Protocol summary
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Study aim
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Evaluation of Iranian Traditional medicine-based diet on anthropometric and metabolic factors
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Design
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Randomized controlled Clinical trial on 30 women with PCOs
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Settings and conduct
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Patients with PCOS are referred to the women's clinic of Taleghani Hospital which meets the inclusion criteria. After obtaining written consent, they will enter the study, then during 8 weeks, they will be randomly divided into the group receiving lifestyle modification recommendations and diet based on traditional medicine and the group receiving lifestyle modification recommendations. At the beginning and end of the study Anthropometric indicators of patients are measured and blood tests are also performed. Visiting and consulting patients is done separately and on different days
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Participants/Inclusion and exclusion criteria
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Women aged 28 to 42 with polycystic ovary syndrome, with a body mass index of 25 and above, who do not have diabetes, do not take hormonal and insulin regulatory drugs, do not have thyroid hormone disorders, hyperprolactinemia, and adrenal disorders.
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Intervention groups
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15 women with PCOs receive diet and recommendations for lifestyle modification
15 women with PCOs receive recommendations for lifestyle modification
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Main outcome variables
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FBS, insulin, HOMA, VAI, lipid profile, BMI, WHR
General information
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Reason for update
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Given the slow sampling process, calculations and revisions were performed by statisticians, and the sample size was adjusted based on previous similar studies. All steps were supervised by professors and approved by the faculty's educational council.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230627058594N1
Registration date:
2023-09-01, 1402/06/10
Registration timing:
prospective
Last update:
2026-06-03, 1405/03/13
Update count:
1
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Registration date
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2023-09-01, 1402/06/10
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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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2023-09-23, 1402/07/01
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Expected recruitment end date
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2024-09-22, 1403/07/01
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Actual recruitment start date
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2024-09-22, 1403/07/01
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Actual recruitment end date
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2026-01-02, 1404/10/12
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Trial completion date
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2026-01-02, 1404/10/12
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Scientific title
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Metabolic Effects of Iranian Medicine-Based Diet in Women with Polycystic Ovarian Syndrome
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Public title
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Effect of Diet in Polycystic Ovarian Syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with polycystic ovarian syndrome
Body mass index>= 25
Exclusion criteria:
Diabetic patients
Taking insulin-regulatory drugs
Taking hormonal and supplemental drugs
Thyroid hormone disorder
Prolactin level disorder
Adrenal disorder
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Age
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From 18 years old to 42 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
Actual sample size reached:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The population of eligible women is randomly assigned to two groups of at least 15 each, A and B, using a random number table.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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This study offers traditional-available foods for lifestyle modification and improvement of women with polycystic ovarian syndrome
Ethics committees
1
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Ethics committee
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Approval date
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2023-05-30, 1402/03/09
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1402.115
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Body mass index
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Calculation
2
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Description
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Waist circumference
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Tape measuring
3
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Description
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Hip circumference
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Tape measuring
4
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Description
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FBS
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Enzymatic method
5
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Description
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Triglyceride
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Enzymatic method
6
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Description
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Serum HDL
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Enzymatic method
7
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Description
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Insulin
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Eliza
8
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Description
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FBS/fasting Insulin
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Calculation
9
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Description
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Visceral adiposity index
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Timepoint
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Before intervention and 2 months later
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Method of measurement
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Calculation
Intervention groups
1
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Description
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Intervention group: for 8 weeks, an Iranian traditional medicine-based diet is provided along with recommendations for lifestyle modification, and to follow the program, a telephone connection is made every 2 weeks.
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Category
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Lifestyle
2
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Description
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Control group: They receive lifestyle modification recommendations for 8 weeks
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Category
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Lifestyle
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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Shahid Beheshti 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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available