| CTRI Number |
CTRI/2017/05/008702 [Registered on: 31/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
A study on 28 healthy adult males to check the concentration of different forms of Curcumin in their blood. |
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Scientific Title of Study
|
A randomized, pilot double blind, single center, one period, single dose, four arm bio-availability study of Curcumin formulations in 28 healthy human adult male subjects, under fasting conditions.
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| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/TATA/CUR/BA/2017, Version-01 dated 25Mar2017 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divakara P |
| Designation |
Principal Investigator |
| Affiliation |
3k Healthcare |
| Address |
3k Healthcare
#LL3, Banaswadi,
Department of Medicine,
Room number -01,Outer Ring Road Horamavu, Bangalore
Bangalore
KARNATAKA
560043
India |
| Phone |
09886081283 |
| Fax |
|
| Email |
deepu21081@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saikat Roy |
| Designation |
Scientist |
| Affiliation |
Tata Chemicals Ltd |
| Address |
Tata Chemicals Ltd
Scientic Dept,
Ambedveth (V),
Mulshi,
Pune.
Pune
MAHARASHTRA
412 108
India |
| Phone |
09049708083 |
| Fax |
|
| Email |
sairoy@tatachemicals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd
Clinical Division,
Room No-02
#99/A, 8 Main, III Phase
Peenya Industrial Area,
Bangalore
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
ashok@radiantresearch.in |
|
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Source of Monetary or Material Support
|
| Tata Chemicals Ltd,
Ambedveth (V),
Mulshi,
Pune- 412 108,
Maharashtra |
|
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Primary Sponsor
|
| Name |
Tata Chemicals Ltd |
| Address |
Ambedveth (V),
Mulshi,
Pune - 412 108
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| Type of Sponsor |
Other [Manufacturer, Limited Company] |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divakara P |
3k Healthcare |
Department of Medicine,
Room No-01
No LL3, Banaswadi, Outer Ring Road Horamavu, Bangalore - 560043
Bangalore
KARNATAKA |
09886081283
deepu21081@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Independent Ethics Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Healthy Human Volunteers |
BA/BE Study |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curcumin Powder |
Turmeric Extract, 4gm, once a day, orally for one day. |
| Intervention |
Curcuminoid-Green tea extract |
Turmeric Extract and Green Tea Extract, 4gm, once a day, orally for one day. |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sustential Curcumin powder |
Turmeric Extract and Green Tea Extract, 4gm, once a day, orally for one day. |
| Intervention |
Turmeric Extract 95% |
Turmeric Extract, 4gm, once a day, orally for one day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1.Subjects must be healthy human male subjects.
2.Age should be between 18-40 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. They must be healthy as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 21 days prior to the commencement of the study.
5.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 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 |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
To determine the bioavailability of curcumin in respective Curcuminoid based formulations.
|
0:00, 0:25, 0:50, 0:75, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24hrs. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of this study is to monitor the safety and tolerability of a single dose of curcumin formulations in 28 healthy human adult male subjects, under fasting conditions. |
Day 0 and Final day |
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Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
03/05/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
None Yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Randomised, pilot, double blind,one period, four arm bioavailability studies is considered to be of the highest standards for assessment of efficacy and safety of a study
medication; accordingly the same design has been used for this study. Healthy volunteers to will be
recruited to this study. This will be accomplished by conducting Laboratory test and physical
examination by the Principal Investigator. Once all the parameters are found to be normal the
subjects will be recruited to this study. This will be 1 period, 1 arm study. The volunteers will be admitted in the facility 11 hours
prior to dosing and will leave the facility 24 hours after the dosing.
The objective of this study is to determine the bioavailability of curcummin in respective curcuminoid based formulations in 28 healthy human adults male subjects under fasting conditions and
also to monitor the safety and tolerability of a single dose of curcummin formulations.
Type of study: Randomised, pilot, double blind, one period, four arm bioavailability study.
Study groups
Group І –Turmeric Extract 95%
Group II –Sustential Curcumin powder
Group III –Curcuminoid-Green tea extract formulation Group IV –Curcumin Powder
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