Protocol summary

Summary
The aim of this randomized, placebo-controlled trial is to investigate the effects of Nigella sativa powder on serum Levels of Thyroid Hormones, Beta Transforming Growth Factor, Interleukin 23, lipid profile and markers of oxidative stress in Hashimoto’s Thyroiditis patients. Forty Hashimoto’s Thyroiditis patients that their disease was confirmed by pathological assessment will be enrolled in this study according inclusion and exclusion criteria. The participants will be assigned into control and treatment groups using permuted-blocks randomization and will be studied in Double-Blind way. Treatment group will receive 2 gram of Nigella sativa powder daily and Placebo Group will receive 2 gram of starch daily along with their lunch and dinner meals for 8 weeks. demographic information, Physical Activity, and 24-hour recall Questionnaire will be completed before and 2 month after the intervention. Blood Samples (7CC) will be taken before and after the intervention and will be kept under -70 Celsius for the relevant tests.Related biochemical measurements will be done by Elisa Kits.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014090819082N2
Registration date: 2014-09-29, 1393/07/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Mahdieh Abbasalizad Farhangi
Name of organization / entity
Department of Community Nutrition School of Nutrition
Country
Iran (Islamic Republic of)
Phone
+98 413357580
Email address
abbasalizadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
compare the effect of Nigella Sativa powder in the supplement group and placebo on the Serum Levels of Thyroid Hormones, Beta Transforming Growth Factor, Interlukin 23, Lipid Pattern and markers of oxidative stress in Hashimoto’s Thyroiditis patients
Public title
The Effect of oral consumption of Nigella Sativa in the treatment of autoimmune Hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age Range of 20-50; Suffering from Hashimoto disease with the Diagnosis of Physician based on specialized Tests; Completing Informed Consent Form. Exclusion Criteria: not signed informed consent Form; physiologic Special conditions such as pregnancy and breast-feeding; receiving supplements such as Vitamin E, C, Zinc, Folat, Cobalamin, Soy fitoestrogens in the last 3 month; suffering from any auotoimmune disease; history of thyroid operation, following any special diet
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
None
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golbad Street, Tabriz, East Azerbayjan, Iran
City
Tabriz
Postal code
Approval date
2014-08-04, 1393/05/13
Ethics committee reference number
9369

Health conditions studied

1

Description of health condition studied
Hashimoto’s Thyroiditis
ICD-10 code
E06.3
ICD-10 code description
Autoimmune thyroiditis

Primary outcomes

1

Description
Serum concentration ofIL-23
Timepoint
At baseline and after 2 months of intervention
Method of measurement
ELISA

2

Description
Serum concentration ofTGF-β
Timepoint
At baseline and after 2 months of intervention
Method of measurement
ELISA

3

Description
Serum concentration ofT4, T3، TSH،TPOAb
Timepoint
At baseline and after 2 months of intervention
Method of measurement
ELISA

4

Description
Serum concentration ofT4, T3، TSH،TPOAb
Timepoint
At baseline and after 2 months of intervention
Method of measurement
ELISA

5

Description
Added at 2017-02-12: Serum Concentrations of MDA, GPX, SOD and TAC
Timepoint
Added at 2017-02-12: Before and after intervention
Method of measurement
Added at 2017-02-12: ELIZA

6

Description
Added at 2017-02-12: Serum TAC
Timepoint
Added at 2017-02-12: At baseline and after 2 months of intervention
Method of measurement
Added at 2017-02-12: ELIZA

7

Description
Added at 2017-02-12: Serum CAT
Timepoint
Added at 2017-02-12: At baseline and after 2 months of intervention
Method of measurement
Added at 2017-02-12: ELIZA

8

Description
Added at 2017-02-12: Serum GPX
Timepoint
Added at 2017-02-12: At baseline and after 2 months of intervention
Method of measurement
Added at 2017-02-12: ELIZA

9

Description
Added at 2017-02-12: Serum SOD
Timepoint
Added at 2017-02-12: At baseline and after 2 months of intervention
Method of measurement
Added at 2017-02-12: ELISA

Secondary outcomes

1

Description
Physical Activity
Timepoint
At baseline and after 2 months of intervention
Method of measurement
Physical Activity Questionare

2

Description
Receiving Energy and Macronutrients
Timepoint
Before The first month termination and after the eight week
Method of measurement
24-hour memorial questionare

3

Description
BMI
Timepoint
At baseline and after 2 months of intervention
Method of measurement
Weight divided by Height Square

Intervention groups

1

Description
Nigella sativa group will receive 2 gram of Nigella sativa powder in the form of 1 gram packs with lunch and dinner meals for 8 weeks.The supplement will be given weekly and during the consumption possible side effects and keeping on consumption will be monitored
Category
Treatment - Drugs

2

Description
Placebo group will receive 2 gram of starch in the form of 1-gram packs with lunch and dinner meals weekly for 8 weeks and during the consumption possible side effects and keeping on consumption will be monitored
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Sedieghe Tahereh Endocrinology and Metabolism Research Centre
Full name of responsible person
Dr. Mansoor Siavashi
Street address
Esfahant Sedieghe Tahereh Endocrinology and Metabolism Research Centre, Khorram St. Isfahan
City

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Golbad Street, Tabriz, East Azerbayjan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sirus Tajmiri
Position
MSc student in health sciences in nutrition
Other areas of specialty/work
Street address
Attar Neishabouri Street, Golgasht Street, Tabriz, East Azerbaijan, Islamic Republic Of Iran
City
Tabriz
Postal code
Phone
+98 910 515 0752
Fax
Email
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdieh Abbasalizadeh Farhangi
Position
Assistant professor
Other areas of specialty/work
Street address
Attar Neishabouri Street, Golgasht Street, Tabriz, East Azerbaijan
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
abbasalizadm@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Siros Tajmiri
Position
MSc student in health sciences in nutrition
Other areas of specialty/work
Street address
Attar St., Golgasht St., Tabriz, East Azerbaijan
City
Tabriz
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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