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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06043375
• Other study ID #: licorice-PCOS
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: Zurwa Maheen, MPhil
• Phone: +923214911042
• Email: zurwa.maheen05[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Females with diagnosed PCOS

Exclusion Criteria:

• Hypertension

• Cardiovascular diseases

• Pregnancy

• Any sort of allergy

• Skin problems

• Females without diagnosed PCOS

Related Conditions & MeSH terms

• Metabolic Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Veterinary and Animal Sciences, Lahore - Pakistan

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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