Clinical Study on Fish Collagen from Athos Collagen Pvt. Ltd. for Improving on Hair and Nail Health
- Registration Number
- CTRI/2023/07/055135
- Lead Sponsor
- Athos Collagen Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Clinically healthy adult subjects between the ages of 21 and 55 years (both ages and all genders inclusive) looking to improve their Hair and Nail Health.
2. Subjects who have scored greater than or equal 15 in Hair and Nail Health Screening Questionnaire.
3. Subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements (interventional) that are indicated at improving 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 to the ingredients of the investigational product
2. Subjects who are on collagens supplements in any form.
3. Subjects who are vegetarians/ vegans who object to consumption of animal origin investigational product.
4. Subjects who had an active dermatological procedure done up to 3 months prior to screening
5. Subjects who have skin condition/ scarring that prevent proper examination or evaluation of study criteria.
6. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study
7. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
8. Subjects on remission from cancer of any type less than 5 years at the time of screening.
9. Subjects who are planning a pregnancy and/or currently breastfeeding.
10. Subjects who have participated in a clinical study less than1 month before screening.
11. 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., planed relocation) that the investigator felt would interfere with study evaluations and study participation.
12. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocols.
13. 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. m-Subjective Self Assessment: Hair Health : Total Score of less than or equal to 18 by end of the study. <br/ ><br>2. m-Subjective Self Assessment : Nail Health: Total Score of less than or equal to 9 by end of the study. <br/ ><br>3. Nail Fracturing Evaluation: Reduction by greater than or equal to 20 percentage by end of the study <br/ ><br>4. IP Fracturing Questionnaire: total score of greater than or equal to 15 by end of the study. <br/ ><br>Timepoint: 1. m-Subjective Self Assessment: Hair Health : Day 45, Day 90 <br/ ><br>2. m-Subjective Self Assessment : Nail Health: Day 45, Day 90 <br/ ><br>3. Nail Fracturing Evaluation: Day 45, Day 90 <br/ ><br>4. IP Feedback Questionnaire: Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable