FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/04/051889 [Registered on: 24/04/2023] Trial Registered Prospectively
Last Modified On: 21/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   physiology of dhatu utpatti in Ayurveda in context to rasa dhatu & management of karshya(emaciation).  
Scientific Title of Study   A study on Physiology of Dhatu Utpatti in Ayurveda in context to Rasa Dhatu Utpatti and its role in manifestation and management of Karshya.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemang J Mehta  
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Department of Kriya Sharira 6th floor Institute of Teaching and Research in Ayurveda Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9427822504  
Fax    
Email  hemang.mehta2407@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Hitesh A Vyas 
Designation  Professor 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Room number 304 Department of Basic Principles 3rd floor Institute of Teaching and Research in Ayurveda Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9426433231  
Fax    
Email  vdhavyas@itra.edu.in  
 
Details of Contact Person
Public Query  
Name  Prof Hitesh A Vyas 
Designation  Professor 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Room number 304 Department of Basic Principles 3rd floor Institute of Teaching and Research in Ayurveda Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9426433231  
Fax    
Email  vdhavyas@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Opposite to Reliance Smart  
Type of Sponsor  Research institution and hospital 
 
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 Hemang J Mehta  ITRA Jamnagar  OPD no 18 Department of Kriya Sharira Institute of Teaching and Research in Ayurveda Jamnagar GUJARAT
Jamnagar
GUJARAT 		 9427822504

hemang.mehta2407@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 
Patients  (1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition, (2) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shunthi Ksheerapaka, Reference: yadavaji trikamji, Route: Oral, Dosage Form: Ksheerpaka, Dose: 45(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients having age between 18-50 years of irrespective of the genders.
2.Classical Signs and symptoms of Karshya. 3.B.M.I. Below 18.5 kg/m2.
4.Associated symptoms of malnutrition like dizziness, weight loss, muscle weakness. 5.Patients willing to give their consent to participate in the study. 
 
ExclusionCriteria 
Details  1.Age below 18 and above 50 years.
2.B.M.I. Above 18.5 kg/m2 will be excluded. 3.Patients suffering from chronic colitis, TB, Diabetes Mellitus, thyroid disease & any anatomical defect.
4.Due to drug induce & Karshya due to long term complications of any disease.
5.Patient not willing to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Shunthi Ksheera Paka in Karshya will be obtained.  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Explanation and understanding the concept of Prakritta Dhatu Utpatti in context of Rasa Dhatu Utpatti.  28 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3 
Date of First Enrollment (India)   28/05/2023 
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="0"
Days="28" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A STUDY ON PHYSIOLOGY OF DHATU UTPATTI IN AYURVEDA IN CONTEXT TO RASA DHATU UTPATTI AND ITS ROLE IN MANIFESTATION AND MANAGEMENT OF KARSHYA

INTRODUCTION: - Tridosha, Saptadhatu & Trimala form basis of body. Among these three, Dhatu has its own importance because Dosha express their functions by Dhatu through Ashrayaashrayi Bhava Acharya Sushruta describes Rakta originates from Rasa, then it (Rakta) produces Mamsa, which further produces Meda. Meda then produces Asthi, Asthi produces Majja and finally Shukra gets originated by Majja. Maharshi Charaka has said that each Dhatu is Ahara (diet) for next Dhatu for its origination, which also is the supportive statement of above mentioned physiology. Acharya Sushruta opines that a wise person should always prevent Rasa Dhatu because the entire body is made by Rasa. Acharya Sushruta mentioned Sthoulya and Karshya both happen due to Rasa. Acharya Charaka also included Krishangata in Rasapradoshaja Vikara. So for knowledge of pathogenesis of Karshya, cognition of Prakritta Dhatu Utpatti especially Rasa Dhatu Utpatti necessary. Understanding of the concept of Prakrita Dhatu Utpatti in context of Rasa Dhatu Utpatti will be achieved & Efficacy of Shunthi Ksheerapaka in Karshya will be obtained.
RATIONALITY FOR SELECTION OF TOPIC: - As per scholars information, no any study carried out to understand and explain the Ayurvedic concept of Dhatu Utpatti till date. Dhatus are one of the basic constituent of body which is having similar importance as of Dosha for maintaining health or illness. It is therefore important to understand the concept of Dhatu from its origination. This work is an effort in this direction. Rasa dhatu is only responsible for Anuloma Ksaya, so for proper Dhatu Nirman & for nourishment of all body, Rasa Dhatu is the only source. It is observed that many works carried out on Dhatu in general and few on Meda, Rakta, Asthi Dhatu but not a single work noted on Rasa Dhatu Utpatti. To demonstrate and validate the concept of Dhatu Utpatti, disease Karshya has been selected for applied study because it is closely related with the origination of Rasa Dhatu.
AIM: - To explore and explain the Ayurveda concept of Dhatu Utpatti in context of Rasa Dhatu Utpatti.
OBJETIVES: - To compile and analyze all the references regarding Prakritta Dhatu Utpatti from Brihattrayi, Laghutrayi & other ayurvedic texts. To explain functions of Rasa Dhatu. To evaluate the relation between Rasa Dhatu Utpatti & Karshya To prove efficacy of Shunthi Ksheerapaka in Karshya.
MATERIALS AND METHODS: - single group 30 patients between age group of 18 to 50 years. shunthi ksheerapaka given twice in a day to the karshya patients for 28 days.
RESULTS AND DISCUSSION: - data generated during the above study will be present in a systemic manner as shall be analysed statistically. where the important points of the conceptual study. analytical study, pharmacological study will be discussed.
 
Close