Evaluation of Licorice Root on Metabolic Syndrome in Polycystic Ovary Syndrome Females

Study Overview
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Brief Summary
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The goal of this study is to learn about the effect of licorice root powder on parameters of metabolic syndrome in those women diagnosed with PCOS with age range of 15-49 years of age. The study aims to answer the following questions: Will licorice root powder consumption will have an impact on parameters of metabolic syndrome which are HDL levels, triglycerides, fasting blood pressure and blood glucose levels and abdominal obesity related to PCOS. Will licorice help in lowering stress scores and improve quality of life. Females with diagnosed PCOS will be recruited in the study and will be randomly allotted to two groups. One group will be intervention group and second will be control group. Participants in intervention group will be given 1000mg of licorice root powder in form of capsules (1 per day). Control group will not take anything. For both groups, SF-12 health survey, and readings of lipid profile, fasting blood glucose and blood pressure and central obesity will be taken. Researcher will compare readings of both groups at baseline and after 3 months of intervention to assess the effect of licorice root powder.

Detailed Description
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Polycystic ovary syndrome (PCOS) is an endocrine disorder which is characterized by ovarian cyst, irregular menses and elevated androgen levels whereas metabolic syndrome (metS) includes presence of 3 out of 5 conditions which are abdominal obesity, high blood glucose levels, high blood pressure, high triglyceride levels and low HDL levels. Metabolic syndrome and polycystic ovary syndrome have a two-way relationship. The risk of development of metS in PCOS females is five-fold higher than non-PCOS females. If PCOS is not addressed timely then it can lead to infertility. Herbal treatments and ayurvedic medicine is thought to be effective in treating PCOS. A lot of data is available which shows positive results using herbs like cinnamon, aloevera etc but data on licorice root powder is limited. Licorice is one of the oldest herb and has anti-inflammatory, antidiabetic, antiobesity, hypolipidemic and so many other properties which makes it very useful herb. The objective of this study is to evaluate antidiabetic, hypolipidemic and anti-inflammatory properties of licorice root powder on metabolic syndrome related to PCOS. The study will also observe effect of licorice on stress levels using SF-12 questionnaire. The study will be conducted in seven steps. Step 1 is the preparation of licorice root powder capsules. Step 2 is recruitment of participants. Participants will be recruited from universities and hospitals after checking their ultrasound report or diagnosis of PCOS by doctor. Step 3 is dividing the participants into two groups which are control and intervention group based on randomization. Step 4 is conduction of baseline testing of both groups of abdominal obesity, TGL, HDL, BGL, BP and stress levels. Step 5 is administration of capsules for 3 months. Step 6 is post-interventional testing. Similar tests will be done as baseline testing. Step 7 is data analysis. Data will be analyzed using SPSS software and paired sample t test will be used for results interpretation.

Official Title
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Effect of Licorice Root Powder on Parameters of Metabolic Syndrome Related to Polycystic Ovary Syndrome

Conditions
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Metabolic Syndrome, Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: Licorice Root Powder Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females with diagnosed PCOS Exclusion Criteria: Hypertension Cardiovascular diseases Pregnancy Any sort of allergy Skin problems Females without diagnosed PCOS

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allotted to two groups. One group will receive licorice root powder capsules while the other group will not receive any treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Licorice Root Powder Capsule<br>PCOS diagnosed patients in this group will receive licorice root powder capsules, once per day for 12 weeks. | Dietary Supplement: Licorice Root Powder Capsule<br>* Fresh licorice root will be obtained from local market of Lahore. The root will be washed and dried at room temperature. Then it will be converted into powder using grinder. After sieving the ground powder, it will be filled in capsules. One capsule will contain 1000mg of powder. Participants in experimental group will be instructed to consume one capsule per day.<br>|
| No Intervention: Control Group<br>PCOS diagnosed patients in this group will not receive licorice root powder capsules or any treatment for 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal obesity measurement at week 12 | Abdominal obesity will be assessed using waist circumference measurements. An inches tape will be used to measure waist circumference (normal is less than 80 cm). | Change from baseline measurement at 3 months | 
| Change in fasting blood glucose levels | Fasting blood glucose levels will be measured using glucometer at 8-10 hours of fasting. | Change from baseline fasting levels at 3 months | 
| Change in fasting blood pressure levels | Fasting blood pressure levels will be measured using sphygmomanometer at 8-10 hours of fasting. | Change from baseline fasting levels at 3 months | 
| Change in HDL and triglycerides levels | HDL and triglycerides levels will be measured by taking blood sample and running tests in laboratory. | Change from baseline levels at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stress levels | A questionnaire will be used to assess stress levels. SF-12 Health Survey is a validated questionnaire used to assess patients reviews about their health and assessing stress levels using scores. It contains 12 questions. | Change from baseline test scores at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Licorice, Metabolic Syndrome, Polycystic Ovary Syndrome, Licorice Root Powder