| 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
|
|
|
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
|
|
|
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. |