PDF of Trial CTRI Website URL

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Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 13:34:29 GMT)

CTRI Number CTRI/2018/02/011978 [Registered on: 19/02/2018] - Trial Registered Retrospectively Last Modified On 19/02/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Yoga & Naturopathy Study Design Randomized, Parallel Group Trial Public Title of Study Scientific study to know the effect of fasting and food in excessive weight individuals Scientific Title of Effect of Fasting therapy on Biochemical and autonomic changes in obese individuals- A Study Randomized Controlled Trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Prashanth Shetty Trial Coordinator (multi-center study) Designation Principal Affiliation SDMCNYS Address Room No 01, Professor, Department of Natural Therapeutics, Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences (SDMCNYS), Ujire, Dharmasthala, Dakshina kannada District, India Dakshina Kannada KARNATAKA 574240 India Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Naveen G H Query) Designation Research HOD Affiliation SDMCNYS Address Head of the department of Research and Assistant Professor, Room No 05, Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences (SDMCNYS), Ujire, Dharmasthala Dakshina Kannada KARNATAKA 574240 India Phone Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Naveen G H Designation Research HOD Affiliation Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Address Assistant Professor, Room No 05, Department of Research, Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Dharmasthala, Dakshina kannada District, India Dakshina Kannada

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KARNATAKA 574240 India Phone Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > AYUSH Ministry,AYUSH BHAWAN, B Block,GPO Complex, INA, NEW DELHI - 110023 Government of India Primary Sponsor Primary Sponsor Details Name Ministry of AYUSH Government of India Address MINISTRY OF AYUSH AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI 110023 Type of Sponsor Government funding agency Details of Secondary Name Address Sponsor Dr Naveen G H SDMCNYS, Ujire, karnataka Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Prashanth Shetty SDM Naturopathy and Department of Natural 08256236188 Yoga College Hospital Therapeutics, Fasting therapy division, Room [email protected] No 12, Ujire, m Belthangadi Taluk Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? SDMCNYSIEC Approved 24/07/2013 No Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Overweight and obese Intervention / Type Name Details Comparator Agent Intervention Fasting therapy Very low-calorie diet (288-904 kcal/day) for 10 days consisted of mainly fruit Juice. Comparator Agent Low calorie diet low-calorie diet (1234 kcal/day) for 10 days consisted of unseasoned boiled vegetables, chapati, daliya, vegetable/fruit salads and sprouts. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 40.00 Year(s) Gender Both Details 1. Obese individuals: BMI?25 kg / m2(as per criteria of diagnosis of obesity by the Ministry of Health and Family Welfare, Govt. of India)
2. Age between 18 and 40 years
3. Subjects of both

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genders will be included
4. Subjects who are not on any hormonal medications for past 2 months
Exclusion Criteria Exclusion Criteria Details 1.Obesity with co-morbid conditions 2.Obesity with systemic complications 3. Subjects taking any medications 4. Obesity secondary to hormonal abnormalities like PCOS, Hypothyroidism etc.

Method of Generating Computer generated randomization Random Sequence Method of On-site computer system Concealment Blinding/Masking Outcome Assessor Blinded Primary Outcome Outcome Timepoints 1. To compare the influence of Naturopathic Day 1 and day 11 between 7 and 8 am Fasting therapy and low calorie naturopathic diet in obese individuals on Lipid Profile (Total cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Very Low Density Lipoprotein, Serum triglycerides) and Serum Leptin

Secondary Outcome Outcome Timepoints To compare the influence of Naturopathic 10 days Fasting therapy and low calorie naturopathic diet in obese individuals on: ? Fasting Blood glucose and Post prandial Blood Glucose ? Heart rate variability

Target Sample Size Total Sample Size=100 Sample Size from India=100 Final Enrollment numbers achieved (Total)=88 Final Enrollment numbers achieved (India)=88 Phase of Trial N/A Date of First 09/02/2015 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details "None Yet"

Obesity is a metabolic disorder. Fasting therapy has been used as one of the treatment modalities in Naturopathy and Yoga field. Clinical obeservation suggest fasting therapy is beneficial to reduce weight. Howver, there is no research studies has been done to look at the changes in weight, leptin, Brief Summary lipid levels and autonomic changes with Naturopathy and Yoga intervention in obese individuals. We have put an attempt to address this issue in a comprehensive manner

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