A SINGLE ARM CLINICAL STUDY TO ASSESS THE SAFETY AND EFFIACY OF ALVAS AYURVEDIC LIP BALM 1
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the safety of ayurvedic lip balm
研究概览
简要总结
The cosmetic industry is increasingly turning towards cosmeceuticals, which represent the fastest growing segment of the natural personal care market. Plant-based extracts have gained prominence in cosmetic formulations, as animal-derived ingredients are losing acceptance due to safety and ethical concerns.
With growing awareness, the public is showing strong preference for herbal and Ayurvedic formulations, valued for their superior qualities, minimal side effects, and holistic benefits. While many lip care products in the market are promoted as natural, organic, or herbal, most still contain synthetic bases, pigments, emulsifiers, and artificial fragrances, which reduce their authenticity and may cause adverse effects.
Among herbal cosmetics such as face washes, shampoos, and creams, Ayurvedic lip balms are gaining popularity as natural alternatives for dry, chapped, and discolored lips. The advantage of these formulations lies in their composition, derived entirely from herbs and natural oils, which provide nourishment, hydration, protection, and healing properties for delicate lip skin.
The present study is designed to formulate and evaluate an Ayurvedic lip balm that can effectively moisturize, protect, and restore the natural softness and color of lips. The study also aims to establish the efficacy and safety of this Ayurvedic formulation compared to conventional synthetic lip care products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects without any known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies.
- •Subjects willing to have a wash out of other cosmetic product three days before the study begin and willing abstain from any other cosmetic product on face.
- •Subjects willing to visit the site at specified frequencies for periodic evaluations.
排除标准
- •Known allergy to any ingredients of the product Subjects participating in any other similar clinical study or test panel within one month before the entry into the study.
- •Subjects receiving steroids or antihistamine medications for other conditions.
- •Subjects with a history of drug and/or alcohol abuse.
- •Presence of any active skin infection.
- •Pregnant or lactating women.
结局指标
主要结局
To evaluate the safety of ayurvedic lip balm
时间窗: 7 DAYS
次要结局
- To evaluate the efficacy of lip balm(7 DAYS)
研究者
Dr Shruthi K S
ALVAS AYURVEDA MEDICAL COLLEGE