| CTRI Number |
CTRI/2020/12/029588 [Registered on: 04/12/2020] Trial Registered Prospectively |
| Last Modified On: |
03/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Series Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to understand the difference between healthy and unhealthy obesity based on principles of Ayurveda |
|
Scientific Title of Study
|
Bio-Chemical changes in Individuals of High BMI with special referance to Medho Sara(excellence of adipose tissue) and Staulys (obesity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01217006 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumith Kumar M |
| Designation |
Assistant Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Dept of Basic Principles
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur, Belgaum
Karnataka, India
590003
Flat No 204
Shivaleela Residency
Savgaon Road, Nanawadi
Belgaum, karnataka, India
590006
Belgaum
KARNATAKA
590003
India |
| Phone |
9995635703 |
| Fax |
|
| Email |
sumithkumar.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B S Prasad |
| Designation |
Principal & Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur, Belgaum
Karnataka, India
590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9995635703 |
| Fax |
|
| Email |
bmkprincipal.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumith Kumar M |
| Designation |
Assistant Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Dept of Basic Principles
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur, Belgaum
Karnataka, India
590003
Flat No 204
Shivaleela Residency
Savgaon Road, Nanawadi
Belgaum, karnataka, India
590006
Belgaum
KARNATAKA
590003
India |
| Phone |
9995635703 |
| Fax |
|
| Email |
sumithkumar.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belgaum, karnataka, India - 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Sumith kumar m |
| Address |
Dept of Basic Principles
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belgaum, karnatala - 590003 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr B S Prasad |
Principal
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belgaum, Karnataka, India - 590003 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumith Kumar M |
KLE AYURVEDA HOSPITAL & MEDICAL RESEARCH CENTRE |
Utsaha OPD,KLE AYURVEDA HOSPITAL & MEDICAL RESEARCH CENTRE, Shahapur, Belgaum
Belgaum
KARNATAKA |
9995635703
sumithkumar.kaher@kleayurworld.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER PhD Ethical Committee(Human), Belgaum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
obesity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)BMI ≥ 25 kg/m2, 2)No history of major illness, 3)Not taking any kind of medication which affect the weight (paroxetine, valproic acid, Fluoxetine, mirtazapine, olanzapine, prednisone, chlorpromazine, amitriptyline, fexofenadine and pseudoephedrine, chlorpropamide, Insulin, atenolol, Birth-control pills, levotyroxin. 4) The volunteer should be willing to abide by trial procedures and give written informed consent
|
|
| ExclusionCriteria |
| Details |
1) Individuals suffering from any infectious disease, 2) Individuals taking weight gain supplements, 3) Individuals undergoing elective surgeries (abdominoplasty), 4) Individuals suffering from psychological disorders, 5) Non ambulatory
vi. Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Medho Sara and Sthaulya parameters in individuals of high BMI |
1 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study the Biochemical changes in Medho Sara and Sthaulya individuals |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="305"
Sample Size from India="305"
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)
|
15/12/2020 |
| 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
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Medho sara and Sthaulya individuals can possess a big body frame (Bruhat Shareera), wherein the Medho sara is physiology entity and Sthulya is pathological, but due to lack of clear identification of difference between these two entities, one may consider a healthy individual as Sthaulya (obese) and a pathological individual as Medho Sara.
Conventional cut-offs used to identify the risk at asymptomatic stage, do not fully appreciate Pathological adiposity and metabolic risk in Indians. In such a scenario, it is necessary to provide an alternative method, which will predict the metabolic risk at the early age.
A critical evaluation of Medho Dhatu (Adipose tissue) in the form of Sara and Sthaulya, and its relation with Bio-chemical changes may provide a simple method based on clinical assessment to predict the future risk and severity of these problems and will give specific view point for the prevention and treatment of these conditions. |