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CTRI Number  CTRI/2025/02/081279 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Observational Study on the Link Between Impaired Digestion (Agnimandya) and Rasa Dhatu Imbalance in Hypothyroidism 
Scientific Title of Study   An Observational Study on Assessment of Rasa Dhatu Dusti Lakshan with Agnimandya among Hypothyroidism Patients  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeti 
Designation  PhD Scholar  
Affiliation  Shri Krishna Ayush University Kurukshetra  
Address  Shri Krishna Ayurvedic college and Ayurvedic college and hospital Kurukshetra Haryana Dept of Kriya Sharir
Dept of Kriya Sharir Room number 23
Kurukshetra
HARYANA
136118
India 
Phone  9729839779  
Fax    
Email  Preetirathee1771@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Devendra Khurana 
Designation  Principal  
Affiliation  Shri Krishna Ayush University Kurukshetra  
Address  professor,Dept of Kriya Sharir Shri Krishna Ayush University Kurukshetra Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9416337325  
Fax    
Email  dr.devendrakhurana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Preeti 
Designation  PhD Scholar  
Affiliation  Shri Krishna Ayush University Kurukshetra  
Address  Shri Krishna Ayurvedic college and hospital Kurukshetra Dept of kriya sharir.
Department of Kriya sharir Room number 23
Kurukshetra
HARYANA
136118
India 
Phone  9729839779  
Fax    
Email  Preetirathee1771@gmail.com  
 
Source of Monetary or Material Support  
Shri Baba Mastanath Ayurvedic college and hospital Asthal Bohr Rohtak ,Haryana India 124001 
 
Primary Sponsor  
Name  Shri Krishna Ayurvedic college and Hospital 
Address  Kurukshetra ,Haryana 136118 
Type of Sponsor  Research institution 
 
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 Preeti  Shri Baba Mastnath Ayurvedic College and Hospital,Asthal Bohr Rohtak   Asthal Bohr, Rohtak, Haryana,Ayurveda Department Dept of kayachikitsa OPD number 23
Rohtak
HARYANA 		 95604 59148

Preetirathee1771@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central ethical committee on human research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: RASAVAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient of age 18-60 yr, having high level of TSH(Hypothyroidism) 
 
ExclusionCriteria 
Details  Patients having age below 18years and above 60 years
All complicated cases of Hypothyroidism, myxedema, severe mental illness, thyroid cancer etc and other disease associated with endocrine imbalance.
Patients having chronic systemic illness. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Their should be a positive correlation between rasa dhatu dusti lakshana and hypothyroidism   Since this is an observational cross-sectional study, the primary outcome will be assessed at a single time point during the patients evaluation.
Baseline Assessment (Day 0):

Clinical evaluation of Rasa Dhatu Dusti Lakshanas using Ayurvedic diagnostic parameters.
Assessment of Agnimandya through clinical symptoms (such as appetite, digestion, bloating, and bowel habits).
Collection of biochemical markers (e.g., TSH, T3, T4 levels) 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of Specific Rasa Dhatu Dusti Symptoms:

Understanding which particular signs & symptoms of Rasa Dhatu Dusti are most prevalent among hypothyroid patients.
Variations in Agnimandya Among Different Individuals:

Assessing the degree of digestive impairment (Agnimandya) in different subsets of hypothyroid patients
Impact of Chronicity on Ayurvedic Parameters:

Evaluating whether the duration & severity of hypothyroidism influence the degree of Rasa Dhatu Dushti & Agnimandya. 		 Baseline (Day 0 / Initial Consultation):

Assessment of Rasa Dhatu Dusti Lakshanas (symptoms such as dryness, lethargy, weakness, & impaired metabolism).
Evaluation of Agnimandya (digestive function, appetite, bloating, constipation, etc.).
Thyroid function tests (TSH, T3, T4) as a reference point.
BMI, weight, & other general health parameters. 
Their should be high BMI in hypothyroidism patient  Their should be high BMI in hypothyroidism patients  
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   07/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
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  

Background:

Hypothyroidism is a common endocrine disorder characterized by reduced thyroid hormone levels, leading to metabolic dysfunction. Ayurveda correlates hypothyroidism with Rasa Dhatu Dusti (vitiation of the Rasa Dhatu) and Agnimandya (digestive impairment), which contribute to symptoms such as fatigue, weight gain, and sluggish metabolism. This study aims to assess the relationship between Rasa Dhatu Dusti symptoms and Agnimandya in hypothyroid patients from an Ayurvedic perspective.

Objectives:

  1. To evaluate the presence of Rasa Dhatu Dusti Lakshanas (clinical signs of Rasa Dhatu imbalance) in hypothyroid patients.
  2. To assess the correlation between Agnimandya (weakened digestion) and Rasa Dhatu Dushti in these patients.
  3. To explore the Ayurvedic pathophysiology of hypothyroidism.

Methodology:

  • Study Design: Observational cross-sectional study.
  • Sample Size: A selected group of diagnosed hypothyroid patients.
  • Inclusion Criteria: Patients with clinically diagnosed hypothyroidism.
  • Assessment Tools: Ayurvedic parameters of Rasa Dhatu Dusti and Agnimandya, along with clinical symptoms and relevant biochemical markers.
  • Data Analysis: Statistical evaluation of the correlation between Rasa Dhatu Dusti symptoms and digestive function (Agnimandya).

Expected Outcome:

The study aims to establish a link between Rasa Dhatu Dusti and Agnimandya in hypothyroidism, contributing to a better understanding of its Ayurvedic pathophysiology. The findings may help in developing integrative approaches for the management of hypothyroidism through Ayurveda.

 
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