Effect of Carum Carvi on Thyroid Hormones and TSH Level

NCT ID: NCT01471288

Last Updated: 2011-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Cancer Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group3

Normal controls

Group Type ACTIVE_COMPARATOR

Carum Cravi

Intervention Type DRUG

40mg/kg of body weight

Group4

Normal controls

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Group 1

Hypothyroid patients taking levothyroxin.

Group Type ACTIVE_COMPARATOR

Carum Cravi

Intervention Type DRUG

40mg/kg of body weight

Group2

Hypothyroid patients taking levothyroxin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Carum Cravi

40mg/kg of body weight

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pharmaceutical Research Center

UNKNOWN

Sponsor Role collaborator

Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Nuclear Medicine Research Center

Principal Investigators

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Seyed Rasoul Zakavi, MD. IBNM

Role: PRINCIPAL_INVESTIGATOR

Nuclear Medicine Research Center

Mohammad Ramezani, Ph.D., Pharm.D

Role: PRINCIPAL_INVESTIGATOR

Pharmaceutical Research Center

Locations

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Nuclear Medicine Department, Ghaem Hospital

Mashhad, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Seyed Rasoul Zakavi, MD,IBNM

Role: CONTACT

+98-511-8022729

Zohre Mousavi, MD, IBE

Role: CONTACT

+98-8599359

Other Identifiers

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88498

Identifier Type: -

Identifier Source: org_study_id