Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Ovarian Cysts

Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Natriuretic Agents

Reproductive Control Agents

Flavonoid

Metformin

Drospirenone

Ethinyl Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Combined

Contraceptive Agents, Female

Hesperidin

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)

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)

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

Daflon; two film coated tablets 500 mg daily

Daflon

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

Combined oral contraceptive

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).

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

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

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

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

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

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

Ain Shams University

Assistant lecturer

Herbal and Botanical

Hormones

Follicle Stimulating Hormone

Flax

Three different quantities of flax seed powder were intervened to the subjects. One group was given 15 grams of flax seed a day. Second group was given 20 grams and third group was given 25 grams off lax seed a day.

Intervention/ Dietary Supplement:

Flax seed powder

Three different quantities of flax seed powder were intervened to the subjects. One group was given 15 grams of flax seed a day. Second group was given 20 grams and third group was given 25 grams off lax seed a day.

Other Name: intervention

The controlled group was given no intervention. No intervention was done to this group.

Three different quantities of white flour were intervened to the subjects. One group was given 15 grams of white flour a day. Second group was given 20 grams and third group was given 25 grams of white flour a day.

Three different quantities of flax seed powder were intervened to the subjects. One group was given 15 grams of flax seed a day. Second group was given 20 grams and third group was given 25 grams off lax seed a day.

flaxseed powder

Khalid Mahmood, MPhill

The study was conducted to determine the therapeutic role of flax seed for Poly cystic ovary syndrome. A sample of 100 subjects were collected. The subjects were from various age group ranging from 18 to 45 years. Subjects showing the signs, symptoms, biochemical, and clinical parameters of the diseases were included in the study. Three different quantities of flax seed were introduced to the subjects for 90 days.

Objectives:

1. To assess the nutritional status of Poly cystic Ovary Syndrome patients
2. To determine the therapeutic role of flax seed for PCOS patients

Material and method: The level of follicle stimulating hormone, leutinizing hormone, sex hormone binding globulin, serum prolactin, ultrasound were analyzed. To determine the side effects of the flax seed, the liver-enzymatic, lipid profile, and renal tests were conducted.

Material and methods

Study Population:

The data were collected from the Allied Hospital. All Females of ages 18 to 45 years, having PCOS attending the OPD of Allied Hospital was taken as the study population. Efficacy trials were conducted on the patients of PCOS, including females of age 18-45 years. They were divided into different groups (as per no. of selected treatments along with the control). Ten subjects left the study and were replaced. The project was approved by the ethical review committee.The feeding study was conducted with the cooperation of Allied Hospital. The study protocol was discussed with medical professionals and finalized after through technical suggestions.

Selection of subjects and Study Design

The patients were assorted randomly into four groups, 25 in each, namely control (T0),

A total 100 female subjects were included in the study as under A) Control: To: 25 B) Experimental groups (PCOS): 75

1. T1: 25
2. T2: 25
3. T3: 25

Inclusion Criteria:

All females of age 18 to 45 having PCOS

Women showing the presence of two out of three features (Oligo- or anovulation, hyper-androgenism, or poly cystic ovaries (Ovarian volume \>10cc, 12 or more peripherally located follicles 2-9 mm in diameter or hypo-echoic enlarged ovaries with hyper-echoic central stroma in USG). Patients on Metformin (used for insulin resistance)

Exclusion Criteria:

* Females under 18 and above 45 years of age
* Those on any other medical therapy
* Pregnant and lactating women
* Those with a history of allergy to flax seed
* Women on anti-platelet and fibrinolytic drugs
* Women showing signs of PCOS but showing normal ovaries on ultrasound

Study Design

It was literature review based intervention study. The selected population for intervention purposes was studied twice, i.e. before and after the intervention of the selected nutraceutical. The same subjects were studied once again after one month of stopping the intake of selected nutraceutical. The change in results has confirmed the effects of the intervention.

This has been divided into four phases.

1. Phase-1:Assessment of the nutritional Status in PCOS
2. Phase -2:Development of nutraceutical (flaxseed sachets)
3. Phase -3:Intervention to study the effect of selected nutraceutical
4. Phase-4:Blood Analysis

   The procedure adopted in each of the above phases is explained as follows:

   Phase-1: Assessment of the nutritional status of selected patients

   This was done in Allied Hospital, patients attending OPD of gynecology ward was assessed for nutritional status. Following parameters were studied for this purpose
   * Family History
   * Medical history
   * Physical signs (thyroid gland, height, weight, skin, hair, breasts, belly, and BMI)
   * Menstrual cycle detail (menarche, frequency, duration, and severity)
   * History of dysmenorrhea
   * Ferriman-Gall way scoring for hirsutism
   * Marital status, parity, and difficulty in conception

   Phase -2: Development of Nutraceutical (flaxseed sachets)

   Procurement of raw materials Preparation of flax seed powder Preparation of flax seed sachets

   Phase-3: Intervention

   An acceptable number of human volunteers were selected keeping in view all ethical considerations. (25 in each group)
   1. Control group (To)
   2. Flaxseed (5 g) xTTS = 15 g/day (T1)
   3. Flaxseed (6.6 g) x TTS = 20 g/day (T2)
   4. Flaxseed (8.3 g) xTTS = 25 g/day (T3)

   The flaxseed powder from the selected treatments was given daily for a period of 12 weeks. The dietary history of the subjects was monitored with the help of a Food Diary on a weekly basis. Education/counselling were provided to the patients for necessary compliance with the restricted diet for PCOS.

   Phase-4: Blood Analysis and Ultrasound

   After three months of intervention blood tests: follicle stimulating hormone (FSH), Luteinizing hormone (LH) thyroid stimulating hormone (TSH), serum prolactin, and ultrasound will be repeated.

   Biochemical assays

   Follicles stimulating hormone

   The blood sample was taken to determine the quantitative level of serum follicles stimulating hormone (FSH) in patients fed with flaxseed powder by following the Immuno-enzymatic calorimetric method (ELISA).

   Luteinizing hormone

   The blood sample was taken to determine the quantitative level of serum luteinizing hormone (LH) in patients fed with flaxseed powder by following the Immuno-enzymatic calorimetric method.

   Sex hormone binding globulin

   The serum sex hormone binding globulin hormone (SHBG) in patients fed with flaxseed powder was determined by following the Rosner's method.

   Prolactin

   The serum sex prolactin level in patients fed with flaxseed powder was determined by following the radio-immunological method.

   Thyroid stimulating hormone

   The thyroid stimulating hormone (TSH) level in patients fed with flaxseed powder was performed to determine the thyroid gland functioning by following the third-generation non-isotopic method.

   Liver Function Test

   Alkaline Phosphatase (ALP)

   The activity of alanine phosphatase in the plasma was determined by using enzyme-linked immune-sorbent assay kit method.

   Aspartate Aminotransferase (AST)

   The activity alanine transferase in the plasma was determined by using di-nitrophenyl hydrazine (DNPH) method using Sigma kits 59-50 and 58-50 under the conditions.

   Alanine Aminotransferase (ALT)

   The activity alanine aminotransferase in the plasma was determined by using enzyme-linked immune-sorbent assay kit method.

   Lipid Profile

   Low-density lipoprotein (LDL)

   Serum low-density lipoprotein (LDL) was estimated by following the protocol of Vinson.

   High-density lipoprotein (HDL)

   The high-density lipoprotein (HDL) was assessed by HDL-Cholesterol precipitation.

   Triglyceride

   The triglyceride in the collected serum was determined by liquid triglyceride (GPO-PAP) method.

   Renal Function Tests

   Urea

   The flax seed fed patients were diagnosed with urea content by GLDH method with the help of commercial kit.

   Creatinine

   The blood creatinine of the patients fed on flax seed powder was determined by the Jaffe method using creatinine commercial kit.

   Follicles present in ovaries

   Ultrasound of the ovaries was carried out to check the number of follicles present in the ovaries.

   Size of the ovaries

   The size of the ovaries of patients fed with flax seed powder was also checked in ultrasound.

   Fasting blood glucose level

   The blood sample was taken to check the fasting blood glucose level. The sample was taken eight hours after eating. Fasting blood glucose level as determined by glucose dye oxido-reductase mediator reaction which is specific for glucose by glucometer Accuchek active.

   Research instruments
   1. Questionnaire: For screening/nutritional assessment of PCOS patients
   2. Hormonal analysis: Follicle stimulating hormone (FSH), luteinizing hormone (LH) thyroid stimulating hormone (TSH), Sex Hormone binding globulin (SHBG), and serum prolactin.
   3. Biochemical assay: ALP, ALT, AST, urea, Creatinine, Fasting blood glucose level, LDL, HDL, and triglyceride.

   Ethical Considerations:Written ethical approval was taken from the management of the concerned hospital and HOD of Gynecology department of the selected hospital. The consent was taken from the subjects after explaining the purpose of the study and after getting their consent for their menstrual cycle history, blood tests and ultrasound.

   Statistical analysis

   The data were subjected to statistical analysis by using the SPSS statistical package, analysis of variance (ANOVA) and least significant difference (LSD) was used to determine any significant difference among the treatments at p\<0.05.

Single-blinded trial, Intervention and placebo given

Therapeutic Role of Flax Seed for Poly Cystic Ovary Syndrome

The blood sample was taken to determine the quantitative level of serum follicles stimulating hormone (FSH) in patients fed with flaxseed powder by following the Immuno-enzymatic calorimetric method (ELISA).

