Protocol summary
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Study aim
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The effect of Vitex agnus_castus plant on some marker of oxidative stress, lipid profile and insulin resistance in women with polycystic ovary syndrome: A randomized double blind clinical trial study
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Design
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This double-blind clinical trial study, which has two control and intervention groups, includes 60 women with polycystic ovary syndrome that using a random allocation method with blocks of four, 30 people will allocate in the control group and 30 people in the drug group.
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Settings and conduct
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The purpose of the study and how to do it will be explained to patients and written consent will be obtained from them to participate in the study in Taleghani hospital, Arak. Blood samples are taken from patients at the beginning of the study(Sampling is done in the clinic)and factors such as blood fat and etc. are measured in the blood(measurement is done in the Arak university of medical sciences laboratory).Then, the herbal medicine will be used in the participants for 12 weeks, and after this period, blood samples will be taken again and the factors will be measured again in order to evaluate the effect of the medicine. Patients and specialist will not be aware of the type of groups
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Participants/Inclusion and exclusion criteria
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women in the age range of 18-45 years; whose PCOS has been confirmed by a specialist based on Rotterdam criteria; Only patients who do not intend to become pregnant are allowed to enter our study. The exclusion criteria are thyroid disorders; hyperprolactinemia; diabetes; use of dopamine antagonists and antioxidant supplements.
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Intervention groups
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A group of Agnugel tablets(a coated tablet containing the dry extract of the Vitex agnus_castus plant with a dose of 5.35 mg per day)and the second group of placebo tablet, similar to Agnugol.
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Main outcome variables
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Markers of oxidative stress and inflammation
General information
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Reason for update
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Adding a new ethics committee reference number for the research plan defined on this clinical trial and adding the factors measured in this plan (TNF-α, IL-6 and AMH). Additional clarification and rectification of these items: Inclusion criteria (adding Rotterdam criteria), blinding method description, timepoint of measurement, and also measurement method of the variable "menstrual frequency".
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230222057493N1
Registration date:
2023-03-28, 1402/01/08
Registration timing:
prospective
Last update:
2025-02-15, 1403/11/27
Update count:
3
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Registration date
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2023-03-28, 1402/01/08
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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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2023-04-03, 1402/01/14
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Expected recruitment end date
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2024-04-02, 1403/01/14
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Actual recruitment start date
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2023-04-04, 1402/01/15
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Actual recruitment end date
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2024-01-20, 1402/10/30
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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 Vitex agnus_castus plant on some marker of oxidative stress, lipid profile and insulin resistance in women with polycystic ovary syndrome: A randomized double blind clinical trial study
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Public title
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The effect of Vitex agnus_castus plant in women with 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:
Women in the age range of 18-45 years
Confirmation of PCOS by a specialist doctor, based on Rotterdam criteria
Patient satisfaction to enter the study
Patients who do not intend to become pregnant because the profile of therapeutic drugs for people who intend to become pregnant is different from those who do not intend to become pregnant
Exclusion criteria:
Smoking
Thyroid disorders
Hyperprolactinemia
Diabetes
Pregnancy
Consumption of dopamine antagonists
Consumption of antioxidant supplements
Breastfeeding
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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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2-3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The random allocation method will be used and the patients are placed in the intervention or control group using the block random allocation method with blocks of four. By assigning the letter A to the intervention group and the letter B to the control group, six states AABB, BBAA, BABA, ABBA, BAAB, and ABAB are written on separate sheets and are thrown into a container, and each time one of the sheets is taken out and it's written composition is noted and the sheet is thrown into the container again. Since the sample size in this study is 60, this procedure is repeated 15 times and each time the combination written on each sheet is noted in the sequence of the previous sheet. Then, a number from one to sixty is assigned to each of the letters in the order of the letters noted one after the other, and each of the letters are placed in an envelope and the specific number of each letter is written on the envelope. Every time which a subject is selected, one of the envelopes is opened. According to the number written on the envelope, the patient is introduced into the intervention or control group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants and healthcare providers are blinded. The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive.
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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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2023-02-12, 1401/11/23
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Ethics committee reference number
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IR.ARAKMU.REC.1401.333
2
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Ethics committee
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Approval date
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2024-05-19, 1403/02/30
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Ethics committee reference number
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IR.ARAKMU.REC.1403.061
3
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Ethics committee
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Approval date
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2024-10-06, 1403/07/15
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Ethics committee reference number
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IR.ARAKMU.REC.1403.225
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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Total antioxidant capacity
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
2
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Description
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Total oxidant status
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
3
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Description
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Oxidative stress index
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Formula
4
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Description
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Malondialdehyde
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
5
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Description
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High density lipoprotein (HDL-C)
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Low-density lipoprotein(LDL-C)
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
7
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Description
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Triglyceride
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
8
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Description
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Fasting glucose
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
9
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Description
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Catalase
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
10
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Description
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Insulin resistance
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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HOMA-IR model evaluation
11
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Description
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Reduced Glutathione
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
12
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Description
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Glutathione peroxidase
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
13
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Description
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Total Thiol
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
14
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Description
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Aspartate aminotransferase(AST)
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
15
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Description
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Alanine aminotransferase(ALT)
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
16
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Description
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Number of periods
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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To ask the patient and dividing the total number of menstruations that occurred in three months by the expected number of menstruations (three times in three months).
17
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Description
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The rate of hirsutism
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Ferriman_gallway score
18
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Description
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Insulin
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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ELISA
19
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Description
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Cholesterol
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Colorimetric
20
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Description
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Ovary volume
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Ultrasonography
21
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Description
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Tumor necrosis factor alpha (measuring on 40 patients)
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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ELISA
22
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Description
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Interleukin-6 (measuring on 40 patients)
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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ELISA
23
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Description
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Anti-Mullein Hormone (measuring on 40 patients)
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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ELISA
24
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Description
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C-reactive protein
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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ELISA
25
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Description
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The ratio of C-reactive protein to albumin
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Formula (C-reactive protein / albumin)
26
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Description
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The ratio of blood urea nitrogen to albumin
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Formula (blood urea nitrogen / albumin)
27
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Description
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Albumin bilirubin score
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Formula (Albumin × -0.085) + (log10 Bilirubin × 0.66)
28
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Description
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Triglyceride-Glucose index
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Timepoint
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Before and 12 weeks after the start of the intervention
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Method of measurement
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Formula (Fasting triacylglycerols × Fasting glucose/2)
Secondary outcomes
1
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Description
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Body mass index (BMI)
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Timepoint
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Before and after 12 weeks of intervention
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Method of measurement
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Weight /( height)^2
Intervention groups
1
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Description
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Intervention group: Agnugol tablet (a coated tablet containing the dry extract of the Vitex agnus_castus plant in the amount of 2.3-8.4 mg and an average of 5.35 mg, standardized to 0.42-0.82 mg Aucubin) once a day for 12 weeks(Gol Daro Pharmaceutical Company-Iran-Isfahan Province).
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Category
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Treatment - Drugs
2
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Description
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Control group: placebo tablet similar to Agnugol,1 pill per day for 12 weeks
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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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Arak 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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Yes - There is 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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Only results of main outcomes
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When the data will become available and for how long
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Six months after publishing of the results
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To whom data/document is available
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Only for academic staffs and universities researches
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Under which criteria data/document could be used
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Only for international and between universities researches
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From where data/document is obtainable
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Farideh Jalali-Mashayekhi
mashayekhif@yahoo.com
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What processes are involved for a request to access data/document
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1. Requesting a team work clinical trial via email. 2. Approving the proposal. 3. Registration of the trial
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Comments
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No comments