Thyroid Cancer PatientsPhase 1/2NCT01471288
Effect of Carum Carvi on Thyroid Hormones and TSH Level
A Phase 1/2 study testing Carum Cravi in people with Thyroid Cancer Patients, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer Patients
- What is being tested?
- Carum Cravi
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Hypothyroid patients under treatment with levothyroxin
- Normal euthyroid patients with no goiter
Who cannot join
- Pregnancy or lactation
- Severe lung or gasterointestinal disease
- Heart failure or renal failure
Trial locations and contacts
1 site in 1 country.
Zohre Mousavi, MD, IBE contact
Iran1 site, 1 recruiting
- Recruiting
Nuclear Medicine Department, Ghaem Hospital
Mashhad
Zohre Mousavi, MD,IBE
Fateme Khani
About this study
Official title: Evaluation of the Effect of Carum Carvi on Levels of Plasma Thyroid Hormones and TSH Level in Patients on Thyroid Hormone Therapy and Normal Controls.
Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin. TSH level returned to normal after discontinuation of the Carum carvi. This observation led to a pilot study for evaluation of the effect of carum carvi on thyroid function.
- Conditions
- Thyroid Cancer Patients
- Being tested
- Carum Cravi, Placebo
- Keywords
- well differentiated thyroid cancer, Carum Carvi, Normal controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carum CraviDrug
40mg/kg of body weight
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group3 | Active comparator | Normal controls Receives: Drug: Carum Cravi |
| Group4 | Placebo comparator | Normal controls Receives: Drug: Placebo |
| Group 1 | Active comparator | Hypothyroid patients taking levothyroxin. Receives: Drug: Carum Cravi |
| Group2 | Placebo comparator | Hypothyroid patients taking levothyroxin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks
TSH, Free T4, Free T3, T4RIA and T3RIA
Measured: 0-2-6 Weeks
Secondary outcomes (1)
Change of hypothyroidism index from baseline at 2 and 6 weeks
Hypothyroidism Index
Measured: 0,2 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Cancer PatientsStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmaceutical Research Center
- Investigators
- Seyed Rasoul Zakavi, MD. IBNM, Principal investigator, Nuclear Medicine Research CenterMohammad Ramezani, Ph.D., Pharm.D, Principal investigator, Pharmaceutical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471288
- Sponsor's protocol ID
- 88498
- Status last verified
- Oct 2011
- First submitted
- 21 Jul 2011
- Last updated
- 15 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Carum Carvi on Levels of Plasma Thyroid Hormones and TSH Level in Patients on Thyroid Hormone Therapy and Normal Controls.
- ClinicalTrials.gov ID
- NCT01471288
- Acronym / sponsor ID
- 88498
- Conditions
- Thyroid Cancer Patients
- Keywords
- well differentiated thyroid cancer, Carum Carvi, Normal controls
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Collaborators
- Pharmaceutical Research Center
- Study start
- May 2011
- Primary completion
- Dec 2011 (estimated)
- First posted
- 15 Nov 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.
Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin. TSH level returned to normal after discontinuation of the Carum carvi. This observation led to a pilot study for evaluation of the effect of carum carvi on thyroid function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group3 | Active comparator | Drug: Carum CraviNormal controls |
| Group4 | Placebo comparator | Drug: PlaceboNormal controls |
| Group 1 | Active comparator | Drug: Carum CraviHypothyroid patients taking levothyroxin. |
| Group2 | Placebo comparator | Drug: PlaceboHypothyroid patients taking levothyroxin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65
- Hypothyroid patients under treatment with levothyroxin
- Normal euthyroid patients with no goiter
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- Severe lung or gasterointestinal disease
- Heart failure or renal failure
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 |
|---|---|---|
| Carum Cravi40mg/kg of body weight | Drug | Group 1, Group3 |
| PlaceboPlacebo | Drug | Group2, Group4 |
Primary outcome
Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks
Time frame: 0-2-6 Weeks
TSH, Free T4, Free T3, T4RIA and T3RIA
1 secondary outcome
Change of hypothyroidism index from baseline at 2 and 6 weeks
Time frame: 0,2 and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2011.
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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.
Zohre Mousavi, MD, IBE contact
Seyed Rasoul Zakavi, MD. IBNM principal investigator
Nuclear Medicine Research Center
Mohammad Ramezani, Ph.D., Pharm.D principal investigator
Pharmaceutical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Carum Cravi in people with Thyroid Cancer Patients, 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 3 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 15 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Seyed Rasoul Zakavi, MD,IBNM (+98-511-8022729, zakavir@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks (time frame: 0-2-6 Weeks). 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 15 Nov 2011.