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
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
Design
In this double blind study, a total number of 60 people with polycystic ovary syndrome will be selected.They will be divided into two groups of Vitex agnus_castus and placebo by simple randomization method. They will be matched in age and BMI.
Settings and conduct
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. Blood samples are taken from patients at the beginning of the study(Sampling is done in the clinic) and factors such as blood sugar, blood fat, etc. are measured in the blood (measurement is done in the university 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 will not be aware of the type of drug and the statistician will not be aware of the type of groups.
Participants/Inclusion and exclusion criteria
The Inclusion criteria for the study are: women in the age range of 18-45 years, whose PCOS has been confirmed by a specialist doctor. 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.
Intervention groups
A group of Agnogel 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 capsules containing starch with the same dose.
Main outcome variables
marker of oxidative stress; lipid profile and insulin resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057493N1
Registration date:2023-03-28, 1402/01/08
Registration timing:prospective
Last update:2023-03-28, 1402/01/08
Update count:3
Registration date
2023-03-28, 1402/01/08
Registrant information
Name
Aniseh Hatami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4230 7793
Email address
a.hatami@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2024-04-02, 1403/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Vitex agnus_castus plant in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women in the age range of 18-45 years
Confirmation of PCOS diagnosis by a specialist doctor
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
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, healthcare providers, and outcome assessors 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. The statistician will not be informed about the grouping done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2023-02-12, 1401/11/23
Ethics committee reference number
IR.ARAKMU.REC.1401.333
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
2
Description
Total oxidant status
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
3
Description
Oxidative stress index
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
4
Description
Malondialdehyde
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
5
Description
High density lipoprotein (HDL-C)
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Spectrophotometry
6
Description
Low-density lipoprotein(LDL-C)
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric
7
Description
Triglyceride
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric
8
Description
Fasting glucose
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
9
Description
Catalase
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
10
Description
HOMA-B
Timepoint
Before and after 12 weeks of intervention
Method of measurement
HOMA-IR model evaluation
11
Description
Reduced Glutathione
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric
12
Description
Glutathione peroxidase
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric
13
Description
Total Thiol
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric
14
Description
Aspartate aminotransferase(AST)
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric
15
Description
Alanine aminotransferase(ALT)
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric
16
Description
The number of ovarian follicles
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Ultrasonography
17
Description
Ovary volume
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Ultrasonography
18
Description
Number of periods
Timepoint
Before and 12 weeks after the intervention
Method of measurement
To ask the patient
19
Description
The rate of hirsutism
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Ferriman_gallway score
20
Description
Insulin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA
21
Description
Cholesterol
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric
Secondary outcomes
1
Description
Body mass index (BMI)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Weight/Height
Intervention groups
1
Description
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) once a day for 12 weeks(Gol Daro Pharmaceutical Company-Iran-Isfahan Province).
Category
Treatment - Drugs
2
Description
Control group: one capsule placebo starch (460 mg) per day for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Aniseh Hatami
Street address
Shora Square, Imam Khomeini Street, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3277 4001
Email
Aniseh.Hatami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Fax
Email
pajoohesh@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aniseh Hatami
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Aniseh.hatami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aniseh Hatami
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3501
Email
Aniseh.hatami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aniseh Hatami
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3501
Email
Aniseh.hatami@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only results of main outcomes
When the data will become available and for how long
Six months after publishing of the results
To whom data/document is available
Only for academic staffs and universities researches
Under which criteria data/document could be used
Only for international and between universities researches
From where data/document is obtainable
Farideh Jalali-Mashayekhi
mashayekhif@yahoo.com
What processes are involved for a request to access data/document
1. Requesting a team work clinical trial via email. 2. Approving the proposal. 3. Registration of the trial