Protocol summary
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Study aim
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The effect of garlic intake on oxidative stress, insulin resistance, lipid profile and testosterone hormone in women with PCOS
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Design
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This study is a double blind randomized clinical trial.
The block randomization method is used. The randomization unit is individual. The randomization tool is a random number table. The sample size is 68 people.
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Settings and conduct
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We select 68 women with PCOS referring to a gynecologist's office using available sampling.Then we randomly divide them into 2 groups of garlic and placebo tablets.Then their fasting blood samples are taken and we will give 800 mg of garlic or placebo tablet to each intervention group for daily intervention. After 8 weeks fasting blood samples will be taken to determine relevant markers.In this study, all participants, executor of plan, researcher, health care personnel such as physician and all laboratory personnel are kept blind to assigned study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:minimum age 18 and maximum 45 years
Not following a specific diet or exercise program
Not taking any of: Alcohol, tobacco, anti-estrogens, oral or injectable corticosteroids, anticoagulants like warfarin and heparin and not taking aspirin
No history of any allergy or intolerance to garlic and its products
Do not take garlic pills or supplements containing garlic at least 2 months before intervention
Not being pregnant, Lactation or menopause
No other endocrine disorders
Not using any drug or surgical treatment to treat clinical symptoms and disorders (PCOS) except OCP and metformin
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Intervention groups
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We will give 800 mg of garlic or placebo daily to each intervention group to start the intervention.
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Main outcome variables
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Effect of Garlic Tablets on Insulin Resistance of Glucose Levels, Antioxidant Capacity (TAC), Malondialdehyde (MDA), Lipid Profile and Testosterone Hormone in Patients with PCOS
General information
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Reason for update
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The reason for updating is to add new variables and code of ethics related to the new variables to the current research.
Due to adding new variables to the current study, this research has two codes of ethics.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161203031212N2
Registration date:
2020-02-26, 1398/12/07
Registration timing:
registered_while_recruiting
Last update:
2021-03-13, 1399/12/23
Update count:
1
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Registration date
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2020-02-26, 1398/12/07
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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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2020-02-20, 1398/12/01
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Expected recruitment end date
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2020-04-20, 1399/02/01
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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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The effect of Garlic (Allium sativum) consumption on indices of oxidative stress, insulin resistance, lipid profile and testosterone hormone in women with polycystic ovary syndrome(PCOS)
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Public title
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The effect of garlic on polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
All women with polycystic ovary syndrome who are at least 18 and up to 45 years old
Exclusion criteria:
People who follow a certain diet
People who follow a specific exercise program
People undergoing any drug treatment such as spironolactone, finasteride, isotretinoin, letrozole, clomiphene, gonadotropins, rosiglitazone, pioglitazone, or surgery such as laparoscopic ovarian surgery and assisted reproductive technology (PCOS) to treat symptoms they do
Any serious or significant systemic illness requiring treatment such as cancer, gastrointestinal, hepatic or endocrine disorders, thyroid dysfunction, diabetes mellitus, hyperprolactinemia, cardiovascular disorders, renal disorders, blood coagulation disorders, neurological disorders, Insomnia, Pemphigus Disease, Joint Rheumatism and Non-Related Reproductive Disorders (PCOS)
History of pregnancy hypertension
Family history of stroke
Any of the following: Alcohol, tobacco, anti-estrogens, oral or injectable corticosteroids
Pregnancy
lactation
Menopause
Use of anticoagulants such as warfarin and heparin, Taking aspirin
History of any allergy, intolerance or harmful drug reaction to garlic and its products
Taking garlic pills or supplements containing garlic at least 2 months before the intervention
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Age
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From 18 years old to 45 years old
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Gender
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Female
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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
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization is used. The randomization unit is individual. The randomization tool is a random number table.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is a double-blind clinical trial. In this study, all participants, executor of plan, researcher, health care personnel such as physician and all laboratory personnel are kept blind to assigned study groups.
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Placebo
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Used
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Assignment
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Factorial
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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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2019-06-26, 1398/04/05
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1398.187
2
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Ethics committee
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Approval date
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2021-03-10, 1399/12/20
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1399.806
Health conditions studied
1
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Description of health condition studied
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Polycystic Ovarian Syndrome(PCOS)
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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(PCOS)
Primary outcomes
1
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Description
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Total Antioxidant Capacity (TAC)
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Colorimetric method
2
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Description
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Malon Di Aldehyde (MDA)
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Colorimetric method
3
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Description
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Lipid profile
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Spectrophotometry
4
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Description
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Fasting blood sugar(FBS)
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Spectrophotometry
5
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Description
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Insulin
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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It will be measured by ELISA kit
6
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Description
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Insulin Resistance (HOMA-IR)
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Will be measured computationally
7
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Description
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Testosterone hormone
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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It will be measured by ELISA kit
8
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Description
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glutathione(GSH)
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Colorimetric method
9
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Description
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Catalase(CAT)
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Colorimetric method
10
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Description
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Sex Hormone Binding Globulin (SHBG)
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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It will be measured by ELISA kit
Secondary outcomes
1
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Description
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blood pressure
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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sphygmomanometer
2
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Description
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Weight
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Balance
3
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Description
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Body Mass Index(BMI)
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Balance and meter
4
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Description
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Waist
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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meter
5
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Description
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Around the abdomen
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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meter
6
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Description
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Hip circumference
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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meter
Intervention groups
1
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Description
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Intervention group: The intervention group consumed 800 mg of garlic tablets daily for 2 months.
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Category
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Treatment - Other
2
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Description
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The control group consumed 800 mg of placebo daily for 2 months.
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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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Yes
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Title of funding source
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Esfahan 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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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not 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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No - There is not a plan to make this available
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Title and more details about the data/document
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If the individual data of the sample is unrecognizable, sharing the whole data is fine.
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When the data will become available and for how long
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3 months after the results
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To whom data/document is available
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This data is only available to academic researchers.
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Under which criteria data/document could be used
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The data is for personal use only and is not licensed for analysis.
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From where data/document is obtainable
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Amir Mansour Alavi Naini
Email address: am.alavi@nutr.mui.ac.ir
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What processes are involved for a request to access data/document
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The applicant can send his application to the responsible author's email address and after reviewing the application, documentation is provided to the applicant.
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Comments
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