| CTRI Number |
CTRI/2019/03/018233 [Registered on: 22/03/2019] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect 0f a herbal face gel on skin hydration. |
|
Scientific Title of Study
|
Clinical study to evaluate the effectiveness of a test face gel for moisturizing and enhancing skin health. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GG Gangadharan |
| Designation |
Director |
| Affiliation |
Ramaiah indic Specialty Ayurveda |
| Address |
A unit of Gokula Education foundation, New BEL Road, MSRIT post, Mattikere
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
vaidyaggganga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GG Gangadharan |
| Designation |
Director |
| Affiliation |
Ramaiah indic Specialty Ayurveda |
| Address |
A unit of Gokula Education foundation, New BEL Road, MSRIT post, Mattikere
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
vaidyaggganga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GG Gangadharan |
| Designation |
Director |
| Affiliation |
Ramaiah indic Specialty Ayurveda |
| Address |
A unit of Gokula Education foundation, New BEL Road, MSRIT post, Mattikere
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
vaidyaggganga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hindusthan Unilever limited, Unilever House,
B. D. Sawant Marg,
Chakala, Andheri (E),
Mumbai - 400 099. |
|
|
Primary Sponsor
|
| Name |
Ramaiah Indic SPecialty Ayurveda |
| Address |
A unit of gokula education foundation, New BEL Road, Mattikere, MSRIT post, Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Hindusthan Unilever limited |
Unilever House,
B. D. Sawant Marg,
Chakala, Andheri (E),
Mumbai - 400 099. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suprabha Hegde |
Ramaiah Indic specilaty Ayurveda restoration clinic |
1st floor,RBI LAYOUT, Kothnur Main Road, ABOVE VIJAYA BANK, JP Nagar 7th Phase, Bengaluru, 560078
Bangalore
KARNATAKA |
8722810753
drprabha2u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RISA Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with dry skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
test face gel |
Apply around 1gm of the gel all over the face, gently rubbing it in, till the gel gets absorbed. A demonstration of the procedure will be given at site. Subjects will apply the product twice daily with an interval of 8 hours between two applications |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female healthy volunteers, with age 18–45 years
2.Subjects willing and able to provide informed consent voluntarily
3. Subjects having normal to moderate dry skin as assessed on the 4-point scale given below
4.Willing to maintain the investigational product use throughout the study.
5.Subjects who have not undergone any skin therapy (eg. De-tan, etc.) in last 3 months
6.Subjects with no known allergy to any of the test ingredients
7.Subjects who are willing to refrain from using any skin care product for the face other than the investigational product, like, moisturizers, lotions and face creams, for the duration of the study
8.Subjects willing and able to comply with all trial requirements.
9.Laboratory workup within normal limits; including complete hemogram, glucose, blood urea nitrogen, creatinine, liver function test, lipid profile, thyroid-stimulating hormone, urine pregnancy test
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have skin diseases like psoriasis, atopic dermatitis , severe dry, self-approved acne etc. at the time of screening
2. Subject with chronic systemic illnesses or treatment that can affect skin health eg. Dialysis
3.Subjects on oral medications or suffering from chronic illness which will compromise the study
4.Subjects who have participated in a similar investigation in the past four weeks
5.Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the moisturization of the skin will be assessed by the senior Ayurveda clinician using a 4-point scale-overall dry skin score. |
At the end of 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A self-perceived skin health satisfaction questionnaire will also be administered to the subjects at baseline and at the end of the study. |
at the end of 30 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2019 |
| Date of Study Completion (India) |
08/06/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective open label
clinical study to assess the effectiveness of the herbal face gel in
moisturizing and enhancing skin health. Baseline history will be obtained in order to
determine the subject’s eligibility for enrolment in the study. The baseline
assessment will include personal data, a description of symptoms and details of
past medical history, history of possible exacerbating factor/s, etc.
A total of 50 subjects will be
recruited, of which data of at least 40 completed subjects will be used to draw
the result and the statistics. On recruitment, the case record proforma will be
completed with thorough examination for Ayurveda parameters including
Dashavidha pariksha. Prakriti will be assessed using the TNMC Questionnaire
during the recruitment as it would help to understand the effectiveness
specific to prakriti. Outcome assessments before, during and after the study
will be done by a senior Ayurveda clinician at RISA, who is not a part of the
research team.
Subjects will be given a
conditioning phase for 7 days at entry. Following this, they will be given the herbal
face gel and instructed to apply 1gm quantity of the gel all over the
face, gently rubbing it in, till the gel gets absorbed. The second application
will be done with a time gap of 8 hours. A demonstration of the procedure will
be given at site. Subjects will apply twice daily, for a period of 30days, with
a visit to RISA after 15 and 30days. Subjects will be asked to return the old
tubes at the final visit, in order to monitor their use. Subjects will not be
allowed to use any other cosmetic product, such as gel, cream, lotion, or milk
on the face, other than Lux soft touch soap as daily wash. Skin moisturization will be measured by
clinical assessment by a senior Ayurveda clinician at RISA, who is not a part
of the research team. Secondary changes will be assessed using a self-perceived
skin health satisfaction questionnaire. All the subjects will be given a small
diary to make a note of the product use so as to monitor the compliance. |