History
# Registration date Revision Id
3 2025-08-25, 1404/06/03 352707
2 2025-02-21, 1403/12/03 333457
1 2020-12-22, 1399/10/02 164092
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  • General information

    empty
    Some essential data were omitted due to oversight during the initial registration, so this update has been made to complete them.
    empty
    برخی از داده های ضروری به دلیل فراموشی در زمان ثبت اولیه وارد نشده بودند، و این به روزرسانی برای تکمیل آن ها انجام شده است.
    Determination of the effect of licorice on Sex hormone in participants with polycystic ovary syndrome (PCOS) and overweight / obesity.
    Determination of the effect of licorice on Sex hormone, insulin and fasting blood sugar, blood lipids, depression, sleep quality and appetite in participants with polycystic ovary syndrome (PCOS) and overweight / obesity.
    بررسی تاثیر شیرین بیان بر هورمون های جنسی در زنان مبتلا به PCOS با اضافه وزن یا چاقی
    بررسی تاثیر شیرین بیان بر هورمون های جنسی، انسولین و قند خون ناشتا، چربی های خون، افسردگی، کیفیت خواب و اشتها در زنان مبتلا به PCOS با اضافه وزن یا چاقی
    Determination of the effect of licorice extract on testosterone and Sex hormone binding globulin (SHBG) in participants with polycystic ovary syndrome (PCOS) and overweight / obesity.
    Determination of the effect of licorice extract on testosterone and Sex hormone binding globulin (SHBG), LH, FSH, Insulin, FBS, LDL, HDL, TG, Cholesterol, sleep quality, depression, and appetite in participants with polycystic ovary syndrome (PCOS) and overweight / obesity.
    بررسی تأثیر عصاره شیرین بیان بر تستوسترون و گلوبولین متصل شونده به هورمون های جنسی (SHBG) در مبتلایان به سندروم تخمدان پلی کیستیک (PCOS) با اضافه وزن یا چاقی
    بررسی تأثیر عصاره شیرین بیان بر تستوسترون، گلوبولین متصل شونده به هورمون های جنسی (SHBG)، FSH, LH , انسولین، قند خون ناشتای سرم (FBS)، LDL، HDL، TG و کلسترول، کیفیت خواب، اشتها و افسردگی در مبتلایان به سندروم تخمدان پلی کیستیک (PCOS) با اضافه وزن یا چاقی
  • Primary outcomes

    #1
    سطوح تستوسترون سرم
    سطح تستوسترون سرم
    #2
    Serum SHBG level
    empty
    سطح SHBG سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    ELISA Kit
    empty
    کیت الایزا
    empty
    #3
    Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, abdominal / hip ratio)
    empty
    اندازه های آنتروپومتری (قد، وزن، شاخص توده بدنی، دور کمر، دور باسن، نسبت دور شکم به دور باسن)
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Body analyzer
    empty
    دستگاه بادی آنالیزور
    empty
    #4
    Body composition
    empty
    ترکیب بدن
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Body analyzer
    empty
    دستگاه بادی آنالیزور
    empty
  • Secondary outcomes

    #1
    empty
    Serum SHBG level
    empty
    سطح SHBG سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    ELISA Kit
    empty
    کیت الایزا
    #2
    empty
    Serum FSH level
    empty
    سطح FSH سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    ELISA Kit
    empty
    کیت الایزا
    #3
    empty
    Serum LH level
    empty
    سطح LH سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    ELISA Kit
    empty
    کیت الایزا
    #4
    empty
    Serum insulin level
    empty
    سطح انسولین سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    ELISA Kit
    empty
    کیت الایزا
    #5
    empty
    Serum FBS level
    empty
    سطح قند خون ناشتای سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Biochemical analysis
    empty
    آنالیز بیوشیمیایی
    #6
    empty
    Serum LDL level
    empty
    سطح LDL سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Biochemical analysis
    empty
    آنالیز بیوشیمیایی
    #7
    empty
    Serum HDL level
    empty
    سطح HDL سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Biochemical analysis
    empty
    آنالیز بیوشیمیایی
    #8
    empty
    Serum TG level
    empty
    سطح TG سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Biochemical analysis
    empty
    آنالیز بیوشیمیایی
    #9
    empty
    Serum Cholesterol level
    empty
    سطح کلسترول سرم
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Biochemical analysis
    empty
    آنالیز بیوشیمیایی
    #10
    empty
    BDI questionnaire
    empty
    پرسشنامه افسردگی بک
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Likert scale
    empty
    طیف لیکرت
    #11
    empty
    Pittsburgh Sleep Quality Index (PSQI)
    empty
    پرسشنامه کیفیت خواب پیتزبورگ (PSQI)
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Likert scale
    empty
    طیف لیکرت
    #12
    empty
    The Council on Nutrition Appetite Questionnaire (CNAQ)
    empty
    پرسشنامه اشتها
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Likert scale
    empty
    طیف لیکرت
    #13
    empty
    Body composition
    empty
    ترکیب بدن
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Body analyzer
    empty
    دستگاه بادی آنالیزور
    #14
    empty
    Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, abdominal / hip ratio)
    empty
    اندازه های آنتروپومتری (قد، وزن، شاخص توده بدنی، دور کمر، دور باسن، نسبت دور شکم به دور باسن)
    empty
    at the beginning and end of 8-weeks intervention period
    empty
    ابتدا و انتهای هشت هفته مداخله
    empty
    Body analyzer
    empty
    دستگاه بادی آنالیزور
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Research Associate, School of Health
    Full name of responsible person - Persian: معاونت پژوهشی دانشکده بهداشت
    Street address - English: School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
    Street address - Persian: بلوار شهدای گمنام، دانشگاه علوم پزشکی شهید صدوقی یزد، دانشکده بهداشت
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8915173160
    Phone: +98 35 3820 9100
    Fax:
    Email: sphealth@ssu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Amir Hoshangh Mehrparvar
    Full name of responsible person - Persian: دکتر امیر هوشنگ مهر پرور
    Street address - English: School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
    Street address - Persian: بلوار شهدای گمنام، دانشگاه علوم پزشکی شهید صدوقی یزد، دانشکده بهداشت
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8915173160
    Phone: +98 35 3149 2239
    Fax:
    Email: azadehnajarzadeh@gmail.com
    Web page address:

