| CTRI Number |
CTRI/2015/06/005934 [Registered on: 22/06/2015] 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
|
An open label, parallel, comparative bioavailability different Curcuminoids formulations incorporated in Cookies (each containing 40mg of Curcuminoids x 10 cookies) and Placebo in 15 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 40mg of Curcuminoids x 10 cookies) of Drishtee Naturals Private Limited, India with two marketed Curcuminoids formulations incorporated in Cookies (each containing 40mg of Curcuminoids x 10 cookies) and Placebo in 15 Healthy adult human male subjects under fasting conditions. |
| Trial Acronym |
|
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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,
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
Maruthi Layout, Nagashettyhalli,
RMV 2nd Stage Sanjay Nagar,
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,
West
DELHI
110015
India |
| Phone |
011-45754540 |
| Fax |
|
| Email |
manojkarwa@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
| Drishtee Naturals Pvt. Ltd.
No. 37, 1st Main Road
Maruthi Layout, Nagashettyhalli,
RMV 2nd Stage Sanjay Nagar,
Bangalore 560 094,
India |
|
|
Primary Sponsor
|
| Name |
Drishtee Naturals Pvt Ltd |
| Address |
No. 37, 1st Main Road
Maruthi Layout, Nagashettyhalli,
RMV 2nd Stage Sanjay Nagar,
Bangalore 560 094,
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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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 |
| Dr Pankaj Bablani |
Auriga Research Limited |
Clinical Research Division, 3/15 Kirti Nagar Industrial Area,
New Delhi
West
DELHI |
09311234776
pankaj.bablani@aurigaresearch.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult human male subjects meeting inclusion and exclusion criteria |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparative Product- I (C1) : Cookies with Curcuminoids 95% |
Single dose oral administration of 10 Cookies X 40 mg of Curcuminoids
Cookies with Curcuminoids 95% of Salutaris Technologies Pvt. Ltd |
| Comparator Agent |
Comparative Product- II (C2) : Cookies with BCM-95 DC |
Single dose oral administration of 10 Cookies X 40 mg of Curcuminoids, Cookies with BCM-95 DC of Arjuna Natural Extracts Ltd |
| Comparator Agent |
Placebo (P) : Plain And Normal Cookies |
Single dose oral administration of 10 Cookies X Plain And Normal |
| Intervention |
Test Product –II (T2) : Cookies with BioTurCuSol™ 20 AS |
Single dose oral administration of 10 Cookies X 40 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 40 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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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 40mg of Curcuminoids x 10 cookies) of Drishtee Naturals Private Limited, India with two marketed Curcuminoids formulations incorporated in Cookies (each containing 40mg of Curcuminoids x 10 cookies) and Placebo in 15 Healthy adult human male subjects under fasting conditions. |
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. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor adverse events and assess safety and tolerability of Curcuminoids formulations in Cookies under fasting condition. |
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. |
|
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Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/07/2015 |
| Date of Study Completion (India) |
03/07/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
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 BioTurCuSol™ 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. In the similar manner Placebo product (Plain and Normal Cookies) are also formulated at IICPT, Thanjavur for comparison purpose. 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 BioTurCuSol™ 15 Powder [Curcuminoids 15% Powder] · T2 : Cookies incorporated with BioTurCuSol™ 20 AS [Curcuminoids 20% Aqueous suspension] · P : Placebo
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. |