CTRI Number	CTRI/2018/12/016661 [Registered on: 13/12/2018] Trial Registered Retrospectively
Last Modified On:	07/12/2018
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug Ayurveda Other (Specify) [Treatment for skin cosmetic problems]
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	Clinical study of skin-beautifying effect of SkinCera supplementation.
Scientific Title of Study Modification(s)	A Prospective, Randomized, Single blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of SkinCera in improving skin health.
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr B N Satish  Address  Sri Kalabyraveshwara Swamy Ayurvedic Medical College and Hospital and Research Centre, No 10, Pipe Line Road, R P C Layout, Vijayanagar 2nd Stage, Bengaluru. No 10, Pipe Line Road, R P C Layout, Vijayanagar 2nd Stage Bangalore KARNATAKA 560104 India  Phone  7892914197   Fax     Email  drbnsatish@yahoo.com
Details Contact Person Scientific Query Modification(s)	Name  Dr B N Satish  Address  Sri Kalabyraveshwara Swamy Ayurvedic Medical College and Hospital and Research Centre, No 10, Pipe Line Road, R P C Layout, Vijayanagar 2nd Stage, Bengaluru. No 10, Pipe Line Road, R P C Layout, Vijayanagar 2nd Stage Bangalore KARNATAKA 560104 India  Phone  7892914197   Fax     Email  drbnsatish@yahoo.com
Details Contact Person Public Query Modification(s)	Name  Dr B N Satish  Address  Sri Kalabyraveshwara Swamy Ayurvedic Medical College and Hospital and Research Centre, No 10, Pipe Line Road, R P C Layout, Vijayanagar 2nd Stage, Bengaluru. No 10, Pipe Line Road, R P C Layout, Vijayanagar 2nd Stage Bangalore KARNATAKA 560104 India  Phone  7892914197   Fax     Email  drbnsatish@yahoo.com
Source of Monetary or Material Support	Sponsor
Primary Sponsor	Name  Vidya Herbs Pvt Ltd  Address  #30, 33rd Main, 16th cross J.P. Nagar 6th Phase Bangalore   Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr B N Satish  Sri Kalabyraveshwara Swamy Ayurvedic Medical College and Hospital and Research Centre  No 10, Pipe Line Road, R P C Layout, Vijayanagar 2nd Stage, Bengaluru Bangalore   7892914197 drbnsatish@yahoo.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee, Sri Kalabyraveswara Swamy Ayurvedic Medical College and Hospital and Research Centre  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Subjects with cosmetic problems related skin.
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  Placebo  Malto-Dextrin 50 mg twice daily before breakfast and dinner orally. Duration - 6 weeks  Intervention  SKINCERA  Gluco ceramide 50 mg twice daily before breakfast and before dinner orally. Duration of treatment - 6 weeks
Inclusion Criteria	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  Subject who is willing and is able to comply with all trial requirements. Subjects who have some signs and symptoms related to skin cosmetic appearance such as roughness, dryness, oily skin, itching, redness, acne marks, white heads and black heads. Subjects who have hyperpigmentation problems with skin darkening and wrinkle appearance Subjects with atopic dermatitis.
ExclusionCriteria	Details  Subjects with chronic disorders. Population containing children and geriatric individuals. Pregnant women and nursing mothers. Subjects who have the habit of smoking and drinking alcohol. Subjects who are undergoing other cosmetic treatment.
Method of Generating Random Sequence	Other
Method of Concealment	Pre-numbered or coded identical Containers
Blinding/Masking Modification(s)	Participant Blinded
Primary Outcome	Outcome  TimePoints  Efficacy of IP in improving skin health (mainly moisturising effect and reducing the wrinkles including atopic dermatitis).  Week 2, 4, 6 and follow up at week 8
Secondary Outcome	Outcome  TimePoints  Assessment of any untoward adverse events.  Week 2, 4, 6 and follow up at week 8
Target Sample Size	Total Sample Size="50" Sample Size from India="50"
Phase of Trial	Phase 3
Date of First Enrollment (India) Modification(s)	01/08/2017
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	Not Applicable
Brief Summary Modification(s)	A phase III  Prospective, Randomized, Single blind, Placebo Controlled Clinical Study to Evaluate the Efficacy of SkinCera in improving the skin health (Moisturizing effect and reducing the wrinkle formation, Redness, elasticity, hyperpigmentation, white heads and black heads, acne marks and atopic dermatitis) as well as to monitor any untoward side effects. A sample size of 50 will be used to statistically analyse the IP efficacy and safety. Duration of the study is approximately 6 to 8 months where as treatment duration is 6 weeks. The study is a single blind and single centre study. Initially the study was planned to be held as multicentric study, but since the required sample size could be recruited in one centre, it was changed to single centre. Also, the double blind was changed to single blind as subjects in the placebo arm complained of failure of the product in improvement of skin condition. The changes has been incorporated in the Protocol Amendment that was approved by Ethics Committee.