Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Navroop- DS in patients suffering from Oligomenorrhea.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- •Change in the SGA Score (0-3) [Time frame 0-90 days] calculated as Abdominal Cramp, Headache, Vaginal discharge, Bloating, Irritability, Mood swings.
研究概览
简要总结
This is a phase PMCF single-arm, open label trial to evaluate the efficacy of Navroop- DS Syrup and Tablet when administered up to 90 days to the females suffering from Oligomenorrhea from age 18 years to 45 years of age.The trial subjects will be enrolled at 1 investigative site in India with approximately 40 patients who meet the trial inclusion and Exclusion criteria.
Subjects will be on study for up to 90 days.
Screening and Baseline: Day 1
Physical Follow-up: Day 30
Physical Follow-up: Day 60
End Visit: Day 90
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females from 18 to 45 years of age.
- •Females suffering from Oligomenorrhea.
- •If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
- •Females that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
- •Females willing to avoid participation in any other interventional clinical trial for the duration of the study.
排除标准
- •Females that are pregnant, breast feeding, or planning to get pregnant during the study.
- •Females that have participated in any other interventional clinical trial in the previous 90 days.
- •Females with known sensitivity to any of the constituents of the investigational product.
结局指标
主要结局
•Change in the SGA Score (0-3) [Time frame 0-90 days] calculated as Abdominal Cramp, Headache, Vaginal discharge, Bloating, Irritability, Mood swings.
时间窗: [Time frame 0-90 days]
Efficacy:
时间窗: [Time frame 0-90 days]
•Change in the LH range within time frame 0-90 days.
时间窗: [Time frame 0-90 days]
•Change in the FSH range within time frame 0-90 days.
时间窗: [Time frame 0-90 days]
•Change in the LH/FSH Ratio range within time frame 0-90 days.
时间窗: [Time frame 0-90 days]
Safety:
时间窗: [Time frame 0-90 days]
•Adverse Events
时间窗: [Time frame 0-90 days]
Tolerability of Navroop-DS syrup and tablet in treatment of Oligomenorrhea.
时间窗: [Time frame 0-90 days]
次要结局
- •Improvement in Quality of Life(SF-36)([Time frame 0-90 days])