Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 06:09:13 GMT)

PDF of Trial CTRI Website URL - http://ctri.nic.in

CTRI Number CTRI/2020/09/028014 [Registered on: 24/09/2020] - Trial Registered Prospectively Last Modified On 21/09/2020 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Yoga & Naturopathy Study Design Randomized, Parallel Group Trial Public Title of Study Study comparing raw vegetables and fruits on weight and blood cholesterol on fat individuals Scientific Title of A comparative study on raw vegetable diet and fruit diet on body composition and lipid profile Study among obese individuals Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sahana Bhandary M Trial Coordinator (multi-center study) Designation PG student MD Nutrition Affiliation SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES Address Ground floor Department of Nutrition SDM college of Naturopathy and Yogic sciences Ujire Belthangady Dakshin Kannada district Karnataka state SDM college of Naturopathy and Yogic sciences Ujire Belthangady Dakshina kannada district Karnataka state Dakshina Kannada KARNATAKA 574240 India Phone 7259554839 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Prashanth Shetty Query) Designation Principal Affiliation RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES Address SDM College of naturopathy and yogic sciences ujire Belthangady taluk Dakshina kannada SDM College of naturopathy and yogic sciences ujire Belthangady taluk Dakshina kannada Dakshina Kannada KARNATAKA 574240 India Phone 9448252696 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Sahana Bhandary M Designation PG student MD Nutrition Affiliation SDM COLLEGE OF NATUROPATHY AND YOGIC SCIENCES Address Ground floor Department of Nutrition SDM Yoga and Nature cure hospital Shanthivana Dharmasthala Belthangady Taluq Dakshina Kannada District Ground floor Department of Nutrition SDM Yoga and Nature cure hospital Shanthivana Dharmasthala 574216 Belthangady Taluq

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Dakshina Kannada KARNATAKA 574216 India Phone 7259554839 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > SDM Yoga and Nature Cure Hospital Shanthivana Dharmasthala 574216 Dakshina Kannada District Karnataka South India [email protected] Primary Sponsor Primary Sponsor Details Name Dr Sahana Bhandary M Address SDM Yoga and Nature cure hospital Shanthivana Dharmasthala Type of Sponsor Other [SELF] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sahana Bhandary M SDM Nature cure First floor Department 7259554839 hospital of Research ANVESHANA bhandarysana94@gmai Shanthivana l.com Dharmasthala Dakshina kannada Karnataka Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? SDM college of Approved 29/04/2020 No naturopathy and Yogic sciences Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Obesity due to excess calories Intervention / Type Name Details Comparator Agent Intervention Fruit Diet with yoga and Fruit diet with yoga therapy, naturopathy treatment naturopathy treatments like hydrotherapy, massage therapy,mud therapy for 10 days Comparator Agent Raw vegetable diet with yoga Raw vegetable diet with yoga therapy and naturopathy therapy and Naturopaty treatments treatments like hydrotherapy, mud therapy,massage therapy for 10 days Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s)

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Gender Both Details Subjects under BMI 27kg/m2,not being diagnosed of diabetes, hypercholesterolemia,and mental disorder. Exclusion Criteria Exclusion Criteria Details Major illnesses, diabetes mellitus,heavy alcohol consumption, recent acute or chronic disease, changing medications affect weight, weight loss >5 kg in last 3 months, fluctuating exercise patterns, strenuous exercise >1 h per day, dietary limitations, and dislike of vegetables. Cardiovascular, kidney, liver, thyroid or renal diseases, endocrine disorders; cancer or AIDS; use of medications that could influence lipid or carbohydrate metabolism (thiazides, ?-blockers, glucocorticoids, weight-loss medications, thyroid hormone, or hypolipidemic drugs); pregnancy or lactation. Method of Generating Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Alternation Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints body fat water percentage body mass index Low 1st and 10th day of intervention density lipoprotein level Total cholestrol Triglyceride Secondary Outcome Outcome Timepoints Total body weight 1st and 10th day of intervention Target Sample Size Total Sample Size=60 Sample Size from India=60 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 02/11/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=2 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NIL Brief Summary ToAim of the study is to assess the effect of raw vegetable on body composition and lipid profile among obese individuals and to assess the effect of fruit on body composition and lipid profile among obese individuals. The subjects will be recruited from inpatient department of SDM Yoga and Nature cure hospital, Shanthivana, Dharmasthala, Karnataka. The subjects will be screened as per the inclusion and

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exclusion criteria and subjects who fulfill both the criteria will be considered for the study. Patient of age 18 – 65 years of age, both males and females having a BMI ?27 kg/m2 and subjects who are interested in pursuing weight loss are included. It is a Randomized controlled trail where there are total of 60 subjects are included out of which 30 subjects will be given fruit intervention and other 30 subjects will be given raw vegetable intervention along with yoga and naturopathy treatments for 10days. Baseline assessments will be body composition, anthropometric measurements and lipid profile. The study is done to assess the improvement in quality of life among obese individuals and to assess the effect of raw vegetable and fruit among obese individuals.

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