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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
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.

 
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