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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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History
# Registration date Revision Id
4 2024-10-28, 1403/08/07 330588
3 2024-06-12, 1403/03/23 305012
2 2024-05-27, 1403/03/07 304336
1 2023-03-28, 1402/01/08 259987
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  • Protocol summary

    بررسی تاثیر گیاه پنج انگشت بر سطح سرمی برخی متغییر های بیوشیمیایی در زنان مبتلا به سندرم تخمدان پلی کیستیک
    بررسی تاثیر گیاه پنج انگشت بر سطح سرمی برخی متغیر های بیوشیمیایی در زنان مبتلا به سندرم تخمدان پلی کیستیک
    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.
    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.
    این مطالعه کار آزمایی بالینی دو سو کور شامل 60 نفر مبتلا به سندروم تخمدان پلی کیستیک است که به شکل تصادفی ساده به دو گروه دریافت کننده گیاه پنج انگشت و دریافت کننده دارونما تقسیم می شوند. این دو گروه از نظر سن و BMI با یکدیگر همسان سازی خواهند شد.
    این مطالعه کار آزمایی بالینی دو سوکور که دارای دو گروه کنترل و مداخله است، شامل 60 خانم مبتلا به سندرم تخمدان پلی کیستیک می باشد که با استفاده از روش تخصیص تصادفی با بلوک های چهارتایی 30 نفر در گروه کنترل و 30 نفر در گروه دارو قرار می گیرند.
    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.
    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.
    هدف از مطالعه و نحوه انجام آن به بیماران توضیح داده خواهد شد و رضایتنامه کتبی جهت شرکت در مطالعه از آنها اخذ خواهد شد. در ابتدای مطالعه از بیماران نمونه خون گرفته می شود (نمونه گیری در کلینیک صورت می گیرد) و فاکتورهای نظیر قندخون، چربی خون و غیره اندازه گیری می شوند( اندازی گیری فاکتورها در آزمایشگاه دانشگاه صورت می گیرد). سپس داروی گیاهی در افراد شرکت کننده در مطالعه به مدت 12هفته مورد استفاده قرار گرفته و پس از این مدت نیز مجددا خونگیری و اندازه گیری فاکتورها به منظور ارزیابی میزان تاثیر دارو انجام خواهد شد. بیماران از نوع داروی مصرفی و متخصص آمار از گروه بندی انجام شده اطلاع نخواهند داشت.
    هدف از مطالعه و نحوه انجام آن به بیماران توضیح داده خواهد شد و رضایت نامه کتبی جهت شرکت در مطالعه، در بیمارستان طالقانی اراک از آنها اخذ خواهد شد. در ابتدای مطالعه از بیماران نمونه خون گرفته می شود (نمونه گیری در کلینیک صورت می گیرد) و فاکتورهایی نظیر چربی خون و غیره اندازه گیری می شوند (اندازه گیری فاکتورها در آزمایشگاه دانشگاه علوم پزشکی اراک صورت می گیرد). سپس داروی گیاهی در افراد شرکت کننده در مطالعه به مدت 12هفته مورد استفاده قرار گرفته و پس از این مدت نیز مجددا خونگیری و اندازه گیری فاکتورها به منظور ارزیابی میزان تاثیر دارو انجام خواهد شد. بیماران از نوع داروی مصرفی و متخصص آمار از گروه بندی انجام شده اطلاع نخواهند داشت.
    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.
    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.
    یک گروه قرص آگنوگل (یک عدد قرص روکش دار محتوی عصاره ی خشک میوه ی گیاه پنج انگشت با دوز 5.35 میلی گرم در روز) و گروه دوم کپسول حاوی نشاسته با همان دوز
    یک گروه قرص آگنوگل (یک عدد قرص روکش دار محتوی عصاره ی خشک میوه ی گیاه پنج انگشت با دوز 5.35 میلی گرم در روز) و گروه دوم قرص دارونما مشابه قرص آگنوگل
    marker of oxidative stress; lipid profile and insulin resistance
    Markers of oxidative stress and inflammation
    نشانگر های استرس اکسیداتیو؛ پروفایل لیپیدی و مقاومت به انسولین
    شناساگرهای استرس اکسیداتیو و التهاب

