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CTRI Number  CTRI/2024/07/069776 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 29/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Know the Efficacy of Truptighna Mahakashaya in Insulin Resistance In Obesity 
Scientific Title of Study   CONCEPT OF TRUPTI AND EVALUATION OF THE EFFICACY OF TRUPTIGHNA MAHAKASHAYA IN SANTRAPANAJANYA STHOULYA VIS-A-VIS INSULIN RESISTANCE IN OBESITY  
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 Shreekantha D Dodmani 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital, mysore 
Address  OPD No 10 Government Ayurveda Medical College and Hospital Visvesvaraya Circle Devaraja Mohalla Mandi Mohalla Mysore

Mysore
KARNATAKA
570001
India 
Phone  8660204601  
Fax    
Email  dodmanishreekanth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vasudev Anandarao Chate 
Designation  Professor Department of PG Studies Ayurveda Samhita and Siddhanta 
Affiliation  Government Ayurveda Medical College and Hospital, Mysore 
Address  OPD No 10 Government Ayurveda Medical College and Hospital Visvesvaraya Circle Devaraja Mohalla Mandi Mohalla Mysore

Mysore
KARNATAKA
570001
India 
Phone  9448150212  
Fax    
Email  vachate37@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreekantha D Dodmani 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  OPD No 10 Government Ayurveda Medical College and Hospital Visvesvaraya Circle Devaraja Mohalla Mandi Mohalla Mysore

Mysore
KARNATAKA
570001
India 
Phone  8660204601  
Fax    
Email  dodmanishreekanth@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital Mysore Karnataka India 57001  
 
Primary Sponsor  
Name  Dr Shreekantha D Dodmani 
Address  Government Ayurveda Medical College and Hospital Mysore 
Type of Sponsor  Other [Self] 
 
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 Shreekantha D Dodmani   Government Ayurveda Medical College and Hospital Mysore  OPD Room NO 10 Government Ayurveda Medical College and Hospital Mysore
Mysore
KARNATAKA 
8660204601

dodmanishreekanth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Government Ayurveda Medical College and Hospital Mysore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Truptighna Mahakashaya, Reference: Charaka Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Men Waist Circumference 85cm Waist Hip Ratio(WHR) 0.90
Women Waist Circumference80cm Waist Hip Ratio 0.80
BMI (Kg/m2) 25.1 -35
Fasting blood glucose 100-120 mg/dl
Fasting insulin serum 25-40 µU/mL
 
 
ExclusionCriteria 
Details  Patients of insulin dependent Diabetes mellitus
Pregnant and Lactating women
Patients with any other systemic ailments which interferes with the study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the Efficacy of Truptighna Mahakashaya in Santarpanajanya Sthoulya vis-a-vis Insulin Resistance in Obesity

Efficacy of Truptighna Mahakashaya will Evaluate Through Fasting Insulin Serum Test and Fasting Blood Glucose  
To evaluate the Efficacy of Truptighna Mahakashaya in Santarpanajanya Sthoulya vis-a-vis Insulin Resistance in Obesity which is to be Assessed on baseline and after intervention 7th week with Fasting Blood Glucose and Fasting Insulin Serum 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the Efficacy of Truptighna Mahakashaya Insulin Resistance in Obesity   To evaluate the Efficacy of Truptighna Mahakashaya in Insulin Resistance in Obesity
that is to be assessed on baseline & after intervention 7th week for fasting insulin serum & fasting blood glucose  
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   10/07/2024 
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="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  

India is experiencing a rapid health transition with a rising burden of Non-Communicable Diseases (NCD’s) / Life style related disorders (LRD’s) surpassing the burden of communicable or Infectious diseases  Nearly 5.8 million  people (WHO report, 2015) die from NCDS (heart and lung diseases  stroke cancer and diabetes) every year & 1 in 4 Indians has a risk of dying from an NCD before they reach the age of 70 year According to the WHO obesity is a major risk factor for non-communicable diseases such as heart disease, stroke  type 2 diabetes certain cancers and osteoarthritis

The worldwide prevalence of obesity is reaching pandemic proportions The WHO had estimated that in 2016 more than 1.9 billion adults worldwide (39%) were overweight, and over 650 million (13%) were obese  India—has one of the fastest growing obesity rates in the world  It is estimated that there are 135 million obese individuals in India It is very significant to note that in the development of other LRD’s associated with obesity insulin resistance is the intermittent phase of the progressive pathology from obesity to DM and so on

Obesity is not new to Indian knowledge system  Medical works of ancient India like the Bhruhatrayi’s and Laghutrayi’s have documented the diseases of lifestyle origin which are mainly categorized into Santarpanotta vikaras Obesity (sthoulya) is one of the primary symptom as well as a disease of sedentary lifestyle and wrong/ over eating habits (santarpana or atisantarpana  The causes pathophysiology symptomatology lifestyle modification recommendations  treatments for santarpanotta vikara’s are abundantly found in various chapters and sections of most of the classical Ayurveda works  This area in Ayurveda possesses a great strength and seems to be very much applicable in current health challenge with the rapid explosion of the incidences of LRD’s

‘Trupti’ technically “bhakshanaadina akamksha nivrutti”  which means the cessation of the desire for consuming food  it is satiety obtained after having enough quantity of eatables or drinkables  It is the sign of indication to stop consuming the food further  If a person indulge in the consumption of food ignoring the sign of satiety leads to over eating if this practice continued for longer time  habitually  may lead to digestive disturbance which further leads to metabolic derangement and may cause the diseases like “Sthoulya,Prameha”etc

Insulin resistance in obesity is a major concern among middle aged adults in India  It is a state of intermediate metabolic disturbance, which may further lead to Diabetes mellitus. In this condition the body secrets the insulin but tissues are unable to use it due to the loss of sensation of the cells to the molecules of the insulin  As a result of this it causes increase of insulin and glucose in the plasma of blood

 The current study intends to understand the concept of Trutpi w s r to the disease Sthoulya and breaking the progressive pathology of obesity leading to many metabolic impairment including hyperglycemia through the administration of Truptighna Mahakashaya in insulin resistance in obesity

 
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