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
|
|
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
|
|
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
|
|
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. |