An open label, Clinical study to Evaluate the anti-ageing and anti-inflammatory activity of Miror Revive tablets
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
- 4. change in C-Reactive Protein (CRP)
研究概览
简要总结
Participants will receive the investigational product for a period of 30 days, with follow-up assessments conducted on Day 1 and Day 30.
Enrollment will occur following confirmation of the subject’s age-ing diagnosis.
At screening (Day 1), subjects will be enrolled based on the study’s inclusion and exclusion criteria.
· Skin Firmness (Cutometer Assessment): (Day 0 & Day 30)
· Skin Hydration (Corneometer): (Day 0 & Day 30)
· TEWL (Tewameter): (Day 0 & Day 30)
· CRP (C-Reactive Protein): (Day 0 & Day 30)
· ESR (Erythrocyte Sedimentation Rate): (Day 0 & Day 30)
· SGA(Subject Global Assessment)- Gut/Metabolism, Energy, Confusion, Poor memory, Difficulty in Concentrating, Fine Lines/Wrinkles, Age Spots, Dryness
· CASP-19(Control, Autonomy, Self-realization, and Pleasure-19)
Volunteers-40, Females from 30-55 years of age
Subjects will be on study for up to 30 days.
Screening and Baseline: Day 1
Telephonic Follow-up: Day 15 EOT- Day 30
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females from 30-55 years of age.
- •Females having Ageing (Fine Lines, Wrinkles, Age spots etc.) 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
4. change in C-Reactive Protein (CRP)
时间窗: At T0 and T30Days
5. Erythrocyte Sedimentation Rate (ESR)
时间窗: At T0 and T30Days
1. change in skin hydration
时间窗: At T0 and T30Days
2. change in TEWL
时间窗: At T0 and T30Days
3. Change in Skin firmness
时间窗: At T0 and T30Days
次要结局
- 1. SGA(2. Change in CASP-19(Control, Autonomy, Self-realization, and Pleasure-19))
研究者
Dr Robin chugh
CCFT Laboratories