- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01344291
Turmeric Effect on Reduction of Serum Prolactin and Related Hormonal Change and Adenoma Size in Prolactinoma Patients
October 29, 2011 updated by: Haleh Rokni Yazdi, Mashhad University of Medical Sciences
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: haleh rokni, proffessore assisstant
- Phone Number: 00981082976
- Email: roknih@mums.ac.ir
Study Locations
-
-
Khorasan Razavi
-
Mashad, Khorasan Razavi, Iran, Islamic Republic of
- Recruiting
- Mashad University of Medical Sciences
-
Contact:
- haleh rokni
- Phone Number: 00985118012976
- Email: roknih@mums.ac.ir
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- hyperprolactinemia
- microprolactinoma
Exclusion Criteria:
- pregnancy
- macroadenoma
- neurologic signs due to tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum prolactin level
Time Frame: 2weeks and one month after treatment
|
2weeks and one month after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in LH,FSH and estradiol from baseline
Time Frame: one month ofter treatment
|
one month ofter treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
July 1, 2012
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
April 18, 2011
First Submitted That Met QC Criteria
April 27, 2011
First Posted (Estimate)
April 29, 2011
Study Record Updates
Last Update Posted (Estimate)
November 1, 2011
Last Update Submitted That Met QC Criteria
October 29, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- Turmeric-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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