Clinical Study on Fish Collagen from Athos Collagen Pvt. Ltd. for Improving on Hair and Nail Health

Phase 3

Completed

Conditions: 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.

Registration Number: CTRI/2023/07/055135

Lead Sponsor: Athos Collagen Private Limited

Brief Summary: **Study Design :** An Open Label, Prospective,Non-Randomised, Non- Comparative, Single Arm Clinical Study

**Indication :** Hair and Nail Health.

**Investigational Product :**FiColla from Athos Collagen Pvt. Ltd.

**Comparator:** Not Applicable. Non comparativesingle arm study.

**Dose/Dosage Dose :** 4 gram ineach sachet mixed with 100 ml lukewarm water **Dosage :** Once a day for 90 days

**Subject Population :** Clinically healthy adult subjectsbetween the ages of 21 and 55 years (both ages and all genders inclusive)looking to improve their hair and nail health.

**Number of Subjects :** 30 Evaluable Subjects

**Treatment Arms :** I

**Treatment Duration :** 90 Days (3 Months)

**Efficacy Assessments 1.m-Subjective Self Assessment: Hair Health :** Day 45, Day 90 **2.m-Subjective Self Assessment: Nail Health :** Day 45, Day 90 **3.Nail Fracture Evaluation :** Day 45, Day 90 **4.IP Feedback Questionnaire :** Day 90

**Safety Assessments** 1.Clinical Safety :CBC, Serum Biochemistry: Day 01, Day 90 2.Monitoring adverse events : Day 01, Day 90

**Background of the study:** Hair and nail have psychological andsocial importance throughout the ages in framing the personality and generalappearance of an individual. Healthy hair and nails are functionally andcosmetically Important for both men and women in daily life. Marine collagen is rich in type 1 collagenwhich can help in improving hair and nail health.

**Purpose of the Study :** Marine collagen showed to beeffective in cosmetics due to its antioxidant properties. The collagen metabolitesattracting fibroblast that generate the synthesis of new collagen. Therebymarine collagen supplements improve the hair and nail health. This clinical study is done to evaluate the safety and effectiveness of FiCollaof Athos Collagen Private Limited as a nutritional supplement for hair and nailhealth of adults.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

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.
Subjects who have scored greater than or equal 15 in Hair and Nail Health Screening Questionnaire.
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.
Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

Exclusion Criteria

Subjects with known hypersensitivity to the ingredients of the investigational product 2.
Subjects who are on collagens supplements in any form.
Subjects who are vegetarians/ vegans who object to consumption of animal origin investigational product.
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.
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.
Subjects who are planning a pregnancy and/or currently breastfeeding.
Subjects who have participated in a clinical study less than1 month before screening.
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.
Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocols.
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.	1. m-Subjective Self Assessment: Hair Health : Day 45, Day 90 \| 2. m-Subjective Self Assessment : Nail Health: Day 45, Day 90 \| 3. Nail Fracturing Evaluation: Day 45, Day 90 \| 4. IP Feedback Questionnaire: Day 90
3. Nail Fracturing Evaluation: Reduction by greater than or equal to 20 percentage by end of the study	1. m-Subjective Self Assessment: Hair Health : Day 45, Day 90 \| 2. m-Subjective Self Assessment : Nail Health: Day 45, Day 90 \| 3. Nail Fracturing Evaluation: Day 45, Day 90 \| 4. IP Feedback Questionnaire: Day 90
2. m-Subjective Self Assessment : Nail Health: Total Score of less than or equal to 9 by end of the study.	1. m-Subjective Self Assessment: Hair Health : Day 45, Day 90 \| 2. m-Subjective Self Assessment : Nail Health: Day 45, Day 90 \| 3. Nail Fracturing Evaluation: Day 45, Day 90 \| 4. IP Feedback Questionnaire: Day 90
4. IP Fracturing Questionnaire: total score of greater than or equal to 15 by end of the study.	1. m-Subjective Self Assessment: Hair Health : Day 45, Day 90 \| 2. m-Subjective Self Assessment : Nail Health: Day 45, Day 90 \| 3. Nail Fracturing Evaluation: Day 45, Day 90 \| 4. IP Feedback Questionnaire: Day 90

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1): Raam Clinic
🇮🇳
Chennai, TAMIL NADU, India
Raam Clinic
🇮🇳Chennai, TAMIL NADU, India
Dr VT Sriraam
Principal investigator
9840909155
md@auroushealthcare.com