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.
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
Acronym
IRCT registration information
IRCT registration number:IRCT20200922048802N2
Registration date:2020-12-22, 1399/10/02
Registration timing:retrospective
Last update:2020-12-22, 1399/10/02
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) in participants with polycystic ovary syndrome (PCOS) and overweight / obesity.
Public title
Determination of the effect of licorice on Sex hormone 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
2
Description
Serum SHBG level
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
ELISA Kit
3
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
4
Description
Body composition
Timepoint
at the beginning and end of 8-weeks intervention period
Method of measurement
Body analyzer
Secondary outcomes
empty
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
Research Associate, School of Health
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
sphealth@ssu.ac.ir
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