| CTRI Number |
CTRI/2022/07/044250 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Essen Merry Glow - Supplement for Skin, Hair and Nail Health |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/NUT/071/20 Version 01 03May22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Essen Fooddies India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Essen Fooddies India Pvt Ltd |
| Address |
KINFRA Park, Kakkancherry
Malappuram 673635,
Kerala, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai 600024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Department of General/Family Medicine
Room no 7. #180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Clinically healthy adults looking to improve their skin, nail and hair health. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Essen Merry Glow |
Route of Administration : Oral
Formulation : Liquid
Dose : 35.71g (1 packet) in 150 ml cold water 45-60 minutes before bedtime
Dosage : OD for 3 months
|
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Skin Health : Clinical Grading : Decrease of 50% in Total Score from Baseline
2. Hair Health : m-Hair Health Assessment : Decrease of 50% in Total Score from Baseline
3. Nail Health : Brittle Nail Assessment : Increase of 20% of the Total Score from Baseline
4. Patient’s Global Impression Scale : Score of 4 at end of the study
|
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
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2022 |
| Date of Study Completion (India) |
20/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 cold
water 45-60 minutes before bedtime
Dosage : OD for 3 months
Subject Population : 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.
Treatment Arms : One. Non Comparative Single Arm
Study
Number of Subjects : 35 Subjects
Efficacy Assessments:
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
Safety Assessments:
1. Clinical Safety : CBC, Serum Biochemistry
2. Monitoring of Adverse Events
Background
of the Study : The skin is an important organ of the human body and acts as
a barrier against external environmental factors such as sunlight exposition,
temperature, dust, bacterial attack, etc. Collagen is one of the most important
support structures found naturally in skin, helping to maintain elasticity and
suppleness. Our body contains fibroblasts which are responsible for producing
collagen, 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 also
damage collagen production in the body. Research has suggested that taking
collagen supplements can stimulate your body’s ability to produce collagen. The
most significant decrease in collagen production begins during menopause, which
is why taking a collagen supplement sooner rather than later may be beneficial.
Purpose of the Study : Marine collagen is a pure form
of hypoallergenic protein produced from fish scales. The fish skins are
hydrolysed by an acid and a food-grade enzyme to yield the marine collagen
peptides. These have a lower molecular weight which is easier to digest and
absorb than other types of collagen. Marine collagen is rich in type I
collagen which can help minimize fine lines and wrinkles as well as improving
skin elasticity and hydration. Type I collagen is also suggested to help
rebuild muscles, increase bone strength and aid joint health.
Essen
Merry Glow is a drink by Essen
Fooddies India Pvt. Ltd. with collagen which can improve the skin, hair and
nail health in adults
|