search
Back to results

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

Primary Purpose

Metabolic Syndrome, Polycystic Ovary Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Licorice Root Powder Capsule
Sponsored by
University of Veterinary and Animal Sciences, Lahore - Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Licorice, Metabolic Syndrome, Polycystic Ovary Syndrome, Licorice Root Powder

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Licorice Root Powder Capsule

    Control Group

    Arm Description

    PCOS diagnosed patients in this group will receive licorice root powder capsules, once per day for 12 weeks.

    PCOS diagnosed patients in this group will not receive licorice root powder capsules or any treatment for 12 weeks.

    Outcomes

    Primary Outcome Measures

    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 in fasting blood glucose levels
    Fasting blood glucose levels will be measured using glucometer at 8-10 hours of fasting.
    Change in fasting blood pressure levels
    Fasting blood pressure levels will be measured using sphygmomanometer at 8-10 hours of fasting.
    Change in HDL and triglycerides levels
    HDL and triglycerides levels will be measured by taking blood sample and running tests in laboratory.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 12, 2023
    Last Updated
    September 12, 2023
    Sponsor
    University of Veterinary and Animal Sciences, Lahore - Pakistan
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06043375
    Brief Title
    Evaluation of Licorice Root on Metabolic Syndrome in Polycystic Ovary Syndrome Females
    Official Title
    Effect of Licorice Root Powder on Parameters of Metabolic Syndrome Related to Polycystic Ovary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Veterinary and Animal Sciences, Lahore - Pakistan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Polycystic Ovary Syndrome
    Keywords
    Licorice, Metabolic Syndrome, Polycystic Ovary Syndrome, Licorice Root Powder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Licorice Root Powder Capsule
    Arm Type
    Experimental
    Arm Description
    PCOS diagnosed patients in this group will receive licorice root powder capsules, once per day for 12 weeks.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    PCOS diagnosed patients in this group will not receive licorice root powder capsules or any treatment for 12 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Licorice Root Powder Capsule
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in abdominal obesity measurement at week 12
    Description
    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).
    Time Frame
    Change from baseline measurement at 3 months
    Title
    Change in fasting blood glucose levels
    Description
    Fasting blood glucose levels will be measured using glucometer at 8-10 hours of fasting.
    Time Frame
    Change from baseline fasting levels at 3 months
    Title
    Change in fasting blood pressure levels
    Description
    Fasting blood pressure levels will be measured using sphygmomanometer at 8-10 hours of fasting.
    Time Frame
    Change from baseline fasting levels at 3 months
    Title
    Change in HDL and triglycerides levels
    Description
    HDL and triglycerides levels will be measured by taking blood sample and running tests in laboratory.
    Time Frame
    Change from baseline levels at 3 months
    Secondary Outcome Measure Information:
    Title
    Change in stress levels
    Description
    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.
    Time Frame
    Change from baseline test scores at 3 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    women of reproductive age (15-49 years)
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females with diagnosed PCOS Exclusion Criteria: Hypertension Cardiovascular diseases Pregnancy Any sort of allergy Skin problems Females without diagnosed PCOS
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zurwa Maheen, MPhil
    Phone
    +923214911042
    Email
    zurwa.maheen05@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sanaullah Iqbal, PhD
    Phone
    +923338981489
    Email
    sanaullah.iqbal@uvas.edu.pk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sanaullah Iqbal, PhD
    Organizational Affiliation
    University of Veterinary and Animal Sciences, Lahore, Punjab, Pakistan.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31549221
    Citation
    Wang H, Ruan X, Li Y, Cheng J, Mueck AO. Oxidative stress indicators in Chinese women with PCOS and correlation with features of metabolic syndrome and dependency on lipid patterns. Arch Gynecol Obstet. 2019 Nov;300(5):1413-1421. doi: 10.1007/s00404-019-05305-7. Epub 2019 Sep 23.
    Results Reference
    background
    PubMed Identifier
    33409094
    Citation
    Anjum S, Askari S, Riaz M, Basit A. Clinical Presentation and Frequency of Metabolic Syndrome in Women With Polycystic Ovary Syndrome: An Experience From a Tertiary Care Hospital in Pakistan. Cureus. 2020 Dec 2;12(12):e11860. doi: 10.7759/cureus.11860.
    Results Reference
    background
    PubMed Identifier
    32931592
    Citation
    Maffazioli GDN, Lopes CP, Heinrich-Oliveira V, Lobo RA, Hayashida SAY, Soares JM Jr, Maciel GAR, Baracat EC. Prevalence of metabolic disturbances among women with polycystic ovary syndrome in different regions of Brazil. Int J Gynaecol Obstet. 2020 Dec;151(3):383-391. doi: 10.1002/ijgo.13374. Epub 2020 Oct 12.
    Results Reference
    background
    PubMed Identifier
    33134799
    Citation
    Shamsi M, Nejati V, Najafi G, Pour SK. Protective effects of licorice extract on ovarian morphology, oocyte maturation, and embryo development in PCOS-induced mice: An experimental study. Int J Reprod Biomed. 2020 Oct 13;18(10):865-876. doi: 10.18502/ijrm.v13i10.7771. eCollection 2020 Oct.
    Results Reference
    background
    PubMed Identifier
    32845813
    Citation
    de Medeiros SF, de Medeiros MAS, Barbosa BB, Yamamoto MMW. The Role of Visceral Adiposity Index as Predictor of Metabolic Syndrome in Obese and Nonobese Women with Polycystic Ovary Syndrome. Metab Syndr Relat Disord. 2021 Feb;19(1):18-25. doi: 10.1089/met.2020.0045. Epub 2020 Aug 25.
    Results Reference
    background
    PubMed Identifier
    35227470
    Citation
    Zhang Y, Xu Y, Zhang L, Chen Y, Wu T, Liu R, Sui W, Zhu Q, Zhang M. Licorice extract ameliorates hyperglycemia through reshaping gut microbiota structure and inhibiting TLR4/NF-kappaB signaling pathway in type 2 diabetic mice. Food Res Int. 2022 Mar;153:110945. doi: 10.1016/j.foodres.2022.110945. Epub 2022 Jan 10.
    Results Reference
    background
    PubMed Identifier
    37115805
    Citation
    Yang JP, Ullah A, Su YN, Otoo A, Adu-Gyamfi EA, Feng Q, Wang YX, Wang MJ, Ding YB. Glycyrrhizin ameliorates impaired glucose metabolism and ovarian dysfunction in a polycystic ovary syndrome mouse model. Biol Reprod. 2023 Jul 11;109(1):83-96. doi: 10.1093/biolre/ioad048.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs