Effect of Carum Carvi on Thyroid Hormones and TSH Level

November 14, 2011 updated by: Mashhad University of Medical Sciences

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group3
Normal controls
Drug: Carum Cravi
40mg/kg of body weight
Placebo Comparator: Group4
Normal controls
Drug: Placebo
Placebo
Active Comparator: Group 1
Hypothyroid patients taking levothyroxin.
Drug: Carum Cravi
40mg/kg of body weight
Placebo Comparator: Group2
Hypothyroid patients taking levothyroxin
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-2-6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of hypothyroidism index from baseline at 2 and 6 weeks
Time Frame: 0,2 and 6 weeks
Hypothyroidism Index
0,2 and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Collaborators

Pharmaceutical Research Center

Investigators

  • Principal Investigator: Seyed Rasoul Zakavi, MD. IBNM, Nuclear Medicine Research Center
  • Principal Investigator: Mohammad Ramezani, Ph.D., Pharm.D, Pharmaceutical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 15, 2011

Study Record Updates

Last Update Posted (Estimate)

November 15, 2011

Last Update Submitted That Met QC Criteria

November 14, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88498

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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