Protocol summary
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Study aim
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Determination of Illicium verum supplement effect on serum levels of thyroid hormones in patients with hypothyroidism
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Design
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In this clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3, twenty 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.
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Settings and conduct
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The aim of this study is to evaluate the aqueous extract of Illicium verum supplement as a randomized, double-blind clinical trial on patients with hypothyroidism referring to the specialized department of the Velayat hospital of Qazvin University of Medical Sciences.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: the patients who are 20-50 years old diagnosed with hypothyroidism; BMI less than 30, Signed informed consent by the patient. Non-inclusion 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
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Intervention groups
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Intervention group: the group receiving an aqueous extract of Illicium verum (1500 mg daily). Control group: the group receiving placebo.
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Main outcome variables
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Thyroid hormones include thyroxine, triiodothyronine, thyroid-stimulating hormone and the extent of depression, anxiety, and stress
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141025019669N18
Registration date:
2021-04-12, 1400/01/23
Registration timing:
registered_while_recruiting
Last update:
2021-10-23, 1400/08/01
Update count:
1
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Registration date
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2021-04-12, 1400/01/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-09, 1400/01/20
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Expected recruitment end date
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2021-05-10, 1400/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effect of aqueous extract of Illicium verum and placebo on serum levels of thyroid hormones in patients with hypothyroidism: a double-blind randomized clinical trial (Pilot study)
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Public title
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Illicium verum supplementation in patients with hypothyroidism
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with hypothyroidism
Patient 50-20 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
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-03, 1399/12/13
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Ethics committee reference number
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IR.QUMS.REC.1399.521
Health conditions studied
1
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Description of health condition studied
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Hypothyroidism
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ICD-10 code
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E03
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ICD-10 code description
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Other hypothyroidism
Primary outcomes
1
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Description
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Thyroxine hormone
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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ELISA
2
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Description
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Triiodothyronine hormone
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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ELISA
3
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Description
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Thyroid-stimulating hormone
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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ELISA
4
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Description
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Depression Anxiety and Stress
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Depression Anxiety and Stress Scale (DASS-21)
Secondary outcomes
1
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Description
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Body mass index
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Using the formula
Intervention groups
1
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Description
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Intervention group: Aqueous extract of Illicium verum, Three 500 mg capsules per day for two months
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Category
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Treatment - Drugs
2
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Description
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Control group: Three placebo capsules containing wheat flour daily for two months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data after people are unrecognizable
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When the data will become available and for how long
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After completing the study and publishing the article
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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There is nothing wrong with using the data as long as the source of the data is mentioned.
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From where data/document is obtainable
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By contacting the email address of a person responsible for general inquiries khademnut@yahoo.com
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What processes are involved for a request to access data/document
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After consulting with the research team, the data will be provided to the applicant, which will probably be a one-month process.
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Comments
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