| CTRI Number |
CTRI/2020/11