The blood sample was taken to determine the quantitative level of serum luteinizing hormone (LH) in patients fed with flaxseed powder by following the Immuno-enzymatic calorimetric method (ELISA-ALPCO)

The serum sex hormone binding globulin hormone (SHBG) in patients fed with flaxseed powder was determined by following the Rosner's method.

The serum sex prolactin level in patients fed with flaxseed powder was determined by following the radio-immunological method.

The blood sample was taken to check the fasting blood glucose level. The sample was taken eight hours after eating. Fasting blood glucose level as determined by glucose dye oxido-reductase mediator reaction which is specific for glucose by glucometer Accuchek active

The thyroid stimulating hormone (TSH) level in patients fed with flaxseed powder was performed to determine the thyroid gland functioning by following the third-generation non-isotopic method.

Allied Hospital Faisalabad

Clinical Nutritionist

Anti-Infective Agents

Vildagliptin

Dipeptidyl-Peptidase IV Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Metformin Hydrochloride 850 mg oral tablet

Metformin Hydrochloride tablet

Vildagliptin 50 MG

ahmed hussein, phD

ahmed hussein

ahmed M. A, phD

Hanan elhanafy

ahmed hussein, PhD

Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial

October 6 University

LECTURER OF CLINICAL PHARMACY

Immune System Diseases

Nutritional and Metabolic Diseases

Hypersensitivity

Vitamin D Deficiency

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Bone Density Conservation Agents

Micronutrients

Anticoagulants

Other Dietary Supplements

Vitamins

Vitamin D

Cholecalciferol

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Trace Elements

Citrate

Vitamin D3

Calciferol

100 patients who are PCOS and resist CC will receive Vitamin D 10000 IU orally plus 150mg clomid orally for 3 months number and size of growing follicles will be monitored

Adding vitamin D to PCOS patients who are resistant to clomiphene regime for induction will or not improve the Clinical pregnancy rate and will or not increase chances of ovulation and pregnancy.

CLOMID is adrug used for ovulation induction

Clomid

rana nasr

alhassan khedr

effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate

Polycystic ovarian syndrome is the most common endocrine disorder . It is associated with chronic anovulation and infertility. The diagnosis is made by clinical and ancillary investigations revealing the presence of irregular menstrual cycles, an ovulation , Hyperandrgenemia , and the presence of polycystic ovaries (ovarian morphology as the presence of 12 or more follicles measuring 2-9 mm in diameter and an increased ovarian volume \>10 cm 3) ovulation can be induced with clomiphene citrate (CC), However, \~20%-25% of anovulatory women with PCOS do not respond to CC and are considered to be "clomiphene-resistant( clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days ) Vitamin D may serve as a key in preventing and attenuating the insulin resistance. Vitamin D plays a physiologic role in reproduction including ovarian follicular development and luteinisation, follicle-stimulating hormone sensitivity and progesterone production in human granulosa cells. It also affects glucose homeostasis .

In this trial 100 women with PCO disease that diagnosed by ROTTERDAM CRITERIA (must have any TWO of This findings: Hyperandrogenism, Oligomenorrhea, Polycystic ovaries). Who are taking clomiphene citrate for induction of ovulation and resistant to it, which means failure to ovulate with 3 months of usage of clomid at 150 mg/day for 5 days. They will recieve vitamin D (ossofortin®, Eva Pharma) orally 10000 IU twice weekly for other three months period with clomiphene citrate orally 150 mg/day for 5 days. Number and size of the growing follicles will be monitored before and after taking vitamin D by trans-vaginal ultrasound at day11-14 of the cycle till day 21 to detect effect of vitamin D in ovulation rate.

Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate

Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate

Number of ovulated follicles by trans vaginal ultra sound signs of ovulation

Pregnancy test positive by quantititave see beta HCG level

Measure the endometrium thickness by transvaginal ultrasound

rana alaaeldin aly ibrahim nasr

Clinical gynecology professor

Fenugreek seed meal

Fenugreek

Fenugreek seeds extract 500 mg

Dr Amrita Sarkari Jaipuriar, MS

Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels. The genetically determined cause of the PCOS includes disturbed levels of insulin and androgens. Standardized fenugreek seed extract (Furocyst) contains compounds such as saponins \& flavonoids which act on the insulin and indirectly helps to regulate the androgen levels in the body.

Polycystic ovary syndrome is considered as clinical and public health consequence involving increase in number of cysts in women at reproductive age. These cysts are under-developed sacs in which eggs are developed. In PCOS, these sacs are unable to release an egg which means ovulation doesn't take place.

