| CTRI Number |
CTRI/2025/12/098449 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the causes of obesity and its link with body inflammation |
|
Scientific Title of Study
|
Evaluation of aetiopathogenesis and association of inflammatory markers in sthaulya-an observational clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranali chougule |
| Designation |
Pg Scholar |
| Affiliation |
Kahers Shri BM Kanakanwadi Ayurvedic Mahavidyalaya Shahapur Belagavi |
| Address |
Kahers Shri BM Kanakanwadi Ayurvedic Mahavidyalaya Shahapur Belagavi
Roganidana department
Belgaum
KARNATAKA
590003
India |
| Phone |
09028819550 |
| Fax |
|
| Email |
pranalichougule020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Keertan M S |
| Designation |
Professor |
| Affiliation |
Kahers Shri BM Kanakanwadi Ayurvedic Mahavidyalaya Shahapur Belagavi |
| Address |
Kahers Shri BM Kanakanwadi Ayurvedic Mahavidyalaya Shahapur Belagavi Department of Roganidana
Belgaum
KARNATAKA
590003
India |
| Phone |
9886238888 |
| Fax |
|
| Email |
keertanms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keertan M S |
| Designation |
Professor |
| Affiliation |
Kahers Shri BM Kanakanwadi Ayurvedic Mahavidyalaya Shahapur Belagavi |
| Address |
Kahers Shri BM Kanakanwadi Ayurvedic Mahavidyalaya Shahapur Belagavi Department of roganidana
Belgaum
KARNATAKA
590003
India |
| Phone |
9886238888 |
| Fax |
|
| Email |
keertanms@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pranali Chougule |
| Address |
Kahers Shri BM Kanakanwadi Ayurvedic Mahavidyalaya Shahapur Belagavi- 590003 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Pranali chougule |
Kahers Shri BM Kanakanwadi Ayurvedic Mahavidyalaya Shahapur Belagavi |
All OPD and IPD
OPD NO 3
Belgaum
KARNATAKA |
09028819550
pranalichougule020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee for Research on Human Subjects KAHERs Shri B M Kankanwadi Ayurveda Mahavidhyalaya and KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with either sex age group 18-50 years
Body Mass Index BMI more than 25 kg/m²
|
|
| ExclusionCriteria |
| Details |
Patient who are diagnosed to have systemic disorders like diagnosed with Uncontrolled Hypertension more than 140 by 90mmhg Thyroid disorders Malignancy patient Psychological disorders and any serious systemic illness
Pregnant and Lactating women
Major skin allergic conditions and diagnosed major skin diseases patients
Patient who are having a past history of Stroke MI severe Pulmonary Dysfunctions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of aetiopathogenesis and demonstrate an association between inflammatory markers in sthaulya |
30 Minutes to 1 Hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2026 |
| 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
|
Obesity and overweight occur due to excessive fat accumulation resulting from reduced energy expenditure, leading to adverse health outcomesThese chronic conditions significantly contribute to diseases such as Type 2 diabetes dyslipidemia hypertension and cardiovascular disorders According to WHO 2022 1 in 8 people globally are overweight or obese with over 2.5 billion adults affected and 890 million living with obesity Obesity involves the expansion of adipose tissue, which functions as an active endocrine and immune organ. It produces pro-inflammatory cytokines especially interleukin-6 IL 6and complement factors These cytokines stimulate hepatic synthesis of acute-phase proteins such as C reactive protein CRP leading to elevated circulating inflammatory markers From an Ayurvedic perspective, symptoms such as Gourava correlate with impaired circulation and inflammatory changes The concept of Ama representing toxic metabolic byproducts parallels the accumulation of inflammatory mediators in obesity Since Sthaulya is a major risk factor for cardiovascular diseases evaluating its aetiopathogenesis and correlating classical symptoms with inflammatory markers is essential
|