Investigation the effects of Arctium Lappa root powder on some markers of oxidative stress and inflammation in women with polycystic ovary syndrome: a randomized double blind clinical trial study
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General information
Due to the impossibility of accurately counting the number of ovarian follicles as a primary outcome variable, and with the approval of the research council of the relevant center, this outcome was removed from the list of relevant outcomes.
Adding a new ethics committee reference number for the research plan defined on this clinical trial and adding the factors to be measured in this plan(TNF-α, IL6 and AMH).
Due to the impossibility of accurately counting theAdding a new ethics committee reference number of ovarian follicles as a primary outcome variable, and with the approval offor the research council ofplan defined on this clinical trial and adding the relevant center,factors to be measured in this outcome was removed from the list of relevant outcomesplan(TNF-α, IL6 and AMH).
با توجه به عدم امکان شمارش دقیق تعداد فولیکول های تخمدان به عنوان متغیر پیامد اولیه، و با تایید شورای پژوهشی مرکز مربوطه، این پیامد از لیست پیامد های مربوطه حذف شد.
افزودن کد کمیته اخلاق جدید جهت طرح تحقیقاتی تعریف شده بر روی این کارآزمایی بالینی و افزودن فاکتور های مورد سنجش در این طرح(IL6، TNF-α و AMH).
با توجه به عدم امکان شمارش دقیق تعداد فولیکولافزودن کد کمیته اخلاق جدید جهت طرح تحقیقاتی تعریف شده بر روی این کارآزمایی بالینی و افزودن فاکتور های تخمدان به عنوان متغیر پیامد اولیهمورد سنجش در این طرح(IL6، TNF-α و با تایید شورای پژوهشی مرکز مربوطه، این پیامد از لیست پیامد های مربوطه حذف شدAMH).
Ethics committees
#1
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2024-05-19, 1403/02/30
2024-05-19 00:00:00
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IR.ARAKMU.REC.1403.060
IR.ARAKMU.REC.1403.060
Primary outcomes
#1
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Tumor necrosis factor-alpha
Tumor necrosis factor-alpha
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فاکتور نکروزدهنده تومور-آلفا
فاکتور نکروزدهنده تومور-آلفا
empty
Before and after 12 weeks of intervention(measuring on 40 patients)
Before and after 12 weeks of intervention(measuring on 40 patients)
empty
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
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ELISA
ELISA
empty
الایزا
الایزا
#2
empty
Interleukin-6
Interleukin-6
empty
اینترلوکین-6
اینترلوکین-6
empty
Before and after 12 weeks of intervention(measuring on 40 patients)
Before and after 12 weeks of intervention(measuring on 40 patients)
empty
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
empty
ELISA
ELISA
empty
الایزا
الایزا
#3
empty
Anti-Mullerian Hormone
Anti-Mullerian Hormone
empty
آنتی مولرین هورمون
آنتی مولرین هورمون
empty
Before and after 12 weeks of intervention(measuring on 40 patients)
Before and after 12 weeks of intervention(measuring on 40 patients)
empty
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
empty
ELISA
ELISA
empty
الایزا
الایزا
Recruitment centers
#1
Name of recruitment center - English: Taleghani Hospital
Name of recruitment center - Persian: بیمارستان طالقانی
Full name of responsible person - English: Hanieh Taheri
Full name of responsible person - Persian: حانیه طاهری
Street address - English: Shora Square, Imam Khomeini Street, Arak
Street address - Persian: اراک، میدان شورا، خیابان امام خمینی (ره)
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3848176941
Phone: +98 86 3277 4001
Fax:
Email: haniehtaheri1997@yahoo.com
Web page address:
Name of recruitment center - English: Taleghani Hospital
Name of recruitment center - Persian: بیمارستان طالقانی
Full name of responsible person - English: Hanieh Taheri
Full name of responsible person - Persian: حانیه طاهری
Street address - English: Imam Khomeini Street, Shora Square, Arak
Street address - Persian: اراک، میدان شورا، خیابان امام خمینی (ره)
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3848176941
Phone: +98 86 3277 4001
Fax:
Email: haniehtaheri1997@yahoo.com
Web page address:
Name of recruitment center - English: Taleghani Hospital Name of recruitment center - Persian: بیمارستان طالقانی Full name of responsible person - English: Hanieh Taheri Full name of responsible person - Persian: حانیه طاهری Street address - English: Shora Square, Imam Khomeini Street, Shora Square, Arak Street address - Persian: اراک، میدان شورا، خیابان امام خمینی (ره) City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3848176941 Phone: +98 86 3277 4001 Fax: Email: haniehtaheri1997@yahoo.com Web page address:
Protocol summary
Study aim
Effects of Arctium Lappa root on serum levels of some biochemical variables in women with polycystic ovary syndrome
Design
In this randomized, double-blind, phase 2 study, a total number of 60 people with polycystic ovary syndrome will be selected. They will be divided into two groups of Arctium Lappa root and placebo by block 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 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 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
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 because the profile of therapeutic drugs of people who intend to become pregnant is different from those who do not intend to become pregnant.The exclusion criteria are:consumption anticoagulant drugs and antioxidant and anti-inflammatory supplements 3 months before the study; suffering from diabetes;thyroid disorders;and hyperprolactinemia.
Intervention groups
Recipient group of Arctium Lappa root(One 460 mg capsule per day)and recipient group contains starch with the same dose.
Main outcome variables
Markers of oxidative stress and inflammation
General information
Reason for update
Adding a new ethics committee reference number for the research plan defined on this clinical trial and adding the factors to be measured in this plan(TNF-α, IL6 and AMH).
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057492N1
Registration date:2023-03-29, 1402/01/09
Registration timing:prospective
Last update:2024-06-12, 1403/03/23
Update count:4
Registration date
2023-03-29, 1402/01/09
Registrant information
Name
Hanieh Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3383 8278
Email address
hanieh.taheri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
2023-04-04, 1402/01/15
Actual recruitment end date
2024-01-20, 1402/10/30
Trial completion date
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Scientific title
Investigation the effects of Arctium Lappa root powder on some markers of oxidative stress and inflammation in women with polycystic ovary syndrome: a randomized double blind clinical trial study
Public title
Investigation the effects of Arctium Lappa root powder 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 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
consumption of anticoagulant drugs and antioxidant and anti-inflammatory supplements for 3 months before the study.
Pregnancy
Breastfeeding
Diabetes
Thyroid disorders
Hyperprolactinemia
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
Actual sample size reached:
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.1401.334
2
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
2024-05-19, 1403/02/30
Ethics committee reference number
IR.ARAKMU.REC.1403.060
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
Superoxide dismutase
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
2
Description
Catalase
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
3
Description
Glutathione peroxidase
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
4
Description
Reduced glutathione
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
5
Description
Oxidized glutathione
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
6
Description
The ratio of reduced glutathione to oxidized glutathione
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
7
Description
Total antioxidant capacity
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
8
Description
Total oxidant status
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
9
Description
Oxidative stress index
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
10
Description
Malondialdehyde
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
11
Description
Ratio of malondialdehyde to total antioxidant capacity
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
12
Description
Total antioxidant gap
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
13
Description
Total Thiol
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
14
Description
High-sensitivity C-reactive protein
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Immunoturbidimetry
15
Description
The ratio of high-sensitivity C-reactive protein to albumin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
16
Description
The ratio of blood urea nitrogen to albumin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
17
Description
Albumin bilirubin score
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
18
Description
Triglyceride-Glucose index
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
19
Description
Ovary volume
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Ultrasonography
20
Description
The rate of hirsutism
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Ferriman-Gallwey scoring scale
21
Description
Number of periods
Timepoint
Before and after 12 weeks of intervention
Method of measurement
To ask the patient
22
Description
Tumor necrosis factor-alpha
Timepoint
Before and after 12 weeks of intervention(measuring on 40 patients)
Method of measurement
ELISA
23
Description
Interleukin-6
Timepoint
Before and after 12 weeks of intervention(measuring on 40 patients)
Method of measurement
ELISA
24
Description
Anti-Mullerian Hormone
Timepoint
Before and after 12 weeks of intervention(measuring on 40 patients)
Method of measurement
ELISA
Secondary outcomes
1
Description
Body mass index
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
Intervention groups
1
Description
Intervention group: One capsule Arctium Lappa root powder (460 mg) per day for 12 weeks.
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
Hanieh Taheri
Street address
Imam Khomeini Street, Shora Square, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3277 4001
Email
haniehtaheri1997@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 3638
Email
Research@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
Hanieh Taheri
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
haniehtaheri1997@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hanieh Taheri
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
haniehtaheri1997@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hanieh Taheri
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
haniehtaheri1997@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
Ali Khosrowbeygi a.khosrowbeygi@arakmu.ac.ir
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.