| CTRI Number |
CTRI/2023/09/057482 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of diet and lifestyle on obesity with deha prakriti |
|
Scientific Title of Study
|
A study on diet and lifestyle of overweight and obese (Medo-roga) patients and their association with Deha Prakriti |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vandana Singh |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department Of Vikriti Vigyan, Faculty Of Ayurveda, Institute Of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8127742674 |
| Fax |
|
| Email |
vandanasingh2109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Priyadarshini Tewari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department Of Vikriti Vigyan, Faculty Of Ayurveda, Institute Of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8090029260 |
| Fax |
|
| Email |
pgtpriya55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Priyadarshini Tewari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department Of Vikriti Vigyan, Faculty Of Ayurveda, Institute Of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8090029260 |
| Fax |
|
| Email |
pgtpriya55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, BHU, Varanasi. |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science, Banaras Hindu University, UP |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University |
| Type of Sponsor |
Government medical college |
|
|
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 Vandana Singh |
Sir Sundarlal Hospital |
Department Of Vikriti Vigyan, Faculty Of Ayurveda, Institute Of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH |
8127742674
vandanasingh2109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IMS |
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 |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases of overweight and obese patients coming to OPD(IM) wing, SS hospital.
2. Age Group: 21 to 60 years.
3. Gender: male and female.
4. Rural, semi-rural and urban patient.
5. BMI above than 25 or waist circumference greater than 102cm in males and 88 in females |
|
| ExclusionCriteria |
| Details |
1. Pregnant Woman.
2. Below 21 years and above 60 years.
3. Refusal to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predisposing dietary & lifestyle factors responsible for overweight & obesity |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of overweight & obesity & their association with Deha Prakriti |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
20/09/2023 |
| 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 is a common worldwide problem in which body has collected excess fat that may cause an adverse effect on the body. Overweight and obesity is responsible for may lifestyle threatening diseases like Type II diabetes, gallbladder diseases, gastrointestinal diseases and hepatic disorders, respiratory diseases, psychological diseases etc. This study is an observational study to evaluate the diet and life style of overweight and obese (medoroga) patients and their association with deha prakriti. The study will be carried out at the OPD of IM wing of SS hospital, BHU. After registration of the patients, the required data will be collected through personal interview method. Dietary changes and lifestyle modifications will be advised to the patients to control their weight gain and will be motivated to achieve normal body weight and healthy lifestyle. |