CTRI/2025/07/091556 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On:
21/07/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Use of Curcumin in healthy adults under fasting conditions.
Scientific Title of Study
An Open Label, Randomized, Balanced, Four-Treatment, Four-Sequence, Four-Period, Four-way
cross-over, Single Oral dose comparative bioavailability study of Curcumin in healthy human
subjects under fasting conditions.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
061-25
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sanjay Vaze
Designation
Principal Investigator
Affiliation
VEDIC LIFESCIENCES PVT LTD
Address
Vedic Lifesciences Pvt. LTD 203, Morya Landmark 1, Off New Link Road, Andheri West, Mumbai,
MAHARASHTRA - 400053, India.
Mumbai (Suburban) MAHARASHTRA 400053 India
Phone
8655670964
Fax
Email
sanjay.v@vediclifesciences.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Vaze
Designation
Principal Investigator
Affiliation
VEDIC LIFESCIENCES PVT LTD
Address
Vedic Lifesciences Pvt. LTD 203, Morya Landmark 1, Off New Link Road, Andheri West, Mumbai,
MAHARASHTRA - 400053, India.
Mumbai (Suburban) MAHARASHTRA 400053 India
Phone
8655670964
Fax
Email
sanjay.v@vediclifesciences.com
Details of Contact Person Public Query
Name
Pooja Gorule
Designation
Senior Project Executive
Affiliation
VEDIC LIFESCIENCES PVT LTD
Address
Vedic Lifesciences Pvt. LTD 203, Morya Landmark 1, Off New Link Road, Andheri West, Mumbai,
MAHARASHTRA - 400053, India.
Mumbai (Suburban) MAHARASHTRA 400053 India
Phone
8655728947
Fax
Email
pooja.g@vediclifesciences.com
Source of Monetary or Material Support
Vedic Lifesciences PVT LTD
Primary Sponsor
Name
Vedic Lifesciences Pvt. Ltd
Address
203, Morya Landmark 1, Off New Link Road, AndheriWest, Mumbai, MAHARASHTRA - 400053, India.
Type of Sponsor
Contract research organization
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 Sanjay Vaze
IndiGlobal Labs Pvt. Ltd.
Plot no.7, CF Area, IDA, Phase II, Cherlapally, Hyderabad-500051, Telangana, India Hyderabad TELANGANA
7207318468
info@indigloballabs.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Maarg Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Fasting Condition
Intervention / Comparator Agent
Type
Name
Details
Intervention
Curcumin Dispersome formulation
75% BLG (600 mg (2 capsules of 300
mg each, containing 90 mg curcumin per capsule
Intervention
Non-formulated Curcumin
(dose: 90 mg, 1 capsule
Comparator Agent
Benchmark Formulation 1 - Turmipure Gold™
recommended daily dose:
300 mg, 1 capsule
Comparator Agent
Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra
Strength
recommended daily dose: 1000 mg, 2 capsules of 500 mg each
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
9.5.1 Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form
9.5.2 Age greater than equal to 18 less than equal to 45 years.
9.5.3 Willing to consume the study product and donate blood.
9.5.4 BMI from 18.5 to 29.9 kg/m².
9.5.5 Subject with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable limits.
9.5.6 Subjects having vital parameters (blood pressure, body temperature, pulse rate and respiratory rate) within acceptable limits.
9.5.7 Non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day, and willing to abstain from smoking or chewing any tobacco containing products at least 72.00 hours prior to check-in and throughout the sampling points.
9.5.8 Agreeing not to consume food, drink and condiment containing curcumin (e.g. curry), or other curcuminoids (DMC, BDMC) for the whole duration of the study (36 hours pre-dose to 24 hours post-dose in each period).
9.5.9 Good general and mental health in the opinion of the investigator: no clinically significant or
relevant abnormalities upon review of medical history or following a physical examination
prior to check-in.
9.5.10 If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence Or She is surgically sterile (had a bilateral tubal ligation, bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 06 months).
ExclusionCriteria
Details
9.6.1 Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract or may affect absorption of IP and blood forming organ.
9.6.2 Significant history or current evidence of malignancy or chronic – infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric disease or organ dysfunction.
9.6.3 Any major illness or hospitalization within 90 days prior to first admission to the study.
9.6.4 Use of any depot injection or an implant of any drug within 3 months prior to check-in and
throughout the study.
