| CTRI Number |
CTRI/2020/11/029426 [Registered on: 27/11/2020] Trial Registered Prospectively |
| Last Modified On: |
07/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post marketing study to evaluate the safety and efficacy of Roopmantra face wash for skin problems |
|
Scientific Title of Study
|
A Single Centric, Open Label, Non Randomized Phase IV Post Marketing Surveillance Study to Measure
the Efficacy and Safety of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash on Subjects Suffering
from Acne, Face Scars, Pimples, Blemishes, Dull& Dry skin. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H R Yogeesh |
| Designation |
Consultant |
| Affiliation |
Akshatha Skin and Hair Care Centre |
| Address |
Akshatha Skin & Hair Care Centre
12th Main Road, Koramangala 4th Block,
Bengaluru-560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9845834908 |
| Fax |
|
| Email |
hryogesh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kimtata |
| Designation |
Scientific Medical Reviewer |
| Affiliation |
Divisa Herbal Care |
| Address |
Divisa Herbal Care
SCO 135-136, 2nd Floor, Sector 9C, Above CM Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India
Chandigarh
CHANDIGARH
160009
India |
| Phone |
9816333352 |
| Fax |
|
| Email |
vijaykimtata.vk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd |
| Address |
Xplora Clinical Research Services Pvt. Ltd
# 252, 13th Cross,
Wilson garden, Bangalore-560027,
Karnataka, India
Bangalore
KARNATAKA
560027
India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
|
Source of Monetary or Material Support
|
| Divisa Herbal Care SCO 135-136, 2nd Floor, Sector 9C, Above CM Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India |
|
|
Primary Sponsor
|
| Name |
Divisa Herbal Care |
| Address |
SCO 135-136, 2nd Floor, Sector 9C, Above CM Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr H R Yogeesh |
Akshatha Skin & Hair Care Centre |
12th Main Road, Koramangala 4th Block,
Bengaluru-560034
Bangalore
KARNATAKA |
9816333352
hryogesh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: Roop Mantra Cucumber Ayurvedic Medicinal Face Wash on Subjects Suffering from Acne, Face Scars, Pimples, Blemishes, Dull& Dry Skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Roop mantra cucumber ayurvedic medicinal face wash |
Take small quantity in your palm and mix it with little water twice daily, preferably morning and evening for 30 days. Massage gently over face & neck in circular motion. Rinse thoroughly with water. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Between 18-45 Years
2. Male and Female subjects with general physical good mental condition
3. Willingness to take part in study and able to attend all scheduled visits
4. Skin type with acne, facial scars, pimples, blemishes, dull & dry skin
|
|
| ExclusionCriteria |
| Details |
1. Pregnant , Breastfeeding , subjects undergone any surgery and else take taken part in any cosmetic clinical trial
2. Not willing to sign the ICF or give the consent
3. Mole, Tattoos or any kind of allergy on the skin due to external or internal factor
4. Any Kind of psoriasis, leucoderma disorder and skin surgery
5. Use of facial bleach, facial scrub, hair removal or any other product within 2 weeks prior to screening
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of Skin Recovery (Change from Baseline) over a period of 30 Days in the subjects who have undergone in topical application of Roop Mantra Cucumber Ayurvedic Medicinal Face wash.
2. Assessment of Skin Recovery and removal of scars from baseline over a period of 30 days
|
1. Assessment of Skin Recovery (Change from Baseline) over a period of 30 Days in the subjects who have undergone in topical application of Roop Mantra Cucumber Ayurvedic Medicinal Face wash.
2. Assessment of Skin Recovery and removal of scars from baseline over a period of 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self assessment questionnaire filled by subject shall be taken from baseline to final visit to show the change in skin type designed on any parameter |
At the end of 15 days and at th end of 30 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
Study has been designed to evaluate the efficacy of Roop Mantra Cucumber Ayurvedic Medicinal Face wash
in adult human subject in order to check the Safety and evaluate the benefits
of product Roop Mantra
Cucumber Ayurvedic Medicinal Face wash as per dermatological
parameters. The
Study is an open label, single armed, single centric, Non-randomized, Phase IV
Post marketing surveillance study on 120 subjects. There are three visits in the study. On screening
visit i.e., day 1, the subjects will be screened based on inclusion and
exclusion criteria. Eligible subjects will be enrolled into the study after
informed consent procedure. Eligible Subjects will be provided with the informed
consent document and will be briefed about all study related procedure in
detail. The site Investigator will explain the subject about all study related
process and the visit 2 – Day 15 and Visit 3 Day 30(Final Visit). All eligible
subjects will then be provided with Test Product – Roop Mantra Cucumber Ayurvedic Medicinal Face wash by
Investigator/study coordinator. In the presence of Investigator, the
instructions will be given to use the test product at home from Day 1 to Day 30
i.e., Take small quantity in your palm and mix it with little water twice daily, preferably morning and
evening.
Massage gently over face & neck in circular motion. Rinse thoroughly with
water.
A dermatological evaluation /assessment shall be
performed on baseline Day 0 and final visit- Day 30. A self- assessment
questionnaire shall be given to all eligible subjects on Baseline and final
visit. This is an open label, non-randomized study involving healthy volunteers
between age 18-45 years.
|