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CTRI Number  CTRI/2025/03/081907 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 07/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study to evaluate the quality of body tissues in peoples of different ages. 
Scientific Title of Study   Estimation of Dhatusaara in Different Age Groups An Analytical Cross-Sectional Study 
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 Sudhir Kumar 
Designation  Assosiate Professor 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Institute block,3rd Floor, Room No. 322,Department of Rachana Sharir,Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, South west New Delhi 110073

South West
DELHI
110073
India 
Phone  9718287772  
Fax    
Email  drsudhir66@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Piyush Kumar Verma 
Designation  PG Scholar 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Institute block,3rd Floor, Tutorial Room,Department of Rachana Sharir,Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, South west New Delhi 110073

South West
DELHI
110073
India 
Phone  08510810913  
Fax    
Email  piyushverma.vp159@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Piyush Kumar Verma 
Designation  PG Scholar 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Institute block,3rd Floor, Tutorial Room,Department of Rachana Sharir,Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, South west New Delhi 110073

South West
DELHI
110073
India 
Phone  08510810913  
Fax    
Email  piyushverma.vp159@gmail.com  
 
Source of Monetary or Material Support  
Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, South west New Delhi 110073 
 
Primary Sponsor  
Name  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh South West New Delhi 110073 
Type of Sponsor  Government 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 Piyush Kumar Verma  Ch. Brahm Prakash Ayurved Charak Sansthan  OPD/IPD Hospital Block,Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, South west New Delhi 110073
South West
DELHI 
08510810913

piyushverma.vp159@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ch. Brahm Prakash Ayurved Charak Sansthan Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Apparently healthy individuals of the age groups irrespective of gender. 
 
ExclusionCriteria 
Details  Person suffering from any acute or chronic illness.
Pregnant woman.
Any congenital or acquired anomaly,
Person having any kind of co-morbidity like T2DM, HTN, THYROID DYSFUNCTION, CVD etc.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Result is expected to show Variability of Dhatusara of an individual with progression of age. It is expected that sara of dhatus will decrease progressively as mentioned in Ayurvedic texts. Thereby it will further help in establishment of the principle of dhatu/dhatusara in Rachana Sharir.  1 day 
 
Secondary Outcome  
Outcome  TimePoints 
Result is also expected to show the proportion of variability of dhatusara with age. This will be further addition in the knowledge of dhatusara.  2 days 
 
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)   20/03/2025 
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  

INTRODUCTION

 

Ayurveda is one of the oldest sciences (6000 BCE) of the world which discuss about the concept of dhatu along with the core concepts of tridosha, panchmahabhootha, prakriti etc. It tells that the  physical constitution of any living creature is formed by dhatus. There are seven dhatus, namely rasa, rakta, mamsa, medas, asthi, majja, shukra performing specific functions.

Acharya Charak stated, “bala mana vishesh gyaanartham updishyate,” which means that dhatu sara assesses an individual’s level of strength. The purest form of dhatus, sara, must be in its ideal state (Prakrit avastha) and not influenced by any dosha in order to exhibit these traits. When dhatvagni and bhutagni are in their optimum state, the formation of sama dhatus takes place and when these dhatus are in their excellent state, it is called sara of that particular dhatu.

Dhatusara is the essence of dhatus (visudhataro dhatu) which signifies the ultimate quality of dhatu and excellent functional aspect. Dhatusara has been mentioned for the assessment of strength (Bala) and life span of patient. Individuals on the basis of dhatusara have been classified  into various categories depending upon the predominance of a particular dhatu in the body, except  the Satva saara which is based on the predominance of satva (psychic factor). In the body, eight saara have been described in texts of Ayurveda.

According to Acharya Charak, age is broadly divided into three stages viz. Baalya Avastha, Madhyam Avastha & Jeerna avastha.

Baalya avastha is determined up to the age of 16 years when dhatu are immature(बालमपरिपक्वधातुम), sexual characters are not manifested the body is delicate, unenduring with incomplete strength and predominance of Kapha. From 16-30 years all dhatu are in developing state(विवर्धमानधातुगुण).

Madhyam avastha(30-60 years) is characterized by strength, energy, virility, valor, acquisition, retention, recollection, speech, understanding and qualities of all dhatu having developed properly(सर्वधातुगुण); with proper physical and mental strength, without degeneration in qualities of dhatu, with predominance of Pitta  and is up to 60 years.

Jeerna avastha (60-100 years), during this period dhatu, sense organs, strength, energy, virility, prowess, acquisition, retention, recollection, speech and understanding generally or gradually degenerate (भ्रश्यमानधातुगुण), this phase is predominated by Vayu. During this stage the measure of life span is one hundred years.

Keeping the above facts in mind, present study entitled “Estimation of Dhatusaara In Different Age Groups â€“ An Analytical Cross-Sectional Study” has been designed to assess the dhatusaara of the healthy individuals in different age groups.

Lacunae in existing knowledge

 

There are several studies regarding Dhatus and Dhatu Sarata separately. There is no available literature which tells direct relationship of Dhatu Sarata with Vaya.

