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

• ClinicalTrials.gov Identifier: NCT06043375
• Recruitment Status: Not yet recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Information provided by (Responsible Party): Sanaullah Iqbal, University of Veterinary and Animal Sciences, Lahore - Pakistan

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome; Polycystic Ovary Syndrome	Dietary Supplement: Licorice Root Powder Capsule	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Effect of Licorice Root Powder on Parameters of Metabolic Syndrome Related to Polycystic Ovary Syndrome
• Estimated Study Start Date: November 2023
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: March 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 49 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: women of reproductive age (15-49 years)
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Females with diagnosed PCOS

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Zurwa Maheen, MPhil; +923214911042; zurwa.maheen05@gmail.com

Contact: Sanaullah Iqbal, PhD; +923338981489; sanaullah.iqbal@uvas.edu.pk

Sponsors and Collaborators

University of Veterinary and Animal Sciences, Lahore - Pakistan

Investigators

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

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Sanaullah Iqbal, professor, University of Veterinary and Animal Sciences, Lahore - Pakistan
• ClinicalTrials.gov Identifier: NCT06043375
• Other Study ID Numbers: licorice-PCOS
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sanaullah Iqbal, University of Veterinary and Animal Sciences, Lahore - Pakistan:

Licorice; Metabolic Syndrome; Polycystic Ovary Syndrome; Licorice Root Powder

Additional relevant MeSH terms:

Polycystic Ovary Syndrome; Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases