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

NCT06043375 | Completed DMC

• 1 other identifier: licorice-PCOS
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Polycystic Ovary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Change in stress levels

  Change from baseline test scores at 3 months

Study Arms (2)

Licorice Root Powder Capsule

EXPERIMENTAL

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

Dietary Supplement: Licorice Root Powder Capsule

Control Group

NO INTERVENTION

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

Interventions

Licorice Root Powder Capsule DIETARY_SUPPLEMENT

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.

Licorice Root Powder Capsule

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: women of reproductive age (15-49 years)
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females with diagnosed PCOS

You may not qualify if:

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

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

University of Veterinary and Animal Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 31549221 BACKGROUND

• 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.

  PMID: 33409094 BACKGROUND

• 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.

  PMID: 32931592 BACKGROUND

• 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.

  PMID: 33134799 BACKGROUND

• 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.

  PMID: 32845813 BACKGROUND

• 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.

  PMID: 35227470 BACKGROUND

• 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.

  PMID: 37115805 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and 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

Study Officials

• Sanaullah Iqbal, PhD

  University of Veterinary and Animal Sciences, Lahore, Punjab, Pakistan.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: February 1, 2024
• Primary Completion: March 10, 2024
• Study Completion: June 5, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)