  • General information

    empty
    60
    empty
    2023-04-04, 1402/01/15
    empty
    2024-01-20, 1402/10/30
    empty
    Due to the impossibility of counting the number of ovarian follicles as the primary outcome variable, and the need for the appearance of the drug and the placebo to be similar, and with the approval of the research council of the relevant center, this outcome was removed from the list of study outcomes and the form of the placebo was changed from a capsule to a tablet similar to the drug.
    empty
    با توجه به عدم امکان شمارش تعداد فولیکول های تخمدان به عنوان متغیر پیامد اولیه، و لزوم تشابه ظاهری دارو و دارونما و با تایید شورای پژوهشی مرکز مربوطه این پیامد از لیست پیامد های مطالعه حذف و شکل دارو نما از کپسول به قرص مشابه دارو تغییر یافت.
    بررسی اثر گیاه پنج انگشت بر برخی نشانگر های استرس اکسیداتیو، پروفایل لیپیدی و مقاومت به انسولین در زنان مبتلا به سندرم تخمدان پلی کیستیک: یک مطالعه ی کار آزمایی بالینی تصادفی دو سو کور
    اثر گیاه پنج انگشت بر برخی نشانگر های استرس اکسیداتیو، پروفایل لیپیدی و مقاومت به انسولین در زنان مبتلا به سندرم تخمدان پلی کیستیک: یک مطالعه ی کار آزمایی بالینی تصادفی دو سو کور
    از روش تخصیص تصادفی استفاده می شود و بيماران با روش تخصیص تصادفی بلوكي با بلوك هاي چهار تايي در گروه مداخله یا كنترل قرار مي‌گيرند. با اختصاص حرف A به گروه مداخله وحرف B به گروه كنترل، شش حالت AABB،BBAA ،BABA ،ABBA ،BAAB و ABAB در برگه هاي جداگانه نوشته شده و در ظرفي ریخته مي‌شود و هربار يكي از برگه ها از ظرف خارج می شود و تركيب نوشته شده در روي آن يادداشت مي شود و مجددا آن برگه به داخل ظرف انداخته مي‌شود. از آنجایی که حجم نمونه در اين مطالعه 60 نفر است اين عمل 15 بار تكرار مي‌شود و هر بار تركيب نوشته شده بر روي هر برگه در دنباله ترتيب نوشته شده برگه قبلي يادداشت مي شود. سپس به هر يك از حروف يك عدد از يک تا شصت به ترتيب حروف يادداشت شده پشت سر هم اختصاص داده مي‌شود و هر يک از حروف داخل يك پاكت گذاشته شده و روي پاكت عدد آن حرف نوشته مي‌شود. هر بار كه بيماري انتخاب مي‎ شود يكي از پاكت ها به ترتيب عدد نوشته شده روي پاكت باز شده و مشخص مي‌شود كه بيمار بايد در گروه مداخله و يا كنترل قرار بگيرد.
    از روش تخصیص تصادفی استفاده می شود و بيماران با روش تخصیص تصادفی بلوكي با بلوك هاي چهار تايی در گروه مداخله یا كنترل قرار می گيرند. با اختصاص حرف A به گروه مداخله وحرف B به گروه كنترل، شش حالت AABB،BBAA ،BABA ،ABBA ،BAAB و ABAB در برگه های جداگانه نوشته شده و در ظرفی ریخته مي‌شود و هربار يكی از برگه ها از ظرف خارج می شود و تركيب نوشته شده در روی آن يادداشت می شود و مجددا آن برگه به داخل ظرف انداخته می شود. از آنجایی که حجم نمونه در اين مطالعه 60 نفر است اين عمل 15 بار تكرار می شود و هر بار تركيب نوشته شده بر روی هر برگه در دنباله ترتيب نوشته شده برگه قبلی يادداشت مي شود. سپس به هر يك از حروف يك عدد از يک تا شصت به ترتيب حروف يادداشت شده پشت سر هم اختصاص داده می شود و هر يک از حروف داخل يك پاكت گذاشته شده و روی پاكت عدد آن حرف نوشته می شود. هر بار كه بيماری انتخاب می‎ شود يكي از پاكت ها به ترتيب عدد نوشته شده روی پاكت باز شده و مشخص می شود كه بيمار بايد در گروه مداخله و يا كنترل قرار بگيرد.

