NCT01344291

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

April 18, 2011

Last Update Submit

October 29, 2011

Conditions

Keywords

hyperprolactinomaturmericamenorrhea

Outcome Measures

Primary Outcomes (1)

  • serum prolactin level

    2weeks and one month after treatment

Secondary Outcomes (1)

  • change in LH,FSH and estradiol from baseline

    one month ofter treatment

Interventions

Curcumin is prescribed to new cases of hyperprolactinoma

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • hyperprolactinemia
  • microprolactinoma

You may not qualify if:

  • pregnancy
  • macroadenoma
  • neurologic signs due to tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashad University of Medical Sciences

Mashhad, Khorasan Razavi, Iran

RECRUITING

MeSH Terms

Conditions

Amenorrhea

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Central Study Contacts

haleh rokni, proffessore assisstant

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 29, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations