acute or chronic systemic disease
4)Volunteers irrespective of Gender, Caste and Socio-economic status
5)Volunteers consuming Vegetarian or Mixed Diet
|
|
| ExclusionCriteria |
| Details |
1)Pregnant or lactating women.
2)Acute and Chronic diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in Rakta Dhatu Samhanana (Rakta Sarata score) between physically active and sedentary individuals |
At baseline (one-time assessment at enrollment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess variation in Rakta Dhatu Samhanana (Sunivishta Shonita) among individuals from different occupations & lifestyle patterns.
To compare Ayurvedic parameters of Rakta Sarata across different levels of physical activity (low, moderate, high).
To determine the association between dietary patterns & selected blood parameters (Hb%, hematocrit, plasma proteins, lipid profile, hydration status).
To explore the relationship between Rakta Sarata scores & modern hematological parameters.
To develop a preliminary integrated assessment framework for evaluating Sunivishta Shonita using Ayurvedic & modern parameters. |
At the time of recruitment single assessment |
|
|
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)
|
01/03/2026 |
| 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 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
|
This observational analytical study aims to evaluate the effect of physical activity and dietary patterns on the Samhanana of Rakta Dhatu (Sunivishta Shonita) with special reference to selected modern blood parameters. In Ayurveda, Samhanana denotes the compactness and integrity of body tissues, and Sunivishta Shonita represents well-formed, well-circulating, and well-nourished Rakta Dhatu, which plays a crucial role in maintaining strength, vitality, and nourishment of subsequent Dhatus. Although Samhanana is described in classical texts, its objective clinical assessment, particularly in relation to Rakta Dhatu, remains inadequately explored. A total of 60 apparently healthy volunteers aged 18–48 years will be recruited and categorized into two groups based on lifestyle: individuals with regular physical activity and individuals with sedentary habits. Physical activity will be assessed using MET scoring and the International Physical Activity Questionnaire (IPAQ-Long Form). Dietary patterns will be evaluated through a 24-hour food frequency questionnaire. Assessment of Rakta Dhatu Samhanana will be carried out using Ayurvedic parameters of Rakta Sarata along with modern hematological investigations such as complete blood count, hematocrit, plasma proteins, lipid profile, body temperature, and hydration status.The study is expected to establish correlations between physical activity, diet, Ayurvedic indicators of Rakta quality, and modern blood parameters, thereby contributing to the development of an integrated assessment approach for Sunivishta Shonita and strengthening the clinical applicability of the concept of Samhanana. |