Comparison of Probiotics, Metformin and Their Combination Therapy in Improving Symptoms of Polycystic Ovarian Syndrome.̎- A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Luteinizing Hormone
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a common gynecological state worldwide characterized by numerous small cysts in the ovaries mainly due to the imbalance of endocrine hormones in premenopausal women. Metformin is long being used for different symptoms of PCOS along with other medication. This study involves the assessment of different parameters of PCOS.
详细描述
Polycystic ovary syndrome (PCOS) is a hormonal disorder affecting the women of reproductive age. It is a heterogeneous health condition that affects 1 in every 10 women of childbearing age. Women of all races and ethnicities are at risk for PCOS, but risk increases multiple folds if the BMI is greater than 30kg/m2. The common signs and symptoms, the women usually represent with are menstrual irregularities, hyperandrogenemia and multiple cysts in ovaries. The exact cause of PCOS is still unknown but genetic and obesity is considered to be the most common cause.
Metformin has been considered as the first line agent for the treatment of non-insulin dependent diabetes mellitus and up till now it has been used as a first line drug for PCOS. Despite its beneficial effects in PCOS it has several adverse effects. Moreover, patients usually seek two or more drugs along with metformin to relieve maximum symptoms of PCOS like for ovulation clomiphene citrate must be given etc. So there is a need of novel and comprehensive agent that can prove to be effective in improving maximum symptoms of this disease. Probiotics have received renewed attention in the 21st century through research studies. World Health Organization's (WHO) 2001 defines probiotics as live micro-organisms that, when administered in adequate amounts, confer a health benefit on the host. In recent year it has shown tremendous promising effect in treatment of different diseases like diarrhea, gingivitis and obesity etc with negligible side effects.
In this context the investigators are going to evaluate and compare the effects of probiotics, metformin and their combination therapy in treatment of various symptoms of PCOS.60 newly diagnosed PCOS patient will be assigned in the open label randomized clinical trial. As mentioned above patients will be divided into three groups with 20 patients each. In group 1, the dosage of metformin will be 500mg B.D and 2 gm of probiotic sachet O.D, the second group will be given metformin 500mg B.D. and the third group will be 2mg of probiotics B.D. It would be a follow-up study that would be conducted in Gynecology OPD of Tertiary Care Hospital
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient will be included according to the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine sponsored a PCOS consensus criterion which says the presence of any two of the following three features must be present for the patient to be diagnosed as a case of PCOS:
- •Oligomenorrhea and/or amenorrhea (Oligomenorrhea>45 days or <8 cycles per year and amenorrhea >3 months in women with previous periodic menses) for a period of 6 months
- •Clinical and/or biochemical hyperandrogenemia, the presence of acne, hirsutism (FG score>8), and alopecia
- •Polycystic ovaries on sonography (>12 follicles in one or both ovaries, 2-9 mm in diameter and/or increased ovarian volume >10 mL).
排除标准
- •History of chronic diseases
- •Allergic to probiotic or metformin
- •Current or previous (within the last 6 months) use of chemotherapy or other drugs.
- •History of smoking
- •Individuals with autoimmune disease
- •Individuals with autoimmune disease.
研究组 & 干预措施
Metformin
Group no 1(26 patients) Metformin tablets at a dose of 500mg BD for 12 weeks
干预措施: Metformin (Drug)
Probiotic
Group no 2(26 patients): will be given probiotics alone at a dose of 180mg B.D for 12 weeks
干预措施: Probiotic Agent (Drug)
Metformin and Probiotic
Group no 3(26 patients): will be given metformin 500mg B.D and probiotics 180mgram O.D. for 12 week
干预措施: Probiotic Agent (Drug)
Metformin and Probiotic
Group no 3(26 patients): will be given metformin 500mg B.D and probiotics 180mgram O.D. for 12 week
干预措施: Metformin (Drug)
结局指标
主要结局
Luteinizing Hormone
时间窗: 12 weeks
LH The concentration of this endocrine hormones is determined will be obtained on day 2 or 3 of the normal menstruation cycle and at any time in women with amenorrhea. LH: 1.9 to 12.5 IU/L
Follicle-stimulating hormone
时间窗: 12 weeks
The concentration of this endocrine hormones is determined will be obtained on day 2 or 3 of the normal menstruation cycle and at any time in women with amenorrhea. LH: 4.5 to 21.5 IU/L
Change in cyst size on Ultrasonography
时间窗: 12 weeks
Ovary cyst size: The size of the cyst will be measured before the start and at the end of the study, considering 12 or more follicles in at least 1 ovary or both-measuring 2-9 mm in diameter-or a total ovarian volume greater than 10 cm3
INSULIN LEVELS
时间窗: 12 weeks
Fasting serum insulin: The sample is collected after fasting of 12 to 14 hours will be measured before and after intervention fasting insulin \< 25 mIU/L
Hormonal parameter:
时间窗: 12 weeks
Androgens: The concentration of these hormones will be evaluated at the baseline and at the end of treatment usually in the morning between 8:00 am to 9:00 am after overnight fasting Serum testosterone:15 and 70 ng/dL
Biochemical parameter:
时间窗: 12 weeks
Fasting serum glucose: The blood sample for FBS will be collected on day 2 or 3 of the menses. The blood samples will be taken before the start and at the end of the treatment. fasting glucose 80-100 mg/dl
Lipid
时间窗: 12 weeks
Lipid profile: 1. Total cholesterol 2. LDL 3. HDL 4. Triglyceride The serum lipid concentrations will be evaluated spectrophotometrically by means of commercial kits at baseline and at the end of the study Total cholesterol \< 200 Triglyceride: \<150 mg/dl HDL: \> 60mg/ dl LDL: \< 130mg /dl
LH and FSH ratio
时间窗: 12 weeks
LH:FSH The serum levels of FSH:LH ratio will be assessed before the start and at the end of the management on day 2 or 3 of the normal menses and at any time in women with amenorrhea. 1.5:1
次要结局
- Hirsutism(12 week)
- Change in Physical symptoms in PCOS(12 weeks)
- Acne(12 week)
- Menstruration(12 weeks)
研究者
Dr. Urooj Zafar
Principal Investigator
Ziauddin University