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CTRI Number  CTRI/2025/11/097863 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 17/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Explaining the Function of Mitochondria for Understanding the Basis of Ayurvedic Prakriti 
Scientific Title of Study   Elucidating Mitochondrial Function by Profiling of Mito-nuclear Gene Variations towards Understanding the Molecular Basis of Ayurvedic Prakriti: A Determinant of Health and Longevity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Remya E 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Central Ayurveda Research Institute, Kalinga Studio Chowk, Bharatpur, Bhubaneswar, Odisha
Harinilayam, Elavana, Eranhikkal, elathur, Kozhikode - 673303, Kerala
Khordha
ORISSA
751029
India 
Phone  9447378133  
Fax    
Email  drremyaenair@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Remya E 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Central Ayurveda Research Institute, Kalinga Studio Chowk, Bharatpur, Bhubaneswar, Odisha
Harinilayam, Elavana, Eranhikkal, elathur, Kozhikode - 673303, Kerala

ORISSA
751029
India 
Phone  9447378133  
Fax    
Email  drremyaenair@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Remya E 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Central Ayurveda Research Institute, Kalinga Studio Chowk, Bharatpur, Bhubaneswar, Odisha
Harinilayam, Elavana, Eranhikkal, elathur, Kozhikode - 673303, Kerala

ORISSA
751029
India 
Phone  9447378133  
Fax    
Email  drremyaenair@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, 61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Remya E  Central Ayurveda Research institute , Bhubaneswar  Central Ayurveda Research institute , Near Kalinga Studio Chowk, Bharatpur, Bhubaneswar
Khordha
ORISSA 		 9447378133

drremyaenair@gmail.com 
Dr Subhash Singh  ICMR - Regional Medical Research Centre, Bhubaneswar  ICMR- Regional Medical Research Centre, Chandrasekharpur Bhubaneswar- 751023, Odisha, India
Khordha
ORISSA 		 9419125539

subhash0974@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  
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Apparently Healthy gender and age matched participants of age between 18-25 years of Prakriti subtypes.
2. Apparently healthy parents of participants who are willing to participate in the study providing a writtern consent
3. Participant native of the geographical zone.
 
 
ExclusionCriteria 
Details  1. Participants suffering from any acute or chronic disease condition.
2. Participant on any medication or health supplement.
3. Mentally challenged participants.
4. Not willing to provide written informed consent and participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SNP signatures of the mito-nuclear genetic components of the ETC complexes for the different Prakriti subtypes.   Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
1. Insight into the inheritance of the parental traits (SNPs) within the mito-nuclear genetic components of the ETC complexes in determining the Prakriti of the offspring.
2. Any co-relation with SNP signatures of the mito-nuclear genetic components of the ETC complexes with the Agni status of the study subjects.
3. Any co-relation with Prakriti subtypes of the study subjects with other clinical and biochemical parameters analyzed such as levels of stress, anxiety, blood plasma total antioxidant levels, and other blood plasma analytes.
 		 Baseline 
 
Target Sample Size   Total Sample Size="605"
Sample Size from India="605" 
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)   01/12/2025 
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="2"
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  


Upon approval from the Institutional Ethics Committee screening for healthy individuals, in the age agroup 18-25 will be done in the OPD of CARI, Bhubaneswar, extensive camps in various educational institutions in Bhubaneswar and various NGOs.The SRF and investigators will be engaged in the process of screening and prakriti assessment of the apparently healthy individuals.

 Gender and age matched 605 apparently healthy participants (participants and a subset of study participants’ biological parents of the participants which will be equally and randomly selected as per feasibility of the study) satisfying the inclusion criteria who will voluntarily give written informed consent for the study would be enrolled as volunteers for participating in this study. The participant will be screened for prakriti using CCRAS AYUR Prakriti assessment web portal. The swasthya assessment will be done using the CCRAS Swasthya Assessment tool. The Agni assessment of the enrolled participant will be done through Agni assessment tool developed by CCRAS. The participants will be subjected to further screening using laboratory investigations (at ICMR-RMRCBB). The participants found as having excellent health as per SAS will be enrolled in study.

 

Detailed demographic, personal including familial & habitual traits, and medical and treatment history of the participants will be recorded in a specific proforma developed incorporating Ayurveda details as well for the study.  The dietry recall of the participant will be done prior to sample collection. The perceived stress will be assessed using Perceived Stress Scale and anxiety level of participants will be assessed using the HAM-A scale and nutritional index measurement will be done  on the day of sample collection.

 


Briefly, 3-4 ml peripheral blood would be collected from the forearm using heparin containing vacutainer tubes. The blood samples will be transported to ICMR-RMRCBB haematological and biochemical evaluation. These blood samples will be used for biochemical analysis to determine the physiological health, and antioxidant of the study participant. Blood spots will be collected in FTA cards as per the SOP and the dried blood spots in FTA cards will be transported to ICMR-RMRCBB for genomic DNA isolation, as per standard procedures, for use in the sequencing of the mito-nuclear ETC exome. 

 
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