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CTRI Number  CTRI/2016/05/006977 [Registered on: 31/05/2016] Trial Registered Retrospectively
Last Modified On: 31/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VEGETABLE POWDER IN THE MANAGEMENT OF CARDIOVASCULAR RISK FACTORS. 
Scientific Title of Study   A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VEGETABLE POWDER IN THE MANAGEMENT OF CARDIOVASCULAR RISK FACTORS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/CR/ITC/0711/39 Version 01 Dated 07-NOV-2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajanna Muniswamappa  
Designation   
Affiliation  Bangalore Diabetes Center  
Address  #426,IV Cross,II Block,Kalyan Nagar,Bangalore Bangalore KARNATAKA Bangalore KARNATAKA

Bangalore
KARNATAKA
560043
India 
Phone  9886399730  
Fax    
Email  dr.rajanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harisha S 
Designation  Director- Operations  
Affiliation  ICBio Clinical research Pvt Ltd 
Address  ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore.

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query  
Name  Dr Harisha S 
Designation  Director - operations  
Affiliation  ICBio Clinical research Pvt Ltd 
Address  ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore.

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
ITC Limited 
 
Primary Sponsor  
Name  ITC Limited 
Address  ITC Life Sciences & Technology Centre # 1st Main Pennya Industrial Area, Phase 1, Bengaluru - 56 0058, India  
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surabhis  Ananya Ayurveda Center   #438,1st main,2ndcross,3rdblock, 3rd stage,Basweshwaranagar
Bangalore
KARNATAKA 		 9886866331

surupranu@gmail.com 
Dr Rajanna Muniswamappa   Bangalore Diabetic Center   #426,IV Cross,II Block,Kalyan Nagar,Bangalore Bangalore KARNATAKA Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9880367101

dr.rajanna@gmail.com 
Sheela Thorat  Mediciti Superspeciality Hospital  mediciti hospitals 3-3-579/580 Kutibiguda
Hyderabad
ANDHRA PRADESH 		 9885047149

sheelathorat@rediff.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Mediciti Ethics committee  Approved 
Medisys Clinisearch Ethical Review Board  Approved 
SRI VENKATESHWARA HOSPITAL ETHICS COMMiTTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I998||Other disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PLACEBO  Two capsules at a time, per day for 84 days. 
Intervention  Vegetable powder Capsules (VP70) 400 mg   Two capsules at a time, per day for 84 days.  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Males and females of age group 18-60 years
• Patients with diabetes (FBS greater than or equal to 130 mg/dL , PPBS greater than or equal to 200 mg/dL)
• Obese patients with Body mass index 25 to 35 kg/m2.
• Patients prone to Cardiovascular disease (Triglycerides greater than or equal to 150 mg/dl)
• Subjects must understand risks and benefits of the protocol and be able to give informed consent along with audio video visual.
• Equal distribution of subjects receiving medication amongst the test and placebo arms
 
 
ExclusionCriteria 
Details  • History of thyroid diseases
• History of HIV positive patients
• Pregnant or lactating woman
• Cancer, smoking, alcohol drinking.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
• Management of Cardiovascular risk factors (Changes in the Triglycerides)  Screening to visit 5( Day 84) 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Quality of life questionnaire
Changes in the FBS,PPBS
Changes in the ECG, Lipid Profile, LFT, KFT, HbA1c, BMI, Weight, anthropometric measures.
Incidence and rate of adverse events
Blood pressure,PP Triglycerides
 		 Screening to Visit 5(Day 84) 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
Final Enrollment numbers achieved (Total)= "288"
Final Enrollment numbers achieved (India)="288" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/04/2015 
Date of Study Completion (India) 31/08/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VEGETABLE POWDERIN THE MANAGEMENT OF CARDIOVASCULAR RISK FACTORS. 
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