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CTRI Number  CTRI/2024/04/065098 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 01/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Naturopathy Diet on the cardiovascular health among asymptomatic hardening of arteries.  
Scientific Title of Study   Effect of Naturopathy based dietary intervention on the cardiovascular health index of sub clinical atherosclerosis.  
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 SHALMALI 
Designation  PG SCHOLAR 
Affiliation  Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Department of Nutrition, Ground floor, College Building, Siddhavana. Taluk: Belthangady

Dakshina Kannada
KARNATAKA
574240
India 
Phone  8762116167  
Fax    
Email  shalmalisunil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth Shetty 
Designation  Principal 
Affiliation  Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Shri Dharmasthala MAnjunatheshwara college of Naturopathy and Yogic Science, Ground Fllor, Siddhavana, Colege Road, Ujire. Taluk: Belthangady

Dakshina Kannada
KARNATAKA
574240
India 
Phone  8762116167  
Fax    
Email  drprashanth9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SHALMALI 
Designation  PG SCHOLAR 
Affiliation  Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire 
Address  Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Department of Nutrition, Ground floor, College Building, Siddhavana. Taluk: Belthangady

Dakshina Kannada
KARNATAKA
574240
India 
Phone  8762116167  
Fax    
Email  shalmalisunil@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara Multi-Speciality Hospital, National Highway 234, Charmadi Road, Ujire. Taluk Belthangady District: Dakshina Kannada 
 
Primary Sponsor  
Name  Dr. Shalmali 
Address  Sampanna Shivajinagar Ujire Belthangady Taluk 574240  
Type of Sponsor  Other [Principal Investigator ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalmali  SDM Hospital Ujire  Shri Dharmasthala MAnjunatheshwara Multi-Speciality Hospital, Ground Floor, Department of Biochemistry and Laboratory, National Highway 234, Charmadi Road, Ujire. Taluk: Belthangady 574240
Dakshina Kannada
KARNATAKA 
8762116167

shalmalisunil@gmail.com 
Dr Shalmali  Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire  Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Department of Nutrition and Dietitics, Ground Floor, Old wing, College Building College Road, Siddhavana, Ujire. Taluk: Belthangady.
Dakshina Kannada
KARNATAKA 
8762116167

shalmalisunil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire - Institutional Ethical Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I709||Other and unspecified atherosclerosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dietary interventions for 90 days  Lemon water, 4 Almonds, 2 cashews, 2 Walnuts, 2 Pistachios, 1 tea spoon of raisins (overnight soaked) Regular breakfast Any fruit/Cucumber slices/Tender coconut water 250gms raw salad with groundnut,2 pcs of papaya/seasonal fruit,250 ml buttermilk Coffee/tea Regular dinner, Mosambi Juice, Beetroot juice, Tomato juice, Pomegranate juice, A bowl of seasonal fruits (2-3 varieties) Any fruit/Cucumber slices/Tender coconut water. 
Comparator Agent  No Dietary Intervention  Normal Regular Diet 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Atherogenic index greater than 0.21

 
 
ExclusionCriteria 
Details  History of Cardiovascular disease
Any other systemic illness
 
 
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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum Lipid Profile
Complete Blood Count
Fasting Blood Glucose
Clinical Anthropometry
 
Pre data will be measured on day 1 and post data will be measure on day 91. 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Anthropometry
Body composition analysis 
Pre data will be measured on day 1 and post data will be measure on day 91. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 1/ Phase 2 
Date of First Enrollment (India)   15/04/2024 
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 Yet Recruiting 
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  

Cardiovascular disease (CVD) remain a leading cause of death globally. The concept of acute myocardial infarction in young adults was uncommon. Atherosclerosis is the leading cause of CVD, including myocardial infarction, stroke, heart failure and peripheral artery disease. This condition is initiated early in childhood and progressive in nature. CVD risk factors includes hypertension, dyslipidemia and obesity play a role in the development of atherosclerosis and components in insulin resistance syndrome

Data from seven observational studies suggest that subclinical atherosclerosis defined by increased cIMT or CACS is associated with an increased risk of incident Atrial Fibrillation. These findings emphasize the need for further research investigating whether treatment of subclinical atherosclerosis should be a part of the initiatives to prevent AF.[ Kristensen KE, Knage CC, Nyhegn LH, Mulder BA, Rienstra M, Van Gelder IC, Brandes A. Subclinical atherosclerosis is associated with incident atrial fibrillation: a systematic review and meta-analysis. Europace.

 

         Atherosclerosis starts early in life and progresses silently for decades. Considering atherosclerosis as a "systemic disease" invites the use of noninvasive methodologies to detect disease in various regions before symptoms appear. 

The prevalence of subclinical atherosclerosis varies across body size phenotypes. Pharmacologic and lifestyle interventions might modify their cardiovascular risk by facilitating the transition from one phenotype to another. Therefore efforts are made to conduct scientific studies on effect of dietary interventions on cardiovascular health of people with subclinical atherosclerosis. 

 
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