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Bio-availability of a New Liquid Tumeric Extract

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ClinicalTrials.gov Identifier: NCT00542711
Recruitment Status : Withdrawn (Technical difficulties)
First Posted : October 11, 2007
Last Update Posted : August 20, 2015
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
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Brief Summary:
Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The current available curcumin has low bioavailability restricting the effect of curcumin in non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract, Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the bioavailability of the liquid tumeric/curcumin extract will be better compared to the currently used curcumin powder.

Condition or disease Intervention/treatment Phase
Healthy Drug: liquid tumeric/curcumin extract Phase 1

Detailed Description:
Twelve healthy participants enrolled to the study. All volunteers will have pre study evaluation to confirm healthy state. After enrollment, each participant will be tested twice, one with the liquid tumeric/curcumin (study drug) and once with the curcumin powder (control). The days of testing will be on two days, separated by two weeks wash-out period. The participants will be assigned to randomly receive study drug or control on the 1st day, with the other regimen administered at the 2nd day. Both study drug and control will be diluted in 150ml of water. The doe of study drug will be escalated from 30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). Blood sample will be collected at 0,0.25,0.5,0.75,1,2,3,4,5,6,8h post drug. Quantization of curcumin plasma levels will be done by the high pressure liquid chormatography method. A biomarker for the potential effect of curcumin, platelet function pre and post curcumin consumption will be tested.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liquid Tumeric Extract for Increasing Bio-availability of Curcumin in the Human Body: Pharmacokinetic Study.

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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Intervention Details:
  • Drug: liquid tumeric/curcumin extract
    30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). one dose.
    Other Name: Curcumol (patent pending, Israel Patent Application No. 181,121).

Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Complete Healthy
  • Able to attend two full days of study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542711


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Shoshana Revel-Vilk, MD Hadassah Medical Organization
More Information
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00542711    
Other Study ID Numbers: Curcumol-HMO-CTIL
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015
Keywords provided by Hadassah Medical Organization:
Curcumin
Bioavilability
Healthy subjects
Additional relevant MeSH terms:
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Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action