| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Over weight |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAMÂ (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
|