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CTRI Number  CTRI/2021/02/031066 [Registered on: 08/02/2021] Trial Registered Prospectively
Last Modified On: 17/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical trial on overweight adult healthy volunteers  
Scientific Title of Study   A randomized, double blind, parallel assignment, placebo-controlled, two arm study to evaluate the safety and efficacy of iPulse (multi fruit blend juice) in overweight adult healthy volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/IPL/OW/2020 Version 1.0 dated 16th Mach 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research services pvt. Ltd.  
Address  Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, 560058, Karnataka, India.

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research services pvt. Ltd.  
Address  Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, 560058, Karnataka, India.


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Public Query
 
Name  Dr Balu kolar 
Designation  Manager-Product developement 
Affiliation  INDUS VIVA HEALTH SCIENCES PVT.LTD 
Address  INDUS VIVA HEALTH SCIENCES PVT.LTD Nandi Durga Rd, Jayamahal Extension, Benson Town, Bengaluru, Karnataka 560046

Bangalore
KARNATAKA
560046
India 
Phone  9902557065  
Fax    
Email  dr.balu@indusviva.com  
 
Source of Monetary or Material Support  
IndusViva HealthSciences Pvt. Ltd., Nandi Durga Rd, Jayamahal Extension, Benson Town, Bengaluru, Karnataka 560046 
 
Primary Sponsor  
Name  IndusViva HealthSciences Pvt Ltd 
Address  Nandi Durga Rd, Jayamahal Extension, Benson Town, Bengaluru, Karnataka 560046 
Type of Sponsor  Other [Health & Wellness Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrShubarani   Sushrutha Ayurvedic Medical College And Hospital  Ground Floor Room nuber 3 Prashanti Kuteera jodi Bingipura, Jigani Hobli, Anekal, Taluk, Bengaluru, Karnataka 560105
Bangalore
KARNATAKA 
9449453674

dr.shubharani111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shettys Hospital -Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Over weight  
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  i-Pulse (rich multi fruit blend juice)  Day 0 to Day 60 Route of administration: orally Dosage form: liquid Duration : 90 days Dose:30 ml Frequency: twice daily Before break fast and Dinner  
Comparator Agent  Placebo (Oral juice)  Day 0 to Day 60 Route of administration: orally Dosage form: liquid Duration : 90 days Dose:30 ml Frequency: twice daily Before break fast and Dinner 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) Age/sex: men and women (1:1, equal distribution) aged 18-55 years (Preferably subgroup of age 18-35 and age 36-55, if feasible)
2) Subject with BMI 25-30 kg/m2
3) Subjects who perceive themselves to be under stress and having a score of 14-24 on the Perceived Stress Scale (PSS).
4) Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator
5) Subject willing to provide written informed consent and comes for regular follow up.
6) Subjects who agree to stop from using supplements during the study
7) Subjects willing to follow the suggested diet plan
 
 
ExclusionCriteria 
Details  1) Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
2) Known history of any chronic illness taking regular pharmacological agents.
3) Significant Gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease
4) Cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure)
5) History of major cardiovascular events in the last 1 year (stroke or myocardial infraction)
6) History of drug dependence or any severe co-morbid medical conditions.
7) High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc., Nicotine/Caffeine dependence.
8) Administration of any other multivitamins/herbal product/wellness products
9) Subject has participated in a clinical study within the last 30 days prior to entering this study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Primary Measurement will be the safety and tolerability of iPulse through Laboratory Parameters  Baseline, 4 weeks and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
2. Secondary Measurement will be to assess the efficacy of I-Pulse through Demographics (Body weight, BMI, Waist circumference)  Day 0,Day 45 and Day 90 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   08/02/2021 
Date of Study Completion (India) 15/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Obesity and metabolic syndrome are considered to be major public health crises not only in the United States but also globally. An expert panel convened by the National Institutes of Health has defined overweight as a body mass index (BMI) of 25 to 29.9 kg/m2 and obesity as a BMI of 30 kg/m2 or greater. According to the World Health Organization (WHO), as of 2005 there were approximately 1.6 billion overweight adults globally, of whom at least 300 million were clinically obese. The prevalence of overweight and obese American adults has steadily increased over the years in both genders, at all ages, in all racial and ethnic groups, at all educational levels, and for all smoking levels. Most studies show an increase in mortality rates associated with obesity. Individuals who are obese have a 10%–50% increased risk of death from all causes, compared with healthy-weight individuals. Most of the increased risk is due to cardiovascular causes. Obesity is associated with about 112,000 excess deaths per year in the U.S. population relative to healthy-weight individuals.

iPulse has numerous effects on the body. iPulse contains a rich blend of antioxidant fruits which mainly protects us from numerous diseases for wellbeing and healthy life. It prevents us from the neurodengerative problems, supports healthy memory, helps to prevent respiratory related problem, improves resistance against allergies, protection of liver, controls the homeostasis level, helps reduce GI problems, it maintains healthy vision, improves circulation in the eyes, helps to synthesis of plasma cells (WBS, RBC and platelets), supports healthy haemoglobin level and healthy immunity


 
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