 

   Previous Study done

1) Jagruti Chaple . Ayurvedic aspect of Dhatu Sarata and its Application Int J Ayu Pharm Chem 2018 Vol. 9 Issue 2[e ISSN 2350-0204]

2) Pragya Sharma, Mahesh Vyas, Bhojani Meera K et al. Signifcance of Sara Pariksha in Ayurveda: A Critical review. Research and Reviews:A Journal of Ayurvedic science,Yoga and Naturopathy;5(3):1-6p.

3) Review Article Clinical Significance and Research-oriented Approach of Dhatu Sarata (Tissue Excellence)- by Dr.Ridhima Gupta, Dr. Manjry Anshumala Barla, Dr. Rakesh Roushan-Dept of Kriya Sharir- Journal of Advanced Research in Ayurveda, Yoga, Unani, Sidhha & Homeopathy (ISSN: 2394-6547)

4) Review Article STUDY OF DHATU SARATA AND ITS SIGNIFICANCE IN CAREER ASSISTANCE- by Dr. Prachi Upesh Likhar and Dr. Upesh Madhukar Likhar-Dept of Kriya Sharir- World Journal of Pharmaceutical Research(ISSN 2277– 7105).

5) Review Article A CRITICAL REVIEW ON CONCEPT OF SARA IN AYURVEDA- by Dr.Vinita Dhruw,Dr. Gitanjali Sasmal and Dr.Vinay Bhardwaj-Dept of Kriya Sharir- World Journal of Pharmaceutical Research(ISSN 2277– 7105).

 

Research question

 

Whether there is a variability in dhatusaara of individuals in different age groups?

 

 

Hypothesis

 

There is an effect of vaya (age) on dhatusaara of the individuals.

 

Aim

· ESTIMATION OF DHATUSARA IN DIFFERENT  AGE GROUPS.

Objectives

 

· To estimate the dhatusara of the individual in three different age groups (preferably bala vaya, Madhya vaya and vridha vaya) over the entire duration of research.

Review of literature

 

Sara provides information about the condition of different dhatus in Sharira and also gives an idea of status of Satva (mind) of an individual. Sara is defined as the excellency of Dhatu. Among the fundamental constituent of body, the Dhatus are very important, which performs the functions of Dharana (Structural framework) and Poshana (Nutritional pool)

Assessment for a Dhatu and its structural and functional state by virtue of its quality and functions can be done by Sara Pareeksha. By the described of Chakrapaani it is clear that characteristics of Sara is an index to measure the Bala of individual Dhatu.[4]

Derivation - The term “Sara” is derived from the root Sr. Sthire with Suffix Ghan meaning essential, most excellent, stable, true, strong, genuine, and vigorous. Three meanings are taken from the word sara force, steady and ultimate.

According to Chakrapani’s Sara concept is related to the Dhatu concept. Each individual consists of seven Dhatus (elementary tissue) in homeostasis state. The body, which is consists of seven Dhatu in several quantum, differs from one another at the extents of Dhatu Sarata. Based on that Sara mainly classified as Pravara, Avara and Madhyama. Among all those eight, Sattva Sara denotes longer life and prosperity than the Twaka Sara. Sushruta Samhita also emphasized that a physician can treat a patient more effectively, if he assesses the life expectancy of patient on the basis of the criteria of measurement of each body part and Sara Pariksha.

Charaka Samhita- Twak Sara, Rakta Sara, Mamsa Sara, Meda Sara, Asthi Sara, Majja Sara, Shukra Sara, Sattva Sara.

Sushruta Samhita- Twak Sara, Rakta Sara, Mamsa Sara, Meda Sara, Asthi Sara, Majja Sara, Shukra Sara, Sattva Sara.

Astanga Samgraha- Twak Sara, Rakta Sara, Mamsa Sara, Meda Sara, Asthi Sara, Majja Sara, Shukra Sara, Sattva Sara.

Astanga Hridaya- Twak Sara, Rakta Sara, Mamsa Sara, Meda Sara, Asthi Sara, Majja Sara, Shukra Sara, Sattva Sara.

Kashyapa Samhita- Twak Sara, Rakta Sara, Mamsa Sara, Meda Sara, Asthi Sara, Majja Sara, Shukra Sara, Ojas Sara, Sattva Sara.

SarvaSara/Pravara Sara Purusha-These persons having all eight sara will have great physical and mental strength, more happiness, able to face difficulties, self confidence in all enterprises, virtuous act, having firm and balanced body with balanced movements which is very careful and proper. There will be smooth and of high pitch, good to listen booming voice, slowness of aging and pathogenic process. Mostly having similar and numerous offspring and they will be having a longevity of life in family.

Madhyama Sara Purusa- Moderate amount of assorted Sara possess qualities with respectively Sara in moderate degree and which shows characteristic of Sarva Sara moderately.