9.6.5 Use of any prescribed medication or OTC (including herbal drugs and vitamin supplements)
within 14 days prior to check-in and throughout the study.
9.6.6 Use of botanical dietary supplements during the study or within three months prior to check-in.
9.6.7 Difficulty in swallowing capsules.
9.6.8 History or presence of alcohol abuse in the past one year [Alcohol abuse will be defined as greater than 14 drinks per week (1 drink equal to 360 mL beer, 150 mL wine, or 45 mL hard liquor)].
9.6.9 Consumption of alcoholic products within 24.00 hours prior to check-in in each study period and throughout sampling time points.
9.6.10 Positive alcohol breath or urine drug of abuse test during check-in on each study period.
9.6.11 Consumption of xanthine’s or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 48.00 hours prior to check-in and throughout sampling time points.
9.6.12 Consumption of grapefruit or its juice within 72.00 hours prior to check-in in each period and throughout sampling time points.
9.6.13 History of allergy or hypersensitivity intolerance to turmeric or curcumin.
9.6.14 Individuals who, in the opinion of the investigator, are unlikely to be able to comply with the study.
9.6.15 Irritable bowel syndrome.
9.6.16 Current disease states that are contraindicated with dietary supplementation: chronic diarrhea, constipation or abdominal pain, chronic laxatives use.
9.6.17 Pathology which could affect the study results or expose the subject to an additional risk according to the investigator.
9.6.18 Recent gastroenteritis or food borne illness such as confirmed food poisoning (less than 1 month).
9.6.19 Blood donation within 90 Days prior to the initial visit or intending to donate within the next 90 Days.
9.6.20 Low venous capital not allowing blood kinetic sampling.
9.6.21 Known or suspected food allergy, intolerance, or hypersensitivity to any of the study product ingredients and/or of the standard meals (gluten intolerance, celiac disease, etc.)
9.6.22 Chronic drug treatment (for example anticoagulant, antihypertensive medication, thyroid
treatment, asthma treatment, anxiolytic, antidepressant, lipid-lowering treatment, corticosteroids, phlebotonic, veino-tonic, drug with impact on blood circulation) excluding oral and local contraceptives.
9.6.23 Currently taking (or during the past 3 months) any botanical dietary supplement.
9.6.24 History of anorexia nervosa, bulimia, or significant eating disorders according to the investigator.
9.6.25 Participation in another clinical trial 90 days prior to check-in period I of this study.
9.6.26 Presenting a psychological or linguistic incapability to sign the informed consent.
9.6.27 Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 06 months prior to check-in or used hormonal contraceptives within 14 days before check-in
9.6.28 Female volunteer who demonstrates a positive urine pregnancy test at prior to check-in and any time during the study
9.6.29 Each female study volunteer will be screened for urine pregnancy test at screening and at the check-in in each study period. Study volunteer with a positive or inconclusive result will be withdrawn from the study
9.6.30 Female volunteer who is currently breast feeding.
9.6.31 Female study volunteer who is pregnant, breast-feeding or who is likely to become pregnant during the study will not be allowed to participate. Female study volunteer of child bearing potential must either agree to abstain from sexual intercourse or use 2 reliable methods of contraception (e.g. condom, IUD) during the course of the study (first dosing until last blood collection) or she will not be allowed to participate.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To assess comparative bioavailability of investigational products when compared with benchmark products, when administered to healthy, adult, human subjects under fasting conditions.
Pre-dose at -1.00 and 0.00 (within 10 minutes prior to dosing) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00 and 24.00 hours post-dose.
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of Curcumin when administered to healthy, adult, human subjects under fasting conditions.
Pre-dose at -1.00 and 0.00 (within 10 minutes prior to dosing) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00 and 24.00 hours post-dose.
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="24"
Phase of Trial
N/A
Date of First Enrollment (India)
15/09/2025
Date of Study Completion (India)
07/10/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The sponsor has developed new curcuminoid formulations with the expectation of enhanced
bioavailability compared to existing benchmark products. This study aims to evaluate the
comparative bioavailability and characterize the pharmacokinetic profile of the test formulations
in comparison to the reference formulations in healthy adult subjects under fasting conditions.