The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects (CUMAHS)
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ClinicalTrials.gov Identifier: NCT00895167 |
Recruitment Status
:
Completed
First Posted
: May 8, 2009
Last Update Posted
: January 17, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Dietary Supplement: curcumin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | August 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: curcumin
every subject receives 12 g of oral curcumin
|
Dietary Supplement: curcumin
one oral dose of 12 caplets = 12 g curcumin
Other Names:
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- The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs [ Time Frame: 48 hrs ]
- Increase of plasma bilirubin level [ Time Frame: 48 hrs ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure.
- Male patient aged between 18 and 45 years (inclusive) at screening.
- No clinically significant findings on the physical examination at screening.
- Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
- 12-lead ECG without clinically relevant abnormalities at screening.
- Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
- Negative results from urine drug screen at screening.
- Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
Exclusion Criteria:
- Known hypersensitivity to the study drug or any excipients of the drug formulation.
- Treatment with another investigational drug within 3 weeks prior to screening.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
- Smoking within the last 3 months prior to screening.
- Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
- Regularly intake of curcumin rich food
- Loss of 250 ml or more of blood within 3 months prior to screening.
- Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
- Positive results from the HIV serology at screening.
- Presumed non-compliance.
- Legal incapacity or limited legal capacity at screening.

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): NCT00895167
Austria | |
Medical University of Vienna, Department of Clinical Pharmacology | |
Vienna, Austria, 1090 |
Additional Information:
Responsible Party: | Daniel Doberer, Subinvestigator, Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00895167 History of Changes |
Other Study ID Numbers: |
EudraCT - 2008-004900-30 |
First Posted: | May 8, 2009 Key Record Dates |
Last Update Posted: | January 17, 2013 |
Last Verified: | January 2013 |
Keywords provided by Daniel Doberer, Medical University of Vienna:
Heme Oxygenase Genetic Polymorphism Healthy Subjects |
Additional relevant MeSH terms:
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 |