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Trial Title:
Effect of Carum Carvi on Thyroid Hormones and TSH Level
NCT ID:
NCT01471288
Condition:
Thyroid Cancer Patients
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
well differentiated thyroid cancer
Carum Carvi
Normal controls
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Carum Cravi
Description:
40mg/kg of body weight
Arm group label:
Group 1
Arm group label:
Group3
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Group2
Arm group label:
Group4
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18-65
- Hypothyroid patients under treatment with levothyroxin
- Normal euthyroid patients with no goiter
Exclusion Criteria:
- Pregnancy or lactation
- Severe lung or gasterointestinal disease
- Heart failure or renal failure
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Nuclear Medicine Department, Ghaem Hospital
Address:
City:
Mashhad
Country:
Iran, Islamic Republic of
Status:
Recruiting
Investigator:
Last name:
Zohre Mousavi, MD,IBE
Email:
Sub-Investigator
Investigator:
Last name:
Fateme Khani
Email:
Sub-Investigator
Investigator:
Last name:
Maryam Naghibi
Email:
Sub-Investigator
Start date:
May 2011
Lead sponsor:
Agency:
Mashhad University of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Pharmaceutical Research Center
Agency class:
Other
Source:
Mashhad University of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on April 10, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01471288