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CTRI Number  CTRI/2019/12/022484 [Registered on: 23/12/2019] Trial Registered Prospectively
Last Modified On: 22/06/2020
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Bioavailability study of Curcuminoid and Lutein combination in healthy subjects  
Scientific Title of Study   A randomized, open label, single center, one period, single dose, three arm bioavailability study of Curcuminoid and Lutein combination based formulations in healthy human adult male subjects, under fasting conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
FFF/CURLU/BA/2019 Version 1.0 dated 21st Nov 2019   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi  
Designation  Director  
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Radiant Research Services Pvt. Ltd 99/A, 8 Main, III Phase Peenya Industrial Area, Bangalore-

Bangalore
KARNATAKA
560058
India 
Phone  09880999297   
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Scientific Query  
Name  Mr A T Jocob  
Designation  Managing partner 
Affiliation  FFF Bio Works LLP 
Address  FFF Bio Works LLP No 2675, 4th Cross, 17th Main, HAL 2nd Stage,Indiranagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560008
India 
Phone  09844019547  
Fax    
Email  jacob.at@fffbioworks.com  
 
Details of Contact Person
Public Query  
Name  Mr Jayaram M 
Designation  Senior manager R&D  
Affiliation  FFF Bio Works LLP 
Address  FFF Bio Works LLP No 2675, 4th Cross, 17th Main, HAL 2nd Stage,Indiranagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560008
India 
Phone  09986123479  
Fax    
Email  jayaram@fffbioworks.com  
 
Source of Monetary or Material Support  
FFF Bio Works LLP No 2675, 4th Cross, 17th Main, HAL 2nd Stage, Indiranagar, Bengaluru, Karnataka 560008  
 
Primary Sponsor  
Name  FFF Bio Works LLP 
Address  No 2675, 4th Cross, 17th Main, HAL 2nd Stage, Indiranagar, Bengaluru, Karnataka 560008  
Type of Sponsor  Other [Pharmaceutical Product developement copmany ] 
 
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 Amaranth Reddy  Shettys Hospital  Plot No 11 and 12 12th F Main Rd Kaveri Nagar Bommanahalli Bengaluru Karnataka 560068
Bangalore
KARNATAKA 		 08040943039

dramarclinicblr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
shettys hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy subjects  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm 1: Test Formulation I 120:20 mix Arm2 : Test Formulation II 30:5 mix  administered orally single dose  
Comparator Agent  Curcuminoid formulation 500mg dose  administered orally single dose  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1.Subjects must be healthy human male subjects.
2.Age should be between 18-65 years of age (both inclusive), weighing at least 50 kg.
3.Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol.
4.Subjects with no evidence of underlying disease during the pre-study screening
5. They must be healthy as determined by medical history and physical examination and laboratory tests performed within 14 days prior to the commencement of the study.
6.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
 
 
ExclusionCriteria 
Details  1. Subjects who are allergic to turmeric or its extracts or curcuminoids or lutein or any food or other drugs.
2. Subject with resting hypotension (BP <90 /60) or hypertension (BP > 140 /90) and pulse rate below 50/min and more than 100/min.
3. Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing.
4. Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
5. Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
6. Subject who have a History of alcoholism, drug abuse or Smoking.
7. Subjects who are hypersensitive to Heparin
8. Subjects who participated in any other clinical study in the past three months.
9. Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X-ray (PA View).
10. Subject who has difficulty with donating blood.
11. Subject with history of difficulty in swallowing.
12. Subject who has unsuitable veins for repeated venipuncture
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the bioavailability of curcuminoids and lutein in respective Curcuminoid and Lutein combination based formulations  0:00 min, 30 min, 1, 2, 3, 4, 6 and 24hrs.  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective of this study is to monitor the safety and tolerability of a single dose of Curcuminoid and Lutein combination formulations in healthy human adult male subjects, under fasting conditions.  0 hr to 24 hrs  
 
Target Sample Size   Total Sample Size="9"
Sample Size from India="9" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
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)?  

Brief Summary  

The  study conducting in healthy human male subjects to find out  Curcuminoid and Lutein combination bioavailability in the body


 Curcumin is the principal curcuminoid of the popular Indian spice turmeric (Curcuma longa), which is an rhizomatous herbaceous perennial plant of Zingiberaceae family which is native to tropical South Asia.

 

Marigold flower (Tagetes erecta L.) represents a rich source of lutein. It is grown for business purposes in Mexico, Peru, Ecuador, Spain, India or China. Dried Marigold flowers contain 0.1–0.2% dry matter (DM) of carotenoids, out of which 80% are lutein diesters. By the extraction of dried and ground flowers, a non-polar oleoresin extract is acquired

 


 
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