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Turmeric Effect on Reduction of Serum Prolactin and Related Hormonal Change and Adenoma Size in Prolactinoma Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Haleh Rokni Yazdi, Mashhad University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344291
First Posted: April 29, 2011
Last Update Posted: November 1, 2011
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.
Information provided by (Responsible Party):
Haleh Rokni Yazdi, Mashhad University of Medical Sciences
  Purpose
Prolactinoma is the most prevalent anterior hypophysis tumor. The principal treatment for this disorder is Dopamine agonist drugs including bromocriptin and Cabergoline. However, 50% of Bromocriptin treated and 17% of Cabergoline treated patients are resistant to these drugs. Curcumin is the main derivative of turmeric ,an old spice which is used frequently in Indian and Iranian cuisine. It has been proved that curcumin can reduce mammotrope cells proliferation and also intracellular hormone production. The purpose of this study is to evaluate the effect of turmeric on prolactinoma patients.

Condition Intervention Phase
Hyperprolactinoma Drug: Curcumin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Haleh Rokni Yazdi, Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • serum prolactin level [ Time Frame: 2weeks and one month after treatment ]

Secondary Outcome Measures:
  • change in LH,FSH and estradiol from baseline [ Time Frame: one month ofter treatment ]

Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Curcumin
    Curcumin is prescribed to new cases of hyperprolactinoma
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hyperprolactinemia
  • microprolactinoma

Exclusion Criteria:

  • pregnancy
  • macroadenoma
  • neurologic signs due to tumor
  Contacts and Locations
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): NCT01344291


Contacts
Contact: haleh rokni, proffessore assisstant 00981082976 roknih@mums.ac.ir

Locations
Iran, Islamic Republic of
Mashad University of Medical Sciences Recruiting
Mashad, Khorasan Razavi, Iran, Islamic Republic of
Contact: haleh rokni    00985118012976    roknih@mums.ac.ir   
Sponsors and Collaborators
Mashhad University of Medical Sciences
  More Information

Responsible Party: Haleh Rokni Yazdi, assisstant professor, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01344291     History of Changes
Other Study ID Numbers: Turmeric-01
First Submitted: April 18, 2011
First Posted: April 29, 2011
Last Update Posted: November 1, 2011
Last Verified: October 2011

Keywords provided by Haleh Rokni Yazdi, Mashhad University of Medical Sciences:
hyperprolactinoma
turmeric
amenorrhea

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