A Prospective Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of She Care Juice, in women diagnosed with Polycystic Ovarian Disease (PCOD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Change in the proportion of participants achieving regular menstrual cycles 21-35 days or documented ovulation.
研究概览
简要总结
This is a Prospective Open-Label, Single-Arm study with 30 Female participants in the age of 18-45 years to Evaluate the Efficacy and Safety of She Care Juice, in women diagnosed with Polycystic Ovarian Disease. The primary objectives are to evaluate the effect of She Care Juice on menstrual cycle regularity, hirsutism, and key hormonal parameters (LH, FSH, Testosterone) over a 90-day treatment period. Secondary objectives include assessing changes in metabolic markers, anthropometric measurements, acne, and psychological well-being, along with comprehensive safety monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Females aged 18 to 45 years, fulfilling at least 2 of following 3 criteria diagnosis of PCOS.
- •2.History of irregular menstrual cycles e.g., cycle length varying by more than 7 days, or cycles less than 21 days or more than 35 days for at least the past 3 to 6 months, potentially attributed to hormonal imbalance.
- •3.BMI between 18.5 and 38 kg per m2 inclusive 4.LH and FSH ratio more than 1 will be enrolled in the study.
- •5.Willing and able to provide written informed consent and comply with study procedures.
- •6.No use of anti-diabetic or anti-obesity medications for at least 3 months prior to screening.
- •7.Willing to come for follow up visits for evaluation 8.No significant medical or surgical diseases at the time of screening.
排除标准
- •1.Pregnancy, planning pregnancy during the study period or lactation.
- •2.Use of hormonal contraceptives or hormone replacement therapy within the last 3 months.
- •3.Diagnosed with severe endocrine disorders e.g., uncontrolled thyroid disease, Cushing syndrome or significant organic pelvic pathology e.g., large fibroids, endometriosis requiring immediate intervention.
- •4.Known allergy or hypersensitivity to any ingredient in She Care Juice.
- •5.Use of other treatments pharmacological or herbal known to affect menstrual cycles or hormonal balance within the last month.
- •6.Significant systemic, immunological, cardiovascular, hepatic, renal or gastrointestinal disorders.
- •7.Participation in another clinical trial within the last 90 days.
- •8.Any condition that in the opinion of the investigator would jeopardize the safety of the participant or the integrity of the study.
结局指标
主要结局
1.Change in the proportion of participants achieving regular menstrual cycles 21-35 days or documented ovulation.
时间窗: 1.Screening, Day 30, Day 60, Day 90. | 2.Screening, Day 90. | 3.Screening, Day 60, Day 90.
2.Mean change in modified Ferriman–Gallwey FG Score.
时间窗: 1.Screening, Day 30, Day 60, Day 90. | 2.Screening, Day 90. | 3.Screening, Day 60, Day 90.
3.Mean change in serum LH, FSH, LH and FSH ratio, and Total Testosterone levels.
时间窗: 1.Screening, Day 30, Day 60, Day 90. | 2.Screening, Day 90. | 3.Screening, Day 60, Day 90.
次要结局
- 1.Mean change in the IGA score for acne.(2.Mean change in Weight and BMI.)
研究者
Dr Sanjay Mishra
Rumedic Hospital