Clinical Study on Fish Collagen of Athos Collagen Pvt. Ltd for improving Skin Health
- Registration Number
- CTRI/2023/07/055042
- 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 age of 30 and 55 years ( both ages and all genders inclusive) looking to improve their skin health.
2. Subject with fine lines and wrinkles.
3. Subject who are willing to abstain from the use of herbal , allopathic or other nutritional Supplements (intervention) that are indicated at improving skin health.
4. Subjects who are rated as Grade 2-4 on the Wrinkle Severity Scale.
5. Subject who are willing to give informed consent for participation , able to comprehend and understand the responsibilities during screening and treatment period.
6. Subjects who are willing not to participate in any other clinical trail during participation in the current trail.
1. Subject with Known hypersensitivity to the ingredients of the investigational product
2. Subjects who are on Collagen supplements in any form.
3. Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product
4. Subjects who are on tropical treatments /regimens (prescribed, clinical or self) of retinol, vitamin C, bakuchiol, peeling treatments of AHA, BHA, Glycolic Acid or any combination thereof aimed at improvement skin texture, hyperpigmentation, pore size.
5. Subjects who have an active dermatological procedure done up to 3 months prior to screening.
6. Subjects who have an active infection, disease or disorder that will prevent 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 than 1 month before screening.
11. Any significant medical condition (eg., 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.
12. Subject who mentally unable to comphrened the responsibilities and adhere to the stipulations protocol.
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 Objective visual Assessment : m-Danielleâ??s Criteria : Reduction of greater than equal to 1 score from baseline. <br/ ><br>Clinical Grading of Skin : Reduction of greater than equal to 20% percentage in total score from baseline. <br/ ><br>Subjective Assessment of Cosmetic Effects : Total Score of lesser than equal to 15 by end of the study. <br/ ><br>IP Feedback Questionnaire : Total Score of greater than or equal to 15 by end of the study <br/ ><br>Timepoint: Objective visual Assessment : m-Danielleâ??s Criteria : Day 01, Day45, Day 90 <br/ ><br>Clinical Grading of Skin : Day 01, Day45, Day 90 <br/ ><br>Subjective Assessment of Cosmetic Effects : Day45, Day 90 <br/ ><br>IP Feedback Questionnarie : Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable