NCT01471288

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 15, 2011

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

November 15, 2011

Status Verified

October 1, 2011

Enrollment Period

7 months

First QC Date

July 21, 2011

Last Update Submit

November 14, 2011

Conditions

Thyroid Cancer Patients

Keywords

well differentiated thyroid cancerCarum CarviNormal controls

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change of hypothyroidism index from baseline at 2 and 6 weeks

    0,2 and 6 weeks

Study Arms (4)

Group3

ACTIVE COMPARATOR

Normal controls

Drug: Carum Cravi

Group4

PLACEBO COMPARATOR

Normal controls

Drug: Placebo

Group 1

ACTIVE COMPARATOR

Hypothyroid patients taking levothyroxin.

Drug: Carum Cravi

Group2

PLACEBO COMPARATOR

Hypothyroid patients taking levothyroxin

Drug: Placebo

Interventions

Carum CraviDRUG

40mg/kg of body weight

Group 1Group3
PlaceboDRUG

Placebo

Group2Group4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Hypothyroid patients under treatment with levothyroxin
  • Normal euthyroid patients with no goiter

You may not qualify if:

  • Pregnancy or lactation
  • Severe lung or gasterointestinal disease
  • Heart failure or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuclear Medicine Department, Ghaem Hospital

Mashhad, Iran

RECRUITING

Study Officials

  • Seyed Rasoul Zakavi, MD. IBNM

    Nuclear Medicine Research Center

    PRINCIPAL INVESTIGATOR

  • Mohammad Ramezani, Ph.D., Pharm.D

    Pharmaceutical Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyed Rasoul Zakavi, MD,IBNM

CONTACT

+98-511-8022729zakavir@mums.ac.ir

Zohre Mousavi, MD, IBE

CONTACT

+98-8599359

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2011

First Posted

November 15, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Last Updated

November 15, 2011

Record last verified: 2011-10

Locations

IR(1)