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Effect of Carum Carvi on Thyroid Hormones and TSH Level

Information source: Mashhad University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Cancer Patients

Intervention: Carum Cravi (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Mashhad University of Medical Sciences

Official(s) and/or principal investigator(s):
Seyed Rasoul Zakavi, MD. IBNM, Principal Investigator, Affiliation: Nuclear Medicine Research Center
Mohammad Ramezani, Ph.D., Pharm.D, Principal Investigator, Affiliation: Pharmaceutical Research Center

Overall contact:
Seyed Rasoul Zakavi, MD,IBNM, Phone: +98-511-8022729, Email: zakavir@mums.ac.ir

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks

Secondary outcome: Change of hypothyroidism index from baseline at 2 and 6 weeks

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Seyed Rasoul Zakavi, MD,IBNM, Phone: +98-511-8022729, Email: zakavir@mums.ac.ir

Nuclear Medicine Department, Ghaem Hospital, Mashhad, Iran, Islamic Republic of; Recruiting
Zohre Mousavi, MD,IBE, Sub-Investigator
Fateme Khani, Sub-Investigator
Maryam Naghibi, Sub-Investigator
Additional Information

Starting date: May 2011
Last updated: November 14, 2011

Page last updated: August 23, 2015

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