An Open Label, Multi-center, Prospective Clinical study to Evaluate Efficacy and Safety of Ayuvita Capsule in patients suffering from PCOS
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 2. Number of subjects achieving regular menstruation
研究概览
简要总结
It was an open label, multi-center, prospective, clinical study to evaluate efficacy and safety of Ayuvita Forte Capsule in patients suffering from PCOS. The study was conducted in 30 female subjects at two centers in India. Subjects were asked to consume 2 Ayuvita Forte Capsules twice daily orally after meals with water for 180 days. The primary objective of the study was to assess number of subjects achieving ovulation and number of subjects achieving regular menstruation. The secondary objectives of the study were to assess changes in serum testosterone, change in polycystic ovary as observed in the USG, changes LH, FSH, Progesterone, Estrogen, changes in HbA1c, Blood sugar F and PP and Serum Insulin, global assessment for overall change by subject and investigator at the end of study treatment, tolerability of study drug, adverse events and changes in laboratory parameters.
Summary of Results:
The results of the study conclude that Ayuvita Forte Capsules were found to be
effective in regularising menstrual cycles and resolve Poly Cystic
Ovarian condition as observed in Ultrasonography. Ayuvita capsules
also helped in achieving ovulation and has the potential to treat
infertility. Ayuvita capsules were found to be safe without causing any
adverse effects even on long term consumption of 6 months. Further
randomised comparative clinical study with larger sample size will help
to establish and validate the results of the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Subjects diagnosed with PCOS by ppresence of two of the of the three Rotterdam criteria: Oligomenorrhea, anovulation; Hyperandrogenism; and the observation of polycystic ovaries by USG of the Lower Abdomen and Pelvis.
- •2.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.
排除标准
- •Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion (as diagnosed by USG lower abdomen and pelvis).
- •Subjects having clinical and/or biochemical signs of severe hyperandronism
- •Subjects having systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, Hirsutism, Addison’s disease and/or Cushing disease.
- •Subjects with one year of history of child birth
- •History of genitor-urinary surgery, and/or other major medical or surgical diseases; which can affect or related with study outcomes.
- •Nursing, pregnant or lactating women.
- •Use of corticosteroids or hormones or hormonal drugs within last 1 months of screening visit.
- •Use of any other investigational drug within 1 month prior to screening visit.
- •Patient having known hypersensitivity to any ingredient of the study drug.
- •Pregnant and Lactating females.
- •Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.
结局指标
主要结局
2. Number of subjects achieving regular menstruation
时间窗: day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180
1. Number of subjects achieving ovulation.
时间窗: day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180
次要结局
- 1.Changes in Testosterone.(2.Change in polycystic ovary as observed in the USG.)