A Clinical Study to Evaluate the Anti-Ageing Activity of Silphion Oral Collagen Powder on Healthy Human Volunteers
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Change in Melanin index by mexameter
研究概览
简要总结
To Check safety and efficacy of oral collagen
Total Volunteers: 50 participants
Dose:
-
25 volunteers will take 5 grams per day for 28 days.
-
25 volunteers will take 10 grams per day for 28 days
Measurements and images for the following:
-
Melanin index
-
Lightning index
3. Hydration
4. Elasticity
5. Wrinkles in the crow’s feet area
- Blemishes ( 3D images and evaluation by specialist)
7. Under-eye dark circles
It is a Randomized study design
Total Duration- 28 Days
Follow ups- Day0, Day28
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)（—）
入选标准
- •Gender: Non-pregnant, non-lactating female aged between 30 to 55 (Female:Male ratio to be 80:20) 2) Subjects willing to give written informed consent 3) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •1.Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •2.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •3.Volunteers Allergic to Fish.
- •4.Volunteers Taking long term medication.
- •5.Have participated in any interventional clinical trial in the previous 30 days.
- •6.Have a known sensitivity to any of the constituents of the test product including sensitivities to (mention some of active ingredient’s name) 7.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
- •8.Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
结局指标
主要结局
1. Change in Melanin index by mexameter
时间窗: At t0 and t28
2. Change in Hydration by cornemeter
时间窗: At t0 and t28
3. Change in Elasticity
时间窗: At t0 and t28
4. Change in water loss through skin by TEWL
时间窗: At t0 and t28
5. Change in Wrinkles and blemishes by Visio Scan
时间窗: At t0 and t28
6.Change in under eye dark circle
时间窗: At t0 and t28
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories