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CTRI Number  CTRI/2016/02/006604 [Registered on: 03/02/2016] Trial Registered Prospectively
Last Modified On: 28/11/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bioavailability study of two Curcuminoids formulations of Drishtee Naturals Private Limited, India with two marketed Curcuminoids formulations in 20 Healthy adult human male subjects under fasting conditions.  
Scientific Title of Study   An open label, parallel, comparative bioavailability study of single oral dose of two Curcuminoids formulations incorporated in Cookies (each containing 200mg of Curcuminoids x 10 cookies) of Drishtee Naturals Private Limited, India with two marketed Curcuminoids formulations incorporated in Cookies (each containing 200mg of Curcuminoids x 10 cookies) in 20 Healthy adult human male subjects under fasting conditions.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj bablani 
Designation  Principal Investigator 
Affiliation  Auriga Research Limited 
Address  Auriga Research Limited, 3/15, Kirti Nagar Industrial Area, New Delhi
Auriga Research Limited, 3/15, Kirti Nagar Industrial Area, New Delhi
West
DELHI
110015
India 
Phone  09311234776  
Fax    
Email  pankaj.bablani@aurigaresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ramesh Magalmani 
Designation  CEO 
Affiliation  Drishtee Naturals Pvt. Ltd. 
Address  Drishtee Naturals Pvt. Ltd. No. 37, 1st Main Road Mathuri Layout, Nagashettyhalli, RMV 2nd Stage Sanjay Nagar, Bangalore
Drishtee Naturals Pvt. Ltd. No. 37, 1st Main Road Mathuri Layout, Nagashettyhalli, RMV 2nd Stage Sanjay Nagar, Bangalore
Bangalore
KARNATAKA
560094
India 
Phone  080-23512332  
Fax    
Email  ramesh.megalmani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manoj Karwa 
Designation  Head- Clinical Unit 
Affiliation  Auriga Research Limited 
Address  Auriga Research Limited, 3/15, Kirti Nagar Industrial Area, New Delhi
Auriga Research Limited, 3/15, Kirti Nagar Industrial Area, New Delhi
West
DELHI
110015
India 
Phone  011-45744540  
Fax    
Email  manojkarwa@aurigaresearch.com  
 
Source of Monetary or Material Support  
Drishtee Naturals Pvt. Ltd., no. 37, 1st Main Road Mathuri Layout, Nagashettyhalli, RMV 2nd Stage Sanjay Nagar, Bangalore 560094, India  
 
Primary Sponsor  
Name  Drishtee Naturals Pvt Ltd 
Address  Drishtee Naturals Pvt. Ltd., no. 37, 1st Main Road Mathuri Layout, Nagashettyhalli, RMV 2nd Stage Sanjay Nagar, Bangalore 560094, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Dr Pankaj Bablani  Auriga Research Ltd.  3/15, Kirti Nagar, Industrial Area
West
DELHI 		 09311234776

pankaj.bablani@aurigaresearch.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Good Society for Ethical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult human male subjects meeting inclusion and exclusion criteria 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparative Product- I (C1) : Cookies with Curcuminoids 95%   Single dose oral administration of 10 Cookies X 200 mg of Curcuminoids Cookies with Curcuminoids 95% of Salutaris Technologies Pvt. Ltd  
Comparator Agent  Comparative Product- II (C2) : Cookies with BCM-95 DC   BCM-95 DC Single dose oral administration of 10 Cookies X 200 mg of Curcuminoids, Cookies with BCM-95 DC of Arjuna Natural Extracts Ltd 
Intervention  Test Product –II (T2) : Cookies with BioTurCuSolâ„¢ 20 AS   Single dose oral administration of 10 Cookies X 200 mg of Curcuminoids, Curcuminoids 20% Aqueous Suspension of Drishtee Naturals Pvt. Ltd 
Intervention  Test Product-I (T1) : Cookies with BioTurCuSolâ„¢ 15 Powder  Single dose oral administration of 10 Cookies X 200 mg of Curcuminoids, Curcuminoids 15% Powder of Drishtee Naturals Pvt. Ltd  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  i. Subject who are able and ready to provide written informed consent.
ii. Subjects must be healthy male human beings within 18-45 years of age (both inclusive).
iii. Subjects should be having Body Mass Index (BMI) in the range 18.5-30 kg/m2, weighing at least 50 kg.
iv. Subjects must be of normal health as determined by medical history, physical examination, ECG and laboratory tests performed within 21 days prior to the commencement of the study.
v. Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
 
 
ExclusionCriteria 
Details  • Subjects incapable of understanding the informed consent process or not ready to sign informed consent.
• Subjects with significant history of hypersensitivity to Curcuminoids formulations or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
• Subject with of presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
• Subjects with active peptic ulceration or a history of peptic ulceration.
• Subject with resting hypotension (BP <90 /60) or hypertension (BP > 139 /89).
• Subject with Pulse rate 50/ min. and above 99/min.
• Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
• Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
• Subjects with a history of known food allergy.
• Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
• Subject who has difficulty with donating blood.
• Subject with positive Breath Alcohol Analysis before admission. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the bioavailability of single oral dose of two Curcuminoids formulations incorporated in Cookies (each containing 200mg of Curcuminoids x 10 cookies) of Drishtee Naturals Private Limited, India with two marketed Curcuminoids formulations incorporated in Cookies (each containing 200mg of Curcuminoids x 10 cookies) in 20 Healthy adult human male subjects under fasting conditions.   Time-Points for bioavailability estimation are -Pre dose (00.00 hour) sample will be collected within 02 hours prior to
Investigational Product administration and the post dose samples will be
collected at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50,
03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00 and 24.00 hours respectively. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor adverse events and assess safety and tolerability of Curcuminoids formulations in Cookies under fasting condition.  Vital signs - sitting blood pressure, radial pulse rate, oral temperature will be assessed at admission, prior to dosing (00.00 hrs) and at 02.00, 06.00 and 12.00 hours post-dose and at the time of checkout (24.00 hrs).  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/02/2016 
Date of Study Completion (India) 22/02/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Background

All the Curcuminoids products currently available in the market are predominantly used in Nutraceutical dosage forms like Capsules / Tablets.  Due to its poor solubility in water and poor Bio-availability, most often the absorption of Curcuminoids is very poor in a human system.

So, the formulation BioTurCuSolâ„¢ is to make the Curcuminoids more water soluble and bio-available in a matrix that are compatible and commonly used in all Food preparations and to break away from the conventional dosage forms like Tablets and Capsules.

So the Cookies incorporated with Test and Comparator Product manufactured by IICPT, Thanjavur.  This has also been formulated in such a way that it does not alter the taste and texture of the Food upon infusion into it, and it does not require either a prescription or a self-acquired knowledge about this bio-active for its health benefits as in the case of dosages forms like Tablets/Capsules.

Following are the Investigational Products to be compared for Bioavailability of Curcuminoids in blood.

·         C1 : Cookies incorporated with Curcuminoids 95%

·         C2 : Cookies incorporated with BCM 95 [Curcuminoids 95%]

·         T1 : Cookies incorporated with BioTurCuSolâ„¢  15 Powder  [Curcuminoids 15% Powder]

·         T2 : Cookies incorporated with BioTurCuSolâ„¢  20 AS  [Curcuminoids 20% Aqueous suspension]

     Study Rationale:

Curcumin, in spite of its proven efficacy on its anti- inflammatory, anti-microbial, anti- cancer, Cognitive and Cardio functions, has invariably been found to be low in bio-availability due to the fact that it is either converted into its inactive metabolites and / or its poor absorption in the human digestive system. 

Most of the Natural Bio-actives have been produced and marketed in the Nutraceutical / Dietary supplement markets in the form of Dosages like Capsules, Tablets and Liquid orals without proven bio-availability and poor bio-efficacy and the entire segment has become highly competitive.

In-order to create a niche value added product market, leveraging the current lacuna in the existing product ranges such as poor bio-availability of  Bio-actives, its poor water solubility & lipid solubility and its compatibility with all food products like Diary products [Milk, Yogurt, Cheese, Butter, Ice-cream, Chocolates etc.,]  Beverages [Fruit and Alcoholic],  Baked Foods [Biscuits, Cookies, Pastries, Bread / Cakes etc., ], Confectionary [Toffees, Candies],  Jellies/ Jams / Sauce etc., 

Drishtee has developed an unique technology for  the  formulation of BioTurCuSolâ„¢ (Curcuminoids 20 %  in Aqueous suspension  and 15% Powder) with increased & high bio-availability and water solubility that can be infused into any kind of above mentioned Foods with very high compatibility without having to take these bio-actives in the form of Capsules /  Tablets. 

The biggest advantage of infusing these highly bio-available and compatible bio-active in all Food preparations is in not changing the life style of the consumer without altering their Food habits and the taste & texture of the Food and at the same time infusing Health and Wellness into their Food and Life, at cheaper cost.

Drishtee has chosen cookies as food product to test the bioavailability of BioTurCuSolâ„¢ Powder and Aqueous Solutions in comparison with Marketed Products.

 

 

 

 

 

 

 
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