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CTRI Number  CTRI/2025/08/093757 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Correlational Study on Shleshma (Kapha) Nanatmaja Vikara in Patients with Hypothyroidism with special reference to Nidan Panchak 
Scientific Title of Study   A CORRELATIONAL STUDY TO ANALYSE SHLESHMA NANATMAJA VIKARA WITH HYPOTHYROIDISM AND TO STUDY NIDAN PANCHAK OF HYPOTHYROIDISM 
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 Komal 
Designation  PG Scholar 
Affiliation  Institute for Ayurved Studies & Research 
Address  Room number 98 Department of Rog Nidan Evum Vikriti Vigyan Institute for Ayurved Studies and Research Umri road Sector 8 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  07027935835  
Fax    
Email  drkomal35@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Randhir Singh 
Designation  Professor 
Affiliation  Institute for Ayurved Studies & Research 
Address  Room number 94 Department of Rog Nidan Evum Vikriti Vigyan Institute for Ayurved Studies and Research Umri road Sector 8 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  7015167849  
Fax    
Email  singhrandhir13476@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Komal 
Designation  PG Scholar 
Affiliation  Institute for Ayurved Studies & Research 
Address  Room number 98 Department of Rog Nidan Evum Vikriti Vigyan Institute for Ayurved Studies and Research Umri road Sector 8 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  07027935835  
Fax    
Email  drkomal35@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Institute for Ayurved Studies and Research Shri Krishna Ayush University 
Address  Sector 8 Umri road Kurukshetra 136118 
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 Komal  Institute for Ayurved Studies & Research  Room number 98 PG Department of Rog Nidan Evum Vikriti Vigyan Sector 8 Umri road Kurukshetra Haryana
Kurukshetra
HARYANA 		 07027935835

drkomal35@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Krishna Ayush University Kurukshetra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: NANATMAJA-SLESHMAVIKARAH, (2) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: NANATMAJA-SLESHMAVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Already diagnosed patients of Hypothyroidism in age group of 20-60 years will be selected .
2 Both sex will be included in the study.
3 Patients who are willing for consent be taken in the study. 
 
ExclusionCriteria 
Details  1 Patients age group of below 20 years and above 60 years will be excluded.
2 Patient not willing for consent.
3 Pregnant or lactating women.
4 Patients with chronic illness that can affect thyroid function or study parameters like chronic kidney disease (CKD) ,chronic liver disease ,
uncontrolled diabetes mellitus, cardiovascular disease  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will help to correlate Hypothyroidism with Shleshma Nanatmaja Vikara.
It will analyze the detailed Nidan-Panchak of Hypothyroidism on the basis of
Ayurvedic aspect.  		 10 to 15 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   05/09/2025 
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="6"
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   Hypothyroidism is a serious health issue worldwide. There are many researches done on treatment of Hypothyroidism. Hypothyroidism is a prevalent endocrine disorder affecting a large portion of the global population.  Its symptoms like weight gain, lethargy, cold intolerance, constipation closely resemble Shleshma Nanatmaja Vikara mentioned in Ayurvedic texts.By conducting a correlational study, this study will help bridge the gap between modern endocrinology and Ayurvedic pathology, providing a diagnostic and therapeutic approaches. • It will also provide foundation for the development of effective Ayurvedic treatment protocols for managing Hypothyroidism by using Shleshma Nanatmaja Vikara.   
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