Protocol summary
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Study aim
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Evaluation of effect of hydroalcoholic extract of trifolium plant in patients with subclinical hypothyroidism
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Design
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This clinical trial was performed on 40 patients, divided into two groups of 20, including a control group and parallel groups. This study is blinded and simple randomization is used.
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Settings and conduct
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The field of work is clinical - internal. This study is performed in the Tohid Hospital in Sanandaj. The intervention group is given a 500 mg capsule of hydroalcoholic extract of trifolium plant daily for three months, along with standard treatment. The control group is also given a daily placebo for three months, along with standard treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with lately diagnosed subclinical hypothyroidism
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Intervention groups
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Intervention group: hydroalcoholic extract of trifolium plant, oral capsule, 500 mg, Once a day for three months with standard treatment
Control group: placebo containing starch, oral capsule, 500 mg, Once a day for three months with standard treatment
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Main outcome variables
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Serum TSH levels; Serum T4 levels; Serum T3 levels
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:
IRCT20190415043279N3
Registration date:
2020-05-24, 1399/03/04
Registration timing:
registered_while_recruiting
Last update:
2025-11-05, 1404/08/14
Update count:
1
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Registration date
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2020-05-24, 1399/03/04
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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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2020-01-21, 1398/11/01
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Expected recruitment end date
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2020-06-21, 1399/04/01
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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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Evaluation of effect of hydroalcoholic extract of trifolium plant in patients with subclinical hypothyroidism
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Public title
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Evaluation of effect of trifolium plant on 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 lately diagnosed subclinical hypothyroidism
Exclusion criteria:
Thyroiditis
Pregnancy
Cardiovascular disease
Thyroid cancer
Recent surgery
Blood disorders
children
Breastfeeding
chronic Diseases
Dissatisfaction patients to participate in the study
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Age
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From 18 years old to 70 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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive (Capsule containing hydroalcoholic extract of trifolium plant) and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.
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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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2019-03-16, 1397/12/25
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Ethics committee reference number
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IR.MUK.REC.1397/384
Health conditions studied
1
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Description of health condition studied
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Subclinical hypothyroidism
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ICD-10 code
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E02
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ICD-10 code description
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Subclinical iodine-deficiency hypothyroidism
Primary outcomes
1
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Description
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Serum TSH levels
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Timepoint
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Measurement of TSH levels before the intervention and three months later
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Method of measurement
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Serum level evaluation
2
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Description
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Serum T4 levels
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Timepoint
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Measurement of T4 levels before the intervention and three months later
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Method of measurement
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Serum level evaluation
3
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Description
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Serum T3 levels
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Timepoint
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Measurement of T3 levels before the intervention and three months later
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Method of measurement
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Serum level evaluation
Intervention groups
1
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Description
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Intervention group: Capsule containing hydroalcoholic extract of trifolium plant at a dose of 500 mg per day for three consecutive months. These oral capsules of trifolium plant are prepared by a reputable pharmacist.
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Category
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Placebo
2
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Description
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Control group: Placebo in capsules at a dose of 500 mg per day for three consecutive months These placebo oral capsules contain starch and are prepared by a reputable pharmacist.
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Category
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Placebo
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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No
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Title of funding source
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Sanandaj 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable