| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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,Pramehaâ€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 |