  • Primary outcomes

    #1
    HOMA-B
    Insulin resistance
    #2
    The number of ovarian follicles
    Number of periods
    تعداد فولیکول های تخمدان
    تعداد قاعدگی
    Ultrasonography
    To ask the patient
    سونوگرافی
    پرسش از بیمار
    #3
    Ovary volume
    The rate of hirsutism
    حجم تخمدان
    میزان هیرسوتیسم
    Ultrasonography
    Ferriman_gallway score
    سونوگرافی
    مقیاس نمره دهی فریمن- گالوی
    #4
    Number of periods
    Insulin
    تعداد قاعدگی
    انسولین
    Before and 12 weeks after the intervention
    Before and after 12 weeks of intervention
    To ask the patient
    ELISA
    پرسش از بیمار
    الایزا
    #5
    The rate of hirsutism
    Cholesterol
    میزان هیرسوتیسم
    کلسترول
    Ferriman_gallway score
    Colorimetric
    مقیاس نمره دهی فریمن- گالوی
    کالریمتری
    #6
    Insulin
    Ovary volume
    انسولین
    حجم تخمدان
    Before and after 12 weeks of intervention
    Before and 12 weeks after the intervention
    ELISA
    Ultrasonography
    الایزا
    سونوگرافی
    #7
    Cholesterol
    empty
    کلسترول
    empty
    Before and 12 weeks after the intervention
    empty
    قبل از مداخله و 12 هفته بعد از مداخله
    empty
    Colorimetric
    empty
    کالریمتری
    empty

  • Secondary outcomes

    #1
    Weight/Height
    Weight /( height)^2
    نسبت وزن به قد
    وزن/(قد)^2

  • Intervention groups

    #1
    Control group: one capsule placebo starch (460 mg) per day for 12 weeks
    Control group: placebo tablet similar to Agnugol,1 pill per day for 12 weeks
    گروه کنترل: یک کپسول نشاسته (460 میلی گرم) یک عدد در روز برای مدت 12 هفته
    گروه کنترل: قرص دارونما مشابه قرص آگنوگل 1 عدد در روز برای مدت 12 هفته

Protocol summary

Study aim
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
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.
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
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 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.
Main outcome variables
Markers of oxidative stress and inflammation

General information

Reason for update
Due to the impossibility of counting the number of ovarian follicles as the primary outcome variable, and the need for the appearance of the drug and the placebo to be similar, and with the approval of the research council of the relevant center, this outcome was removed from the list of study outcomes and the form of the placebo was changed from a capsule to a tablet similar to the drug.
Acronym
IRCT registration information
IRCT registration number: IRCT20230222057493N1
Registration date: 2023-03-28, 1402/01/08
Registration timing: prospective

Last update: 2024-06-08, 1403/03/19
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
2023-04-04, 1402/01/15
Actual recruitment end date
2024-01-20, 1402/10/30
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
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.1401.333

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
Insulin resistance
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
Number of periods
Timepoint
Before and 12 weeks after the intervention
Method of measurement
To ask the patient

17

Description
The rate of hirsutism
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Ferriman_gallway score

18

Description
Insulin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA

19

Description
Cholesterol
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Colorimetric

20

Description
Ovary volume
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Ultrasonography

Secondary outcomes

1

Description
Body mass index (BMI)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Weight /( height)^2

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: placebo tablet similar to Agnugol,1 pill 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
Comments
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