Protocol summary
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Study aim
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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
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Design
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randomized double blind controlled clinical trial, parallel group
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
11)The study did not include patients taking estrogen or progesterone, but those who had previously been treated with metformin continued to receive it. Moreover, the patients were not included if they had taken new drugs within two month before and during the study.
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Intervention groups
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Intervention: capsule containing 500 mg licorice extract three times daily
Control: Placebo capsule containing Corn starch three times daily
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Main outcome variables
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Serum testosterone level; Serum SHBG level; Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, waist to hip ratio); Body composition.
General information
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Reason for update
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Some essential data were omitted due to oversight during the initial registration, so this update has been made to complete them.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200922048802N2
Registration date:
2020-12-22, 1399/10/02
Registration timing:
retrospective
Last update:
2025-08-25, 1404/06/03
Update count:
2
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Registration date
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2020-12-22, 1399/10/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-09-22, 1399/07/01
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Expected recruitment end date
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2020-11-29, 1399/09/09
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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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.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Supplements of licorice and placebo in the same capsules in terms of size, color and shape Encodes A and B on supplements and placebo
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-02-18, 1397/11/29
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Ethics committee reference number
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IR.SSU.SPH.REC.1397.152
Health conditions studied
1
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Description of health condition studied
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Polycystic ovarian syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
2
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Description of health condition studied
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Overweight and obesity
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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Serum testosterone level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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ELISA Kit
Secondary outcomes
1
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Description
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Serum SHBG level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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ELISA Kit
2
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Description
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Serum FSH level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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ELISA Kit
3
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Description
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Serum LH level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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ELISA Kit
4
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Description
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Serum insulin level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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ELISA Kit
5
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Description
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Serum FBS level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Biochemical analysis
6
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Description
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Serum LDL level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Biochemical analysis
7
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Description
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Serum HDL level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Biochemical analysis
8
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Description
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Serum TG level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Biochemical analysis
9
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Description
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Serum Cholesterol level
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Biochemical analysis
10
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Description
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BDI questionnaire
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Likert scale
11
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Description
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Pittsburgh Sleep Quality Index (PSQI)
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Likert scale
12
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Description
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The Council on Nutrition Appetite Questionnaire (CNAQ)
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Likert scale
13
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Description
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Body composition
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Body analyzer
14
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Description
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Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, abdominal / hip ratio)
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Timepoint
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at the beginning and end of 8-weeks intervention period
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Method of measurement
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Body analyzer
Intervention groups
1
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Description
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People in this group will recieve three 500 mg capsules of licorice daily for 8 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: People in this group will recieve three 500 mg capsules of placebo daily for 8 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available