The estimated 5-10% prevalence of PCOS is reported in women of reproductive age. A study from Spain also reported that 28.3% prevalence rate of PCOS is among 113 overweight or obese women who were referred to an endocrinology clinic for weight loss. This data was compared with a previously reported prevalence of 6.5% which suggests that the prevalence of PCOS might be markedly increasing with obesity.

PCOS impacts significantly on various hormonal cycles. With PCOS, luteinizing hormone (LH) levels become higher than follicle stimulating hormone (FSH) levels. Because of this increase in LH levels, the LH surge does not take place and ovulation doesn't carry out which results in irregular menstrual cycle. The irregular menstrual period produces oligomenorrhea (few menstrual periods) or amenorrhea (no menstrual periods) and infertility due to irregular or lack of ovulation. PCOS also produces high levels of masculinizing hormones with symptoms of acne and hirsutism, hypermenorrhea involving heavy and prolonged menstrual periods and androgenic alopecia (increase hair thinning and diffused hair loss). The other metabolic syndromes associated with PCOS are increased risk of type 2 diabetes, high cholesterol levels and obesity.

These complications arise because of the genetically determined cause of the PCOS i.e. hyper- secretion of androgens from the ovary which favours excess luteinizing hormone (LH) secretion and insulin resistance. However, insulin resistance with or without a genetic mutation may be the initiator, followed by hyper-androgenism. Thus, insulin resistance is an important contributing factor to abnormal steroidogenesis in PCOS because hyper-insulinemia stimulates the pathway of insulin like growth factor-I (IGF-I) in theca cells of the ovary by cross-reacting with the receptors of IGF. Stimulation of the ovarian theca cells increases the production of androgens (eg, testosterone, androstenedione) which in turn, blocks the down-regulation of androgens by LH surge and leads to the hyper-androgenic environment in the ovary. Because of a decreased level of FSH relative to LH, the ovarian granulosa cells cannot aromatize the androgens to estrogens, which lead to decreased estrogen levels and results in anovulation.

Treatments for PCOS are chosen based on woman's symptoms, age and future pregnancy plans which may include birth control pills to regulate menstruation, insulin-sensitizing medications, ovulation induction to treat infertility, androgen-blocking medications, topical anti-hair-growth medications, etc.

Standardized fenugreek (Trigonella foenum graecum) seed extract (Furocyst) plays an important role in the management of PCOS. It improves glucose-tolerance and insulin-sensitivity, thereby promoting weight loss and moderation of androgen levels in the blood. Standardized fenugreek seeds extract contains a group of furostanolic saponins, derived from fenugreek seeds by an innovative process. It contains rich variety of saponins and flavonoids which have been known to lower the blood lipid levels and play valuable role in improving insulin sensitivity. Standardized fenugreek seeds extract is a dual insulin-sensitizer. In the presence of high fiber furostanolic saponins, cells become more sensitive to insulin \& an increase in number of insulin receptor sites occurs. These receptor sites are responsive to insulin to stimulate the cells ability to burn glucose. This decrease in insulin resistance helps in the management of PCOS.

Considering the beneficial effects of standardized fenugreek seed extract, present study was conducted to evaluate the efficacy of fenugreek seeds extract in patients with poly cystic ovary syndrome by assessing reduction in ovarian volume and decrease in the number of ovarian cysts.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Effects of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome	NCT06083935	Poly Cystic Ova...	Daflon Combined oral c... Metformin	18 Years - 40 Years	Ain Shams University
Therapeutic Role of Flax Seed for Poly Cystic Ovary Syndrome	NCT03713138	Poly Cystic Ova...	flaxseed powder	18 Years - 45 Years	Allied Hospital Faisalabad
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome	NCT06142656	Poly Cystic Ova...	Metformin Hydro... Vildagliptin 50...	18 Years - 50 Years	October 6 University
Evaluation of the Effects of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome	NCT06083935	Poly Cystic Ova...	Daflon Combined oral c... Metformin	18 Years - 40 Years	Ain Shams University
Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate	NCT04916925	Vitamin D Defic... Clomiphene Alle... Polycystic Ovar...	Vitamin D Clomid	18 Years - 40 Years	Ain Shams University
Therapeutic Role of Flax Seed for Poly Cystic Ovary Syndrome	NCT03713138	Poly Cystic Ova...	flaxseed powder	18 Years - 45 Years	Allied Hospital Faisalabad
Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate	NCT04916925	Vitamin D Defic... Clomiphene Alle... Polycystic Ovar...	Vitamin D Clomid	18 Years - 40 Years	Ain Shams University
Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome	NCT02789488	Poly Cystic Ova...	Fenugreek seeds...	18 Years - 45 Years	Chemical Resources

Spots Global Cancer Trial Database for poly cystic ovary syndrome