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 because the information has not been verified recently.
Verified October 2011 by Mashhad University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Haleh Rokni Yazdi, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01344291
First received: April 18, 2011
Last updated: October 29, 2011
Last verified: October 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • serum prolactin level [ Time Frame: 2weeks and one month after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in LH,FSH and estradiol from baseline [ Time Frame: one month ofter treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 18, 2011
Last Updated: October 29, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:
hyperprolactinoma
turmeric
amenorrhea

ClinicalTrials.gov processed this record on October 19, 2014