Asara/Avara Sara Purusa- Features of Asara are not mentioned in compendia, hence we have to know features of Asara purusha logically or using Yukti Pramana. These persons, having slightest of various Sara, opposite qualities of respective Saras in minimum degree or least characteristics of Sarva Sara. They can’t withstand prolonged physiological activity. That’s why Sarva Sara individual has relatively higher resistance as compared to another Sara in an individual. The person having all the Sara, but predominating in one will possess more resistance against the various diseases which can arise because of its absence.

 Hence, all the subtypes of eight Sara must be examined as Sarva, Madhyama and Avara Sara by routine assessment in clinical examinations.

Acharya Charak has emphasized that sometimes, the physicians may take a wrong decision only by seeing the body of the patient like strong due to being corpulent, weak because of leanness, and very weak because of having small body. However, rationally, it’s observed that, the strength of any persons can’t be estimated by looking at the external structure of the body. It’s completely untrue to believe that an individual is of a huge body, then he will be strong and if he is poor, then he will be weak. They are like ants that have small body and appearance emaciated but can carry heavy load. Big and corpulent persons may have less strength than the lean and short body, like elephant having big and strong body possessing less strength that the lean and short bodies lion.

Individuals having the excellence of rasa are characterized by Unctuous, smooth, soft, clear, fine, less numerous, deep rooted, and tender hair and lustrous skin.

Individuals having the excellence of rakta are characterized by unctuous and coppery red nails, eyes, palate, tongue, nose, lips, sole of the hands and feet, nails, forehead, and genital organs.

Individuals having the excellence of mamsa are characterized by Stability, heaviness, beautiful appearance and plumpness of temples, forehead, nape, eyes, cheeks, jaws, neck, shoulder, abdomen, axillae, chest, and joints of upper and lower limbs being covered with flesh.

Individuals having the excellence of meda are characterized by Abundance of unctuousness in complexion, voice, eyes, hair of the head and other parts of the body, nail, teeth, lips, urine, and feces.

Individuals having the excellence of asthi are characterized by Robust heels, ankles, knees, fore- arms, collarbones, chin, head, joints, bones, nails, and teeth.

Individuals having the excellence of majja are characterized by Softness of organs, strength, unctuous complexion, and voice and robust long and rounded joints.

Individuals having the excellence of sukra are characterized by Gentleness, gentle look, having eyes as if filled with milk, cheerfulness, having teeth which are unctuous, round, strong, even and beautiful, clean and unctuous complexion and voice, dazzling appearance and large buttocks.

The sattva sara persons are endowed with memory, devotion , are grateful , knowledgeable, cleanliness , enthusiastic, skillful, courageous, fighting in battle with valor, free from anxiety, having well-organized activities and highly intellectual abilities engaged in virtuous act.

 Different Factors affecting Dhatu Sarata Dhatu Sarata in different Vaya (Age Group) :

Children (balya awastha) generally have less dhatu sara since their dhatus are in the developing stage (Aparipakwa, Asampoorena Dhatutwam). Due to ksheena dhatus, vriddha exhibit less dhatu sarata whereas, madhyam ayu purusha (middle age) possesses the best sara due to uttam bala.

Materials and methods

 

Study population: Apparently 150 healthy study participants irrespective of gender will be included in the study (50 for each group).

Calculation of sample size is done in accordance with an observational study of healthy subjects. Daniel’s formula calculation gave a sample size of 384 which is maximum sample size for an observational study. As our study is having a limited time period and elaborative performa for dhatusara estimation, it is not possible to enroll 384 subjects. Hence, sample size of 100 was proposed in IRC which was later on increased to 150 by IRC.

 

Study plan: Dhatusaara will be determined by the dhatusaara assessment module of ayusoft developed by CDAC.

Study period: 1 year

 

Study design: Analytical cross-sectional study (observational study)

 

Statistical method: Descriptive Statistics will be applied.

Mean and Standard Deviation of all three groups will be reported considering the data is normal. If data is appeared to be skewed then Kolmogorov–Smirnov test will be applied to test the normality. If data is confirmed skewed then Median and Ranger will be reported.

 

Study location: Subjects from CBPACS, Khera Dabar and nearby areas.

 

Inclusion criteria

 

Apparently healthy individuals of the age groups irrespective of gender:

 

Baalya Avastha : 18-30 years

Madhyam Avastha : 30-60 years

Jeerna Avastha : >60 years

 

 

Exclusion criteria

 

Person suffering from any acute or chronic illness.

Pregnant woman.

Any congenital or acquired anomaly,

Person having any kind of co-morbidity like T2DM, HTN, THYROID DYSFUNCTION, CVD etc.

 

Expected Outcome

 

The result will be a data backed presentation of qualitative and quantitative changes in Sara of dhatus with progression of age.

 

1. Result is expected to show â€œVariability of Dhatusara” of an individual with progression of age. It is expected that sara of dhatus will decrease progressively as mentioned in Ayurvedic texts. Thereby it will further help in establishment of the principle of dhatu/dhatusara in Rachana Sharir.

2. Result is also expected to show the “proportion of variability” of dhatusara with age. This will be further addition in the knowledge of dhatusara.

 
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