1. Home
  2. Approved trials
  3. » فارسی

Metabolic Effects of Iranian Medicine-Based Diet in Women with Polycystic Ovarian Syndrome

View the latest revision

History
# Registration date Revision Id
2 2026-06-02, 1405/03/12 380469
1 2023-09-01, 1402/06/10 277369
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Randomized controlled Clinical trial on 74 women with PCOs
    Randomized controlled Clinical trial on 30 women with PCOs
    کارازمایی بالینی تصادفی شده بروش تقسیم تصادفی دارای گروه کنترل بر روی 74 زن مبتلا به PCOs
    کارازمایی بالینی تصادفی شده بروش تقسیم تصادفی دارای گروه کنترل بر روی 30 زن مبتلا به PCOs
    37 women with PCOs receive diet and recommendations for lifestyle modification 37 women with PCOs receive recommendations for lifestyle modification
    15 women with PCOs receive diet and recommendations for lifestyle modification 15 women with PCOs receive recommendations for lifestyle modification
    37 زن مبتلا به PCOs دریافت کننده رژیم غذایی همراه با توصیه های اصلاح سبک زندگی( مداخله) 37 زن مبتلا به PCOs دریافت کننده توصیه های اصلاح سبک زندگی( کنترل)
    15 زن مبتلا به PCOs دریافت کننده رژیم غذایی همراه با توصیه های اصلاح سبک زندگی( مداخله) 15 زن مبتلا به PCOs دریافت کننده توصیه های اصلاح سبک زندگی( کنترل)

  • General information

    Single blinded
    Not blinded
    1
    74
    30
    empty
    32
    empty
    2024-09-22, 1403/07/01
    empty
    2026-01-02, 1404/10/12
    empty
    2026-01-02, 1404/10/12
    empty
    Given the slow sampling process, calculations and revisions were performed by statisticians, and the sample size was adjusted based on previous similar studies. All steps were supervised by professors and approved by the faculty's educational council.
    empty
    با توجه به کندی روند نمونه گیری، محاسبات و بازنگری توسط متخصص امار صورت گرفت و حجم نمونه با توجه به مطالعات پیشین مشابه تغییر پیدا کرد. تمام مراحل با نظارت اساتید و تصویب در شورای اموزشی دانشکده صورت گرفت.
    The population of eligible women will be randomly assigned and placed in two groups of 37, A and B, using a random block permutation design.
    The population of eligible women is randomly assigned to two groups of at least 15 each, A and B, using a random number table.
    جمعیت زنان واجد شرائط بصورت تخصیص تصادفی و با استفاده از طرح تصادفی بلوک جایگشتی در دو گروه 37 تایی A , B قرار میگیرند
    جمعیت زنان واجد شرائط بصورت تخصیص تصادفی با استفاده از جدول اعداد تصادفی در دو گروه حداقل 15 تایی A , B قرار میگیرند.
    In this study, after obtaining consent, eligible individuals are randomly placed in one of two intervention or control groups. In the control group, after the necessary explanations, a sheet containing lifestyle modification recommendations in 15 paragraphs is given to the individual. In the intervention group, in addition to the advice sheet for lifestyle modification, a sheet including a diet based on Iranian traditional medicine is also provided
    در این مطالعه فرد واجد شرایط پس از اخذ رضایتنامه، وبصورت تصادفی در یکی از دو گروه مداخله و یا کنترل قرار میگیرند.در گروه کنترل پس از توضیحات لازم برگه ای شامل توصیه های اصلاح سبک زندگی در 15 بند به فرد داده میشود. در گروه مداخله علاوه بر برگه توصیه های اصلاح سبک زندگی، برگه ای شامل رژیم غذایی مبتنی بر طب ایرانی نیز ارائه میشود

  • Recruitment centers

    #1
    Name of recruitment center - English: Talegani hospital
    Name of recruitment center - Persian: بیمارستان طالقانی
    Full name of responsible person - English: Parivash Gholami
    Full name of responsible person - Persian: پریوش غلامی
    Street address - English: Taleghani hospital, Velenjac, Shahid Chamran highway, Tehran
    Street address - Persian: بیمارستان طالقانی، بلوار دانشجو
    City - English: تهران
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985711151
    Phone: +98 21 2243 2558
    Fax: +98 21 2243 2600
    Email: taleghanihospital@sbmu.ac.ir
    Web page address:
    Name of recruitment center - English: Talegani hospital
    Name of recruitment center - Persian: بیمارستان طالقانی
    Full name of responsible person - English: Parivash Gholami
    Full name of responsible person - Persian: پریوش غلامی
    Street address - English: Taleghani hospital, Velenjac, Shahid Chamran highway, Tehran
    Street address - Persian: بیمارستان طالقانی، بلوار دانشجو
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985711151
    Phone: +98 21 2243 2558
    Fax: +98 21 2243 2600
    Email: taleghanihospital@sbmu.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Afshin Zarghi
    Full name of responsible person - Persian: دکتر افشین زرقی
    Street address - English: 7th floor, Bldg No.2 SBUMS, Arabi Ave, Velenjak, Tehran Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
    Street address - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهیدبهشتی، ولنجک، بلوار دانشجو، دانشگاه علوم پزشکی شهیدبهشتی، بزرگراه چمران- خیابان یمن- خیابان شهید اعرابی- جنب بیمارستان طالقانی- دانشگاه علوم پزشکی شهیدبهشتی- ساختمان ستاد 2- ط 5
    City - English: تهران
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 6941119839
    Phone: +98 21 2243 9781
    Fax:
    Email: Mpajouhesh@sbmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Afshin Zarghi
    Full name of responsible person - Persian: دکتر افشین زرقی
    Street address - English: 7th floor, Bldg No.2 SBUMS, Arabi Ave, Velenjak, Tehran Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
    Street address - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهیدبهشتی، ولنجک، بلوار دانشجو، دانشگاه علوم پزشکی شهیدبهشتی، بزرگراه چمران- خیابان یمن- خیابان شهید اعرابی- جنب بیمارستان طالقانی- دانشگاه علوم پزشکی شهیدبهشتی- ساختمان ستاد 2- ط 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 6941119839
    Phone: +98 21 2243 9781
    Fax:
    Email: Mpajouhesh@sbmu.ac.ir
    Web page address:

Protocol summary

Study aim
Evaluation of Iranian Traditional medicine-based diet on anthropometric and metabolic factors
Design
Randomized controlled Clinical trial on 30 women with PCOs
Settings and conduct
Patients with PCOS are referred to the women's clinic of Taleghani Hospital which meets the inclusion criteria. After obtaining written consent, they will enter the study, then during 8 weeks, they will be randomly divided into the group receiving lifestyle modification recommendations and diet based on traditional medicine and the group receiving lifestyle modification recommendations. At the beginning and end of the study Anthropometric indicators of patients are measured and blood tests are also performed. Visiting and consulting patients is done separately and on different days
Participants/Inclusion and exclusion criteria
Women aged 28 to 42 with polycystic ovary syndrome, with a body mass index of 25 and above, who do not have diabetes, do not take hormonal and insulin regulatory drugs, do not have thyroid hormone disorders, hyperprolactinemia, and adrenal disorders.
Intervention groups
15 women with PCOs receive diet and recommendations for lifestyle modification 15 women with PCOs receive recommendations for lifestyle modification
Main outcome variables
FBS, insulin, HOMA, VAI, lipid profile, BMI, WHR

General information

Reason for update
Given the slow sampling process, calculations and revisions were performed by statisticians, and the sample size was adjusted based on previous similar studies. All steps were supervised by professors and approved by the faculty's educational council.
Acronym
IRCT registration information
IRCT registration number: IRCT20230627058594N1
Registration date: 2023-09-01, 1402/06/10
Registration timing: prospective

Last update: 2026-06-03, 1405/03/13
Update count: 1
Registration date
2023-09-01, 1402/06/10
Registrant information
Name
Parivash Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
dr.p.qolami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
2024-09-22, 1403/07/01
Actual recruitment end date
2026-01-02, 1404/10/12
Trial completion date
2026-01-02, 1404/10/12
Scientific title
Metabolic Effects of Iranian Medicine-Based Diet in Women with Polycystic Ovarian Syndrome
Public title
Effect of Diet in Polycystic Ovarian Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovarian syndrome Body mass index>= 25
Exclusion criteria:
Diabetic patients Taking insulin-regulatory drugs Taking hormonal and supplemental drugs Thyroid hormone disorder Prolactin level disorder Adrenal disorder
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
The population of eligible women is randomly assigned to two groups of at least 15 each, A and B, using a random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study offers traditional-available foods for lifestyle modification and improvement of women with polycystic ovarian syndrome

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Univercity of Medical Science
Street address
Shahid Beheshti Univercity of Medical Science, Sh. Arab Ave. Yaman Ave., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.115

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
Body mass index
Timepoint
Before intervention and 2 months later
Method of measurement
Calculation

2

Description
Waist circumference
Timepoint
Before intervention and 2 months later
Method of measurement
Tape measuring

3

Description
Hip circumference
Timepoint
Before intervention and 2 months later
Method of measurement
Tape measuring

4

Description
FBS
Timepoint
Before intervention and 2 months later
Method of measurement
Enzymatic method

5

Description
Triglyceride
Timepoint
Before intervention and 2 months later
Method of measurement
Enzymatic method

6

Description
Serum HDL
Timepoint
Before intervention and 2 months later
Method of measurement
Enzymatic method

7

Description
Insulin
Timepoint
Before intervention and 2 months later
Method of measurement
Eliza

8

Description
FBS/fasting Insulin
Timepoint
Before intervention and 2 months later
Method of measurement
Calculation

9

Description
Visceral adiposity index
Timepoint
Before intervention and 2 months later
Method of measurement
Calculation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: for 8 weeks, an Iranian traditional medicine-based diet is provided along with recommendations for lifestyle modification, and to follow the program, a telephone connection is made every 2 weeks.
Category
Lifestyle

2

Description
Control group: They receive lifestyle modification recommendations for 8 weeks
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Talegani hospital
Full name of responsible person
Parivash Gholami
Street address
Taleghani hospital, Velenjac, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
+98 21 2243 2600
Email
taleghanihospital@sbmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
7th floor, Bldg No.2 SBUMS, Arabi Ave, Velenjak, Tehran Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
City
Tehran
Province
Tehran
Postal code
6941119839
Phone
+98 21 2243 9781
Fax
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parivash Gholami
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
City
تهران
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.p.qolami@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parivash Gholami
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
City
تهران
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.p.qolami@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parivash Gholami
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.p.qolami@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...