An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Essen Merry Glow†of Essen Fooddies India Pvt. Ltd as a Collagen Drink for Skin, Hair and Nail Health in Adults.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1. Skin Health : Clinical Grading : Decrease of 50% in Total Score from Baseline
研究概览
简要总结
Study Design : Open Label, Prospective, Non-Randomised,Non-Comparative, Single Arm Clinical Study
Indication : Supplement for Skin, Hair and Nail Health.
Investigational Product Details Name : Essen Merry Glow Route of Administration : Oral Formulation : Liquid Dose : 35.71g (1 packet) in 150 ml coldwater 45-60 minutes before bedtime Dosage : OD for 3 months
Subject Population : Clinicallyhealthy adults, between the ages of 30 and 65 years(both ages and all genders inclusive) looking to improve their skin, nail andhair health.
Treatment Arms : One. Non Comparative Single ArmStudy
Number of Subjects : 35 Subjects
Efficacy Assessments: 1. Skin Health : Clinical Grading : Day1, Day 45, Day 90 2. Hair Health : m-Hair Health Assessment : Day 1, Day 45, Day 90 3. Nail Health : Brittle Nail Assessment : Day 1, Day 45, Day 90 4. Patient’s Global Impression Scale : Day 90
Safety Assessments: 1. Clinical Safety : CBC, Serum Biochemistry 2. Monitoring of Adverse Events
Backgroundof the Study : The skin is an important organ of the human body and acts asa barrier against external environmental factors such as sunlight exposition,temperature, dust, bacterial attack, etc. Collagen is one of the most importantsupport structures found naturally in skin, helping to maintain elasticity andsuppleness. Our body contains fibroblasts which are responsible for producingcollagen, but as we age, the production rate starts to slow down. In fact,research has suggested that after the age of 20, a person produces about 1%less collagen each year. A poor diet, stress, smoking and sun damage can alsodamage collagen production in the body. Research has suggested that takingcollagen supplements can stimulate your body’s ability to produce collagen. Themost significant decrease in collagen production begins during menopause, whichis why taking a collagen supplement sooner rather than later may be beneficial.
Purpose of the Study : Marine collagen is a pure formof hypoallergenic protein produced from fish scales. The fish skins arehydrolysed by an acid and a food-grade enzyme to yield the marine collagenpeptides. These have a lower molecular weight which is easier to digest andabsorb than other types of collagen. Marine collagen is rich in type Icollagen which can help minimize fine lines and wrinkles as well as improvingskin elasticity and hydration. Type I collagen is also suggested to helprebuild muscles, increase bone strength and aid joint health.
EssenMerry Glow is a drink by EssenFooddies India Pvt. Ltd. with collagen which can improve the skin, hair andnail health in adults
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinically healthy adults, between the ages of 30 and 65 years (both ages and all genders inclusive) looking to improve their skin, nail and hair health.
- •2.Subjects with any skin type who along with fine lines and wrinkles must have any one of the following concerns.
- •i.Dry Hair ii.Dull Hair iii.Brittle and Thin Hair including hair breakage iv.Brittle Nails 3.Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving skin, hair and nail health.
- •4.Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
- •5.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1.Subjects with known hypersensitivity or ethical objection to the ingredients of the investigational product 2.Subjects who have no dermatological condition of the skin, nail or hair that impedes with basic physical examination or determination of efficacy of investigational product on the skin.
- •3.Subjects who on active treatment for skin, hair and/or nail conditions 4.Subjects who have nail biting habit.
- •5.Subjects on remission from cancer of any type less than 5 years at the time of screening 6.Subjects who are planning a pregnancy and/or currently breastfeeding.
- •7.Subjects who have participated in a clinical study less than 1 month before screening.
- •8.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •9.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •10.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
结局指标
主要结局
1. Skin Health : Clinical Grading : Decrease of 50% in Total Score from Baseline
时间窗: 1. Skin Health : Clinical Grading : Day 1, Day 45, Day 90 | 2. Hair Health : m-Hair Health Assessment : Day 1, Day 45, Day 90 | 3. Nail Health : Brittle Nail Assessment : Day 1, Day 45, Day 90 | 4. Patient’s Global Impression Scale : Day 90
4. Patient’s Global Impression Scale : Score of 4 at end of the study
时间窗: 1. Skin Health : Clinical Grading : Day 1, Day 45, Day 90 | 2. Hair Health : m-Hair Health Assessment : Day 1, Day 45, Day 90 | 3. Nail Health : Brittle Nail Assessment : Day 1, Day 45, Day 90 | 4. Patient’s Global Impression Scale : Day 90
2. Hair Health : m-Hair Health Assessment : Decrease of 50% in Total Score from Baseline
时间窗: 1. Skin Health : Clinical Grading : Day 1, Day 45, Day 90 | 2. Hair Health : m-Hair Health Assessment : Day 1, Day 45, Day 90 | 3. Nail Health : Brittle Nail Assessment : Day 1, Day 45, Day 90 | 4. Patient’s Global Impression Scale : Day 90
3. Nail Health : Brittle Nail Assessment : Increase of 20% of the Total Score from Baseline
时间窗: 1. Skin Health : Clinical Grading : Day 1, Day 45, Day 90 | 2. Hair Health : m-Hair Health Assessment : Day 1, Day 45, Day 90 | 3. Nail Health : Brittle Nail Assessment : Day 1, Day 45, Day 90 | 4. Patient’s Global Impression Scale : Day 90
次要结局
未报告次要终点