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Effect of Carum Carvi on Thyroid Hormones and TSH Level

Primary Purpose

Thyroid Cancer Patients

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Carum Cravi
Placebo
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Thyroid Cancer Patients focused on measuring well differentiated thyroid cancer, Carum Carvi, Normal controls

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nuclear Medicine Department, Ghaem HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Group3

Group4

Group 1

Group2

Arm Description

Normal controls

Normal controls

Hypothyroid patients taking levothyroxin.

Hypothyroid patients taking levothyroxin

Outcomes

Primary Outcome Measures

Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks
TSH, Free T4, Free T3, T4RIA and T3RIA

Secondary Outcome Measures

Change of hypothyroidism index from baseline at 2 and 6 weeks
Hypothyroidism Index

Full Information

First Posted
July 21, 2011
Last Updated
November 14, 2011
Sponsor
Mashhad University of Medical Sciences
Collaborators
Pharmaceutical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01471288
Brief Title
Effect of Carum Carvi on Thyroid Hormones and TSH Level
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 Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mashhad University of Medical Sciences
Collaborators
Pharmaceutical Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer Patients
Keywords
well differentiated thyroid cancer, Carum Carvi, Normal controls

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group3
Arm Type
Active Comparator
Arm Description
Normal controls
Arm Title
Group4
Arm Type
Placebo Comparator
Arm Description
Normal controls
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Hypothyroid patients taking levothyroxin.
Arm Title
Group2
Arm Type
Placebo Comparator
Arm Description
Hypothyroid patients taking levothyroxin
Intervention Type
Drug
Intervention Name(s)
Carum Cravi
Intervention Description
40mg/kg of body weight
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks
Description
TSH, Free T4, Free T3, T4RIA and T3RIA
Time Frame
0-2-6 Weeks
Secondary Outcome Measure Information:
Title
Change of hypothyroidism index from baseline at 2 and 6 weeks
Description
Hypothyroidism Index
Time Frame
0,2 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyed Rasoul Zakavi, MD,IBNM
Phone
+98-511-8022729
Email
zakavir@mums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Zohre Mousavi, MD, IBE
Phone
+98-8599359
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyed Rasoul Zakavi, MD. IBNM
Organizational Affiliation
Nuclear Medicine Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Ramezani, Ph.D., Pharm.D
Organizational Affiliation
Pharmaceutical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nuclear Medicine Department, Ghaem Hospital
City
Mashhad
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zohre Mousavi, MD,IBE
First Name & Middle Initial & Last Name & Degree
Fateme Khani
First Name & Middle Initial & Last Name & Degree
Maryam Naghibi

12. IPD Sharing Statement

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Effect of Carum Carvi on Thyroid Hormones and TSH Level

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