Effect of Myo-Inositol and D-Chiro-Inositol Combination Therapy on Improvement in Menstrual Irregularities and Biochemical Characteristics in Patients With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in Menstrual Irregularity
研究概览
简要总结
The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and hormone levels in women with polycystic ovarian syndrome (PCOS).
The main questions this study aims to answer are:
- Does treatment with myo-inositol and D-chiro-inositol improve menstrual regularity in women with PCOS compared with placebo?
- Does the treatment improve biochemical characteristics, including luteinizing hormone (LH), follicle-stimulating hormone (FSH), and testosterone levels, compared with placebo?
Researchers will compare a combination of myo-inositol and D-chiro-inositol with a placebo (folic acid alone) to determine whether the combination therapy is more effective in treating PCOS-related menstrual and hormonal abnormalities.
Participants will:
- Be randomly assigned to receive either a myo-inositol and D-chiro-inositol combination tablet (40:1 ratio) or placebo twice daily for 3 months.
- Have blood samples collected before starting treatment and after 3 months to measure LH, FSH, and testosterone levels.
- Attend monthly follow-up visits during the 3-month treatment period to assess changes in menstrual regularity and monitor their progress.
The study will enroll 60 women aged 18-45 years with PCOS at the Department of Obstetrics and Gynecology, Nishtar Hospital Multan. The results may help determine whether myo-inositol and D-chiro-inositol combination therapy is an effective treatment for improving menstrual function and hormonal abnormalities in women with PCOS.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed case of PCOS, ≥ 6-months
排除标准
- •Hyperprolactinemia, hypothyroidism, adrenal hyperplasia or Cushing's syndrome (on history & medical record review)
研究组 & 干预措施
Myo-Inositol and D-Chiro-Inositol Combination Therapy
Participants will receive a combination tablet containing myo-inositol, D-chiro-inositol, and folic acid
干预措施: Myo-Inositol and D-Chiro-Inositol Combination Therapy (Drug)
Placebo
Participants will receive folic acid tablets orally
干预措施: placebo (folic acid) (Drug)
结局指标
主要结局
Improvement in Menstrual Irregularity
时间窗: From enrollment to the end of treatment at 3 months
The proportion of participants achieving improvement in menstrual irregularity after treatment. Improvement is defined as restoration of a regular menstrual cycle with an average cycle length of 24-32 days and menstrual blood loss of 21-50 mL per cycle. Menstrual irregularity includes amenorrhea, oligomenorrhea, or menorrhagia assessed through participant menstrual history.
次要结局
未报告次要终点
研究者
Dr. Amna Razzaq
Principal Investigator
Nishtar Medical University
