The effect of hydroalcoholic extract of Illicium verum on serum levels of thyroid hormones and stress oxidative index in patients with hypothyroidism: a double-blind randomized clinical trial
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Primary outcomes
#1
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Depression Anxiety and Stress
Depression Anxiety and Stress
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افسردگی، اضطراب و استرس
افسردگی، اضطراب و استرس
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Before the intervention and after the intervention
Before the intervention and after the intervention
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قبل از شروع مداخله و بعد از اتمام مداخله
قبل از شروع مداخله و بعد از اتمام مداخله
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Depression Anxiety and Stress Scale (DASS-21)
Depression Anxiety and Stress Scale (DASS-21)
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پرسشنامه افسردگی، اضطراب واسترس یا DASS-21
پرسشنامه افسردگی، اضطراب واسترس یا DASS-21
Protocol summary
Study aim
Determination of Illicium verum supplement effect on serum levels of thyroid hormones and oxidative stress status in patients with hypothyroidism
Design
In this clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3, forty-four patients with hypothyroidism who meet the inclusion criteria and referred to the specialized clinic of Qazvin University of Medical Sciences, are selected. Participants are randomly divided into intervention and control groups using random blocks and a code is assigned to each participant.
Settings and conduct
The aim of this study is to determine the effectiveness of the hydroalcoholic extract of Illicium verum supplement as a randomized double-blind clinical trial on patients with hypothyroidism referred to the specialized department of Qazvin University of Medical Sciences. The subjects in the intervention and control groups will receive Illicium verum supplements or a placebo for 2 months. At the beginning and end of the study, 10 ml of blood samples were taken from the participants in the fasting state. In this study, participants and the researcher will be blind to being placed in groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patients who are 20-50 years old diagnosed with hypothyroidism; BMI less than 30, Signed informed consent by the patient. Exclusion criteria: Pregnancy; lactation; menopause; infectious disease; inflammatory disease; diabetes and cancer; taking antioxidant supplements over the past three months; drug use over the past three months including diabetes, glucocorticoids, lipid-lowering, and weight-loss drugs
Intervention groups
Intervention group: the group receiving an alcoholic extract of Illicium verum (1500 mg daily).
Control group: the group receiving placebo.
Main outcome variables
Thyroid hormones include thyroxine, triiodothyronine, and thyroid-stimulating hormone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141025019669N19
Registration date:2021-09-24, 1400/07/02
Registration timing:prospective
Last update:2021-11-14, 1400/08/23
Update count:1
Registration date
2021-09-24, 1400/07/02
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2021-10-27, 1400/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydroalcoholic extract of Illicium verum on serum levels of thyroid hormones and stress oxidative index in patients with hypothyroidism: a double-blind randomized clinical trial
Public title
Illicium verum supplementation in patients with hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hypothyroidism
Patient 20-50 years old
Having a body mass index less than 30
Consent signed by the patient
Exclusion criteria:
Pregnancy and lactation
Infectious diseases, Inflammatory diseases, Diabetes, Cancer
Taking antioxidant supplements in the last three months
Drug use over the past three months, including diabetes, glucocorticoids, lipid-lowering drugs, and weight-loss drugs
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done randomly using the lottery method. Each patient will receive a number or code, and then we will write the numbers on pieces of paper. We will then place the pieces of paper in a container and select the samples according to the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebo will be placed in similar containers and encode by someone except the investigator, so patients and the investigator will be blinded to medicine and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University Of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2021-09-07, 1400/06/16
Ethics committee reference number
IR.QUMS.REC.1400.249
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E03
ICD-10 code description
Other hypothyroidism
Primary outcomes
1
Description
Thyroxine hormone
Timepoint
Before the intervention and after the intervention
Method of measurement
ELISA
2
Description
Triiodothyronine hormone
Timepoint
Before the intervention and after the intervention
Method of measurement
ELISA
3
Description
Thyroid-stimulating hormone
Timepoint
Before the intervention and after the intervention
Method of measurement
ELISA
4
Description
Total antioxidant capacity
Timepoint
Before the intervention and after the intervention
Method of measurement
ELISA
5
Description
Malondialdehyde
Timepoint
Before the intervention and after the intervention
Method of measurement
ELISA
6
Description
Depression Anxiety and Stress
Timepoint
Before the intervention and after the intervention
Method of measurement
Depression Anxiety and Stress Scale (DASS-21)
Secondary outcomes
1
Description
Body mass index
Timepoint
Before the intervention and after the intervention
Method of measurement
Using the formula (weight in kilograms divided by height in meters squared)
Intervention groups
1
Description
Intervention group: Hydroalcoholic extract of Illicium verum, Three 500 mg capsules per day for two months
Category
Treatment - Drugs
2
Description
Control group: Three placebo capsules containing wheat flour daily for two months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Hossein Khadem Haghighian
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyyed Mehdi Mirhashemi
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after people are unrecognizable
When the data will become available and for how long
After completing the study and publishing the article
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is nothing wrong with using the data as long as the source of the data is mentioned.
From where data/document is obtainable
By contacting the email address of a person responsible for general inquiries khademnut@yahoo.com
What processes are involved for a request to access data/document
After consulting with the research team, the data will be provided to the applicant, which will probably be a one-month process.