Protocol summary

Study aim
Determining the effect of licorice extract on sex hormone binding testosterone and globulin (SHBG) in patients with polycystic ovary syndrome (PCOS) with overweight or obesity
Design
randomized double blind controlled clinical trial, parallel group
Settings and conduct
Of the obese women referring to the Imam Ali Clinic in Yazd, 72 people will be selected and randomly divided into two groups. The participants and investigator will not be aware of the drugs and placebo. The amount of sex hormones will be measured before and after of the intervention. Intervention is parallel and is performed in 8 weeks.
Participants/Inclusion and exclusion criteria
1) Age 18-45 years 2) BMI 25-35 3) Polycystic ovary syndrome according to Rotterdam criteria 1) Blood pressure equal or more than 90/140 mmHg 2) Cardiovascular diseases with regular medication 3) Liver, kidney and thyroid disorders, diabetes 4) Smoking 5) Taking multi vitamin-mineral supplements 6) Antioxidant and herbal treatments during the previous 3 months 7) Pregnancy and lactation 8) Consumption of licorice more than 300 gr per week 9) hereditary adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia and thyroid dysfunction (hypothyroidism) or androgen-secreting tumors 10) history of allergy to licorice or any of its compounds
Intervention groups
Intervention group: capsule containing 500 mg licorice extract three times daily Control group: Placebo capsule containing Corn starch three times daily
Main outcome variables
Serum testosterone level; Serum SHBG level; Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, waist to hip ratio); Body composition.

General information

Reason for update
Some essential data were omitted due to oversight during the initial registration, so this update has been made to complete them.
Acronym
IRCT registration information
IRCT registration number: IRCT20200922048802N2
Registration date: 2020-12-22, 1399/10/02
Registration timing: retrospective

Last update: 2025-03-12, 1403/12/22
Update count: 2
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Hadis Hooshmandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
hadis.july.1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-29, 1399/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of licorice extract on testosterone and Sex hormone binding globulin (SHBG), LH, FSH, Insulin, FBS, LDL, HDL, TG, Cholesterol, sleep quality, depression, and appetite in participants with polycystic ovary syndrome (PCOS) and overweight / obesity.
Public title
Determination of the effect of licorice on Sex hormone, insulin and fasting blood sugar, blood lipids, depression, sleep quality and appetite in participants with polycystic ovary syndrome (PCOS) and overweight / obesity.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 45 BMI 25-35 kg/m2 Polycystic ovary syndrome based on Rotterdam criteria
Exclusion criteria:
Blood pressure equal or than 90/140 mmHg Cardiovascular diseases with regular drug use, liver, kidney and thyroid disorders, diabetes Taking multi vitamin-mineral supplements Smoking Antioxidant and herbal treatments during the last 3 months Pregnancy and lactation Consumption of licorice more than 300 grams per week Hyper androgenism includes hereditary adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and hypothyroidism or androgen-secreting tumors History of allergy to licorice or any of its components
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Simple Random unit: Individual Tool: Randomized Tables A balanced block method is used to allocate concealment so that the number of samples assigned to each of the groups is equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements of licorice and placebo in the same capsules in terms of size, color and shape Encodes A and B on supplements and placebo
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences Yazd
Street address
School of health, Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd., Alem Sq.
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.SSU.SPH.REC.1397.152

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

2

Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Serum testosterone level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
ELISA Kit

Secondary outcomes

1

Description
Serum SHBG level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
ELISA Kit

2

Description
Serum FSH level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
ELISA Kit

3

Description
Serum LH level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
ELISA Kit

4

Description
Serum insulin level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
ELISA Kit

5

Description
Serum FBS level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Biochemical analysis

6

Description
Serum LDL level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Biochemical analysis

7

Description
Serum HDL level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Biochemical analysis

8

Description
Serum TG level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Biochemical analysis

9

Description
Serum Cholesterol level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Biochemical analysis

10

Description
BDI questionnaire
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Likert scale

11

Description
Pittsburgh Sleep Quality Index (PSQI)
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Likert scale

12

Description
The Council on Nutrition Appetite Questionnaire (CNAQ)
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Likert scale

13

Description
Body composition
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Body analyzer

14

Description
Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, abdominal / hip ratio)
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Body analyzer

Intervention groups

1

Description
People in this group will recieve three 500 mg capsules of licorice daily for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: People in this group will recieve three 500 mg capsules of placebo daily for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali clinic
Full name of responsible person
Hadis Hooshmandi
Street address
Navab Safavi Blvd.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3630 1700
Email
hadis.july.1994@gmail.com

2

Recruitment center
Name of recruitment center
Yazd University of Medical Sciences
Full name of responsible person
Hadis Hooshmandi
Street address
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
hadis.july.1994@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amir Hoshangh Mehrparvar
Street address
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2239
Email
azadehnajarzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Hadis Hooshmandi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
hadis.july.1994@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadehnajarzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hadis Hooshmandi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
hadis.july.1994@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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