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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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.
-
Comments
-