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
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
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
NCT ID
NCT06043375
First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
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
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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
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Evaluation of Licorice Root on Metabolic Syndrome in Polycystic Ovary Syndrome Females
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