| CTRI Number |
CTRI/2024/07/070617 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment of Effect of Yoga including Diet on Cognitive functions among Hypertensives |
|
Scientific Title of Study
|
A Study to assess the Effect of Yoga and Diet on Cognitive functions among Hypertensive subjects at RUHS College of Medical Sciences and associated Hospitals Jaipur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arsheen Hasan |
| Designation |
M.D. Physiology Resident |
| Affiliation |
Post Graduate resident, Rajasthan University of Health Sciences, College of Medical Sciences, Jaipur |
| Address |
Department of Physiology Rajasthan University of Health Sciences College of Medical Sciences First floor room number 23 Sector 11 Kumbha Marg Pratap Nagar Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
9111613878 |
| Fax |
123 |
| Email |
arsheen.hasan@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Neha Saboo |
| Designation |
Associate Professor, Department of Physiology |
| Affiliation |
Rajasthan University of Health Sciences, College of Medical Sciences |
| Address |
Department of Physiology Rajasthan University of Health Sciences College of Medical Sciences First floor room number 23 Sector 11 Kumbha Marg Pratap Nagar Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
9111613878 |
| Fax |
123 |
| Email |
nehasaboo8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arsheen Hasan |
| Designation |
M.D. Physiology Resident ,Department of Physiology |
| Affiliation |
Rajasthan University of Health Sciences, College of Medical Sciences |
| Address |
Department of Physiology Rajasthan University of Health Sciences College of Medical Sciences First floor room number 23 Sector 11 Kumbha Marg Pratap Nagar Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
9111613878 |
| Fax |
123 |
| Email |
arsheen.hasan@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Rajasthan University of Health Sciences, College of Medical Sciences, Sector 11, Kumbha Marg, Pratap Nagar, Tonk Road, Sanganer Jaipur 302033, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
Rajasthan University of Health Sciences College of Medical Sciences |
| Address |
Sector 11, Kumbha marg, Pratap nagar,Jaipur,Rajasthan Pin code 302033 |
| 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 |
| DrArsheen hasan |
Rajasthan University of Health Sciences, College of Medical Sciences |
First floor, room number 21,Sector 11, Kumbha marg, Pratap nagar,Jaipur,Rajasthan
Jaipur
RAJASTHAN |
9111613878
arsheen.hasan@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS-CMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Yoga and Diet |
Yoga for 45 mins,6 days a week for 6 months will be advised followed by diet chart,follow up will be done after baseline on 3 months and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 30-70 years
Subjects who will give written informed consent
Subjects who have not practiced any form of yoga or exercise in the past
Subjects at risk of hypertension
Hypertensive subjects with medications |
|
| ExclusionCriteria |
| Details |
Subjects have already performed a healthy routine of physical activity in the last three months.
Pregnant and nursing mothers.
Type II Diabetic patients.
Subject having severe disabilities like Kyphosis, Scoliosis, Osteoarthritis Mental disorders.
Subjects with liver disorders and lung disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anthropometric Parameters (age,height,weight, waist and hip circumference),Physiological Parameters ( pulse and BP )
c) Biochemical Parameters ( fasting blood sugar, lipid profile,Risk Score Calculation using Quality of Life Score and MMSE and MoCA A and B,Perceive stress score will be calculated at Baseline than after 3 months and 6 months. |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Awareness & Lifestyle modification |
3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
26/07/2024 |
| 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="0"
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
|
I will recruit stable hypertensive patients between age group of 30 yrs to 70 yrs from medicine opd of RUHS-CMS Hospital and from RDBP Jaipuria Hospital. After recruitment Proforma about their socio-demographic status, Anthropometric parameter, Vitals are to be filled. Cognitive functions will be checked using P300,Questionaire MMSE, MOCA and B, PSS, Quality of life score. Then these patient will be advised to do 6 month yoga for 45 mins 6 days a week and will follow a diet chart. Comparison of cases will be done by age matched Healthy volunteers, Blood pressure and Cognitive test wiil be done for Control group also but without interventions. Follow up will be done at interval of 3 months and 6 months after Yoga and Diet. |