An open Label, Clinical Study to Evaluate the Symptomatic Relief with Miror BLISS tablets in patients having Menopause and Peri-menopause
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Estrogen( Estradiol, Estrone, Estriol)
研究概览
简要总结
An Open Label, Single arm clinical study.
Each participant entering the trial will be assigned to a regimen of investigational product, and advised to take general precautions as needed.
**Participants will receive the investigational product for a period of 28 days, with follow-up assessments conducted on Day 1 and Day****28.**Enrollment will occur following confirmation of the subject’s Menopause and Perimenopause diagnosis At screening (Day 1), subjects will be enrolled based on the study’s inclusion and exclusion criteria.
The following assessments will be conducted on Day 1 and 28 day:
· Estrogen( Estradiol, Estrone, Estriol)
· SGA(Subject Global Assessment)
o Hot Flashes
o Night Sweats
o Mood Swings
o Disturbed sleep
o Dizziness
o Muscle Aches
o Breast tenderness
o Palpitation
· MENQOL
Subjects will be on study for up to 28 days. Screening and Baseline: Day 1, Telephonic Follow-up: Day 15, End Visit: Day 28
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Females from 35-55 years of age.
- •Females having Menopause and Peri-Menopause will be eligible for enrollment.
- •Subjects 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.
- •Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.
排除标准
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
- •Subjects that have participated in any other interventional clinical trial in the previous 90 days.
- •Subjects with known sensitivity to any of the constituents of the investigational product.
- •Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •Chronic illness which may influence the outcome of the study.
- •Pregnant/nursing mothers.
结局指标
主要结局
1. Estrogen( Estradiol, Estrone, Estriol)
时间窗: Time points: Day 1 and 28 day
2. SGA(Subject Global Assessment)
时间窗: Time points: Day 1 and 28 day
次要结局
- 1. MENQOL
研究者
Dr Shikha Sharma
CCFT Laboratories