Effect of Carum Carvi on Thyroid Hormones and TSH Level

Thyroid Cancer Patients Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01471288
• Other study ID #: 88498
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 21, 2011
• Last updated: November 14, 2011
• Start date: May 2011

Study information

• Verified date: October 2011
• Source: Mashhad University of Medical Sciences
• Contact: Seyed Rasoul Zakavi, MD,IBNM
• Phone: +98-511-8022729
• Email: zakavir[@]mums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Thyroid Cancer Patients
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Carum Cravi
40mg/kg of body weight
• Placebo
Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Nuclear Medicine Department, Ghaem Hospital	Mashhad

Sponsors (2)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences	Pharmaceutical Research Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks	TSH, Free T4, Free T3, T4RIA and T3RIA	0-2-6 Weeks	Yes
Secondary	Change of hypothyroidism index from baseline at 2 and 6 weeks	Hypothyroidism Index	0,2 and 6 weeks	No