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CTRI Number  CTRI/2024/12/078596 [Registered on: 26/12/2024] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An Observational Study To Assess The Prevalence of Madhumeha (Type 2 DM) In Sedentary Lifestyle. 
Scientific Title of Study   An Observational Study To Assess The Prevalence of Madhumeha (Type 2 DM) In Sedentary Lifestyle. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surbhi Jain 
Designation  PG Scholar 
Affiliation  Shri NPA Govt. Ayurveda College Raipur (Chhattisgarh) 
Address  Department of Kriya Sharira Shri Narayan Prasad Awasthi Government Ayurveda College Raipur (C.G.)

Raipur
CHHATTISGARH
492019
India 
Phone  8827358076  
Fax    
Email  surbhijain9777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Ashok Kumar 
Designation  Lecturer of Department of Kriya Sharira 
Affiliation  Shri NPA Govt. Ayurveda College Raipur (Chhattisgarh) 
Address  Department of Kriya Sharira Shri Narayan Prasad Awasthi Government Ayurveda College Raipur (C.G.)

Raipur
CHHATTISGARH
492010
India 
Phone  7999723405  
Fax    
Email  drashokbhagat044@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Surbhi Jain 
Designation  PG Scholar 
Affiliation  Shri NPA Govt. Ayurveda College Raipur (Chhattisgarh) 
Address  Department of Kriya Sharira Shri Narayan Prasad Awasthi Government Ayurveda College Raipur (C.G.)


CHHATTISGARH
492019
India 
Phone  8827358076  
Fax    
Email  surbhijain9777@gmail.com  
 
Source of Monetary or Material Support  
Department of Kriya Sharir Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India 
 
Primary Sponsor  
Name  DEPARTMENT OF KRIYA SHARIRA SHRI NPA GOVERNMENT AYURVEDA COLLEGE RAIPUR CHHATTISGARH 
Address  Department of Kriya Sharira Shri NPA Government Ayurveda College Raipur Chhattisgarh 492010 India 
Type of Sponsor  Other [Government Ayurved 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 
Surbhi Jain  Shri Khudadad Dungaji Government Ayurveda College and Hospital Raipur Chhattisgarh 492010  Speciality Clinic No 1 and 2 of Shri Khudadad Dungaji Government Ayurveda College and Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH 
8827358076

surbhijain9777@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:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients with age group of 30-60 years.
2 Patients diagnosed with Diabetes mellitus type-2, through WHO diagnostic criteria.
3 Selection of patients irrespective of sex, religion, socioeconomic status and marital status etc.
4 Patients who agree to sign consent form.
 
 
ExclusionCriteria 
Details  1 Patients age below 30 years and above 60 years.
2 Type-1 DM
3 Known cases of Immunocompromised state (AIDS), cancer, hepatitis myeloma.
4 Patient of any psychological disorders i.e. Psychosis, Alzheimer’s disease.
5 Pregnant and Lactating women.
6 Patients having any associated disease presenting with diabetes like symptoms (Urinary tract
disease, Renal disease)
7 Patients who do not agrees to sign consent form. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sedentary Lifestyle is a causative factor for Madhumeha (TYPE 2 DM).  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
There will be strong association between sedentary lifestyle & prevalence of Madhumeha TYPE 2 DM  1 Year 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   30/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Ayurveda, the ancient system of medicine that originated in India, is often referred to as the "science of life". Ayurveda has always emphasized to maintain the health and prevent the diseases by following proper diet and lifestyle regimen rather than treatment and cure of the diseases. The basic principle followed in the Ayurvedic system of medicine is Swasthyashya Swasthya Rakshanam, which means to maintain the health of the healthy. Ayurveda emphasizes the importance of balance in all aspects of existence, including physical activity.


In our fast-paced modern world, the sedentary lifestyle has become an increasingly prevalent concern, characterised by prolonged periods of physical inactivity and excessive sitting. According to Ayurvedic principles, a sedentary lifestyle disrupts the equilibrium of the body and mind, leading to the accumulation of toxins (ama) and the imbalance of bodily energies (doshas) – Vata, Pitta, and Kapha.


The nuanced understanding of Ayurveda reveals a profound connection between sedentary behavior and adverse health outcomes, as due to Asyasukham Swapnasukham kledadhikya, agnimandya, and tridoshdushti occurs. Kledadhikya or an excess of moisture within the body, emerges as a critical consequence of a sedentary lifestyle. This excess dampness is linked to agnimandya, a weakened digestive fire, which directly contributes to the imbalance of the three doshas (vata, pitta, and kapha) and disrupts the body’s natural equilibrium.


Prameha arises from the vitiation of various doshas and dushyas particularly Kapha and Meda (fat tissue). According to Acharya Charaka Prameha has 20 subtypes one of which is madhumeha. Madhumeha is a disease in which subject passes large quantity of urine with Kashaya, Madhura rasa and ruksha quality similar to the characteristics of honey and thus body attains sweetness. Pippalika- abhisharan is the characteristic feature of Madhumeha. It is also explained that, when the other Prameha are left untreated, this led to the condition called Madhumeha. So Madhumeha can also be considered as an advanced condition or stage of Prameha.


The World Health Organization (WHO) defines type 2 diabetes mellitus as a chronic metabolic disorder characterized by elevated blood glucose levels resulting from insulin resistance and relative insulin deficiency.


The early phase of Prameha (Pre-Diabetic condition) is considered manageable (sadhya). Highlighting the importance of early detection and lifestyle awareness in preventing severe diseases through nidanparivarjan.


The epidemiology of Type 2 Diabetes Mellitus (T2DM) in India presents a daunting public health challenge, with current estimates indicating that 77 million adults are living with the condition (2019), and an additional 25 million are categorized as prediabetic. Forecasts suggest a surge to over 134 million affected individuals by 2045.


The International Diabetes Federation estimates that 537 million people worldwide have diabetes as of 2021, with that number rising to 643 million in 2030 and 783 million in 2045.Type 2 diabetes, remains a significant contributor to global mortality, particularly due to its association with various complications such as cardiovascular disease, kidney disease, and stroke.


WHO issued a warning that a sedentary lifestyle may very well be one of the top 10 global causes of death and disability. Additionally, between 60 to 80 percent of people worldwide, in both developed and developing nations, lead sedentary lifestyles, making it one of the more severe yet under-addressed public health issues of our time.


Lifestyle modifications empower individuals to take an active role in managing their Diabetic condition, leading to better long-term outcomes and a higher quality of life.


Due to above mentioned points and to modify lifestyle timely for prevention of disease, I have chosen this topic as my research work.


 
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