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Trial record 36 of 163 for:    curcumin

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
Information provided by (Responsible Party):
Daniel Doberer, Medical University of Vienna

Brief Summary:
Heme oxygenase 1 (HO-1) serves as a protective gene. Induction of HO-1 has therapeutic potential for several indications. The inducibility of HO-1 by curcumin will be evaluated in this pilot study. Furthermore, the influence of a modulating factor of HO-1 gene activity on the dinucleotide guanosine thymine repeat (GT) length polymorphism in the promotor region will be investigated.

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
Primary Completion Date : July 2009
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:
  • Curcumin C3 Complex caplets containing:
  • 1000 mg curcumin and 5 mg bioperine
  • Lot. Nr.: #BA 08072227

Primary Outcome Measures :
  1. The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs [ Time Frame: 48 hrs ]

Secondary Outcome Measures :
  1. Increase of plasma bilirubin level [ Time Frame: 48 hrs ]

Information from the National Library of Medicine

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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.

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): NCT00895167

Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Daniel Doberer

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:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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