Study on Essen Merry Glow - Supplement for Skin, Hair and Nail Health
- Registration Number
- CTRI/2022/07/044250
- Lead Sponsor
- Essen Fooddies India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Skin Health : Clinical Grading : Decrease of 50% in Total Score from Baseline <br/ ><br>2. Hair Health : m-Hair Health Assessment : Decrease of 50% in Total Score from Baseline <br/ ><br>3. Nail Health : Brittle Nail Assessment : Increase of 20% of the Total Score from Baseline <br/ ><br>4. Patientâ??s Global Impression Scale : Score of 4 at end of the study <br/ ><br>Timepoint: 1. Skin Health : Clinical Grading : Day 1, Day 45, Day 90 <br/ ><br>2. Hair Health : m-Hair Health Assessment : Day 1, Day 45, Day 90 <br/ ><br>3. Nail Health : Brittle Nail Assessment : Day 1, Day 45, Day 90 <br/ ><br>4. Patientâ??s Global Impression Scale : Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method oneTimepoint: None