Evaluation of the Effects of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome

NCT06083935 | Unknown Phase 4 FDA Drug

• 1 other identifier: REC#166
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Polycystic ovary syndrome (PCOS) is one of the most prevalent disorders worldwide. Insulin resistance, inflammation and disturbance in sex hormone levels are the main contributing factors of this disease.The majority of studies addressing the status of chronic low-grade inflammation in PCOS have focused on the measurement of C-reactive protein (CRP) followed by stimulation of interleukin 6 (IL-6) and tumor necrosis factor (TNF-alpha). Daflon 500 mg tablets (containing 90% of diosmin and 10% of hesperidin) is used in patients to treat varicose veins, venous ulcers, hemorrhoids and lymphatic insufficiency. It has anti-diabetic, anti-inflammatory, microcirculatory, and antioxidant effects. So the aim of the work is to investigate the effect of Diosmin/Hesperidin in the management of PCOS through evaluation of Oxidative stress and inflammation, improvement of signs and symptoms through patients' follow-up, improvement of PCOS status by sonography and hormonal levels, measuring of anti-diabetic effect by measuring, fasting insulin, HOMA-IR and measuring the improvement of patient's quality of life by using the women health questionnaire (WHQ).

Conditions

Poly Cystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

• Improvement of the inflammation

  Improvement of PCOS status by improvement of the inflammatory markers (IL-6)

  4 months

• Improvement of glycemic index

  Improvement of glycemic index by measuring fasting Insulin, HOMA-IR

  4 months

Secondary Outcomes (2)

• Improvement of PCOS status levels

  4 months

• Improvement of patient's quality of life

  4 months

Study Arms (3)

Metformin + Combined oral contraceptive

ACTIVE COMPARATOR

Metformin (Glucophage ® 500 tablets twice daily)+ Combined oral contraceptive (standard therapy) (Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily)

Drug: Combined oral contraceptive; Drug: Metformin

Diosmin /Hesperidin + Combined oral contraceptive

EXPERIMENTAL

Diosmin /Hesperidin (Daflon two tablets 500 mg daily)+ Combined oral contraceptive((Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily)

Drug: Daflon; Drug: Combined oral contraceptive

Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination

ACTIVE COMPARATOR

Diosmin /Hesperidin (Daflon two tablets 500 mg daily) +Metformin (Glucophage ® 500 tablets twice daily) + Combined oral contraceptive combination (Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily

Drug: Daflon; Drug: Combined oral contraceptive; Drug: Metformin

Interventions

Daflon DRUG

Daflon; two film coated tablets 500 mg daily

Diosmin /Hesperidin + Combined oral contraceptive; Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination

Combined oral contraceptive DRUG

Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily

Diosmin /Hesperidin + Combined oral contraceptive; Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination; Metformin + Combined oral contraceptive

Metformin DRUG

Glucophage ® 500 tablets twice daily

Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination; Metformin + Combined oral contraceptive

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with confirmed diagnosis of PCOS aged in the range from18-40 (premenopausal adults) diagnosed with PCOS according to Rotterdam criteria by an expert gynecologist; (1) oligo-ovulation and/or anovulation (2) Clinical and biochemical hyperandrogenism and (3) polycystic ovaries on ultrasonography

You may not qualify if:

• Pregnant and nursing women 2-Menopause women 3-Diabetic patients 4-Adrenal hyperplasia 5-Adrenal Tumor 6-Thyroid dysfunction 7-Women on confounding medications which affect ovarian function

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Diosmin; Contraceptives, Oral, Combined; Metformin

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 16, 2023
• Study Start: November 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share