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

• Sponsor: Ain Shams University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06083935
• Collaborator: (none)
• Enrollment: 120
• Arms: 3
• Anticipated Duration (Months): 13

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Poly Cystic Ovary Syndrome	Drug: Daflon; Drug: Combined oral contraceptive; Drug: Metformin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Effect of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metformin + Combined oral contraceptive 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; Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily; Drug: Metformin; Glucophage ® 500 tablets twice daily
Experimental: Diosmin /Hesperidin + Combined oral contraceptive 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; Daflon; two film coated tablets 500 mg daily; Drug: Combined oral contraceptive; Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily
Active Comparator: Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination 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; Daflon; two film coated tablets 500 mg daily; Drug: Combined oral contraceptive; Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily; Drug: Metformin; Glucophage ® 500 tablets twice daily

Outcome Measures

Primary Outcome Measures

1. Improvement of the inflammation [4 months]

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

2. Improvement of glycemic index [4 months]

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

Secondary Outcome Measures

1. Improvement of PCOS status levels [4 months]

   Improvement of PCOS status by improvement of signs and symptoms, hormone levels

2. Improvement of patient's quality of life [4 months]

   Improvement of patient's quality of life by using the women health questionnaire (WHQ)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 1-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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fatma Ahmed Tony, Assistant lecturer, Ain Shams University
• ClinicalTrials.gov Identifier: NCT06083935
• Other Study ID Numbers: REC#166
• First Posted: Oct 16, 2023
• Last Update Posted: Oct 16, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Metformin; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined

Study Results

No Results Posted as of Oct 16, 2023