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The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00247026
Recruitment Status : Withdrawn (No funding)
First Posted : November 1, 2005
Last Update Posted : April 11, 2007
Information provided by:
Hadassah Medical Organization

Brief Summary:
To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopenias of patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural compounds curcumin and CoQ10 in MDS because these two agents possess many of the effects that are desirable in MDS.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: curcumin; coenzyme q10 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
Study Start Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. major hematologic improvement in any lineage

Secondary Outcome Measures :
  1. Time to disease progression
  2. Overall and progression-free survival
  3. Cytogenetic response

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • MDS patients with RA, RARS or RAEB will be eligible for treatment with CoQ10 as long as their IPSS score ≤ 1.5.

Exclusion Criteria:

  • Pregnant women and nursing women will be excluded.
  • History of clinically significant liver or kidney disease.
  • ECOG>2
  • IPSS score >1.5
  • Poorly controlled diabetes mellitus, hypertension, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.

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): NCT00247026

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Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: moshe e gatt, dr Hadassah Medical Organization
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ClinicalTrials.gov Identifier: NCT00247026    
Other Study ID Numbers: 385-mds 1-HMO-CTIL
mds 1
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: April 2007
Keywords provided by Hadassah Medical Organization:
coenzyme Q10
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Coenzyme Q10
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