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

September 12, 2023 updated by: Sanaullah Iqbal, University of Veterinary and Animal Sciences, Lahore - Pakistan

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females with diagnosed PCOS

Exclusion Criteria:

  • Hypertension
  • Cardiovascular diseases
  • Pregnancy
  • Any sort of allergy
  • Skin problems
  • Females without diagnosed PCOS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Licorice Root Powder Capsule
PCOS diagnosed patients in this group will receive licorice root powder capsules, once per day for 12 weeks.
Dietary supplement: Licorice Root Powder Capsule
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.
No Intervention: Control Group
PCOS diagnosed patients in this group will not receive licorice root powder capsules or any treatment for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in abdominal obesity measurement at week 12
Time Frame: Change from baseline measurement at 3 months
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
Time Frame: Change from baseline fasting levels at 3 months
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
Time Frame: Change from baseline fasting levels at 3 months
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
Time Frame: Change from baseline levels at 3 months
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
Time Frame: Change from baseline test scores at 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Investigators

  • Principal Investigator: Sanaullah Iqbal, PhD, University of Veterinary and animal Sciences, Lahore, Punjab, Pakistan.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • licorice-PCOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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