Turmeric Effect on Reduction of Serum Prolactin and Related Hormonal Change and Adenoma Size in Prolactinoma Patients
This study is currently recruiting participants.
Verified October 2011 by Mashhad University of Medical Sciences
Sponsor:
Mashhad University of Medical Sciences
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
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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
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 |
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 Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013