HyperprolactinomaPhase 1NCT01344291
Turmeric Effect on Reduction of Serum Prolactin and Related Hormonal Change and Adenoma Size in Prolactinoma Patients
A Phase 1 study testing Curcumin in people with Hyperprolactinoma, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Hyperprolactinoma
- What is being tested?
- Curcumin
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Jul 2011to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- hyperprolactinemia
- microprolactinoma
Who cannot join
- pregnancy
- macroadenoma
- neurologic signs due to tumor
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mashad University of Medical Sciences
Mashhad, Razavi Khorasan Province
haleh rokni, 00985118012976, roknih@mums.ac.ir
About this study
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.
- Conditions
- Hyperprolactinoma
- Being tested
- Curcumin
- Keywords
- hyperprolactinoma, turmeric, amenorrhea
- Medical subject headings
- Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Curcumin is prescribed to new cases of hyperprolactinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
serum prolactin level
Measured: 2weeks and one month after treatment
Secondary outcomes (1)
change in LH,FSH and estradiol from baseline
Measured: one month ofter treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperprolactinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haleh Rokni Yazdi, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344291
- Sponsor's protocol ID
- Turmeric-01
- Status last verified
- Oct 2011
- First submitted
- 18 Apr 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turmeric Effect on Reduction of Serum Prolactin and Related Hormonal Change and Adenoma Size in Prolactinoma Patients
- ClinicalTrials.gov ID
- NCT01344291
- Acronym / sponsor ID
- Turmeric-01
- Conditions
- Hyperprolactinoma
- Keywords
- hyperprolactinoma, turmeric, amenorrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- hyperprolactinemia
- microprolactinoma
Key exclusion criteria (3 listed)
- pregnancy
- macroadenoma
- neurologic signs due to tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminCurcumin is prescribed to new cases of hyperprolactinoma | Drug | – |
Primary outcome
serum prolactin level
Time frame: 2weeks and one month after treatment
1 secondary outcome
change in LH,FSH and estradiol from baseline
Time frame: one month ofter treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Curcumin in people with Hyperprolactinoma, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact haleh rokni, proffessore assisstant (00981082976, roknih@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum prolactin level (time frame: 2weeks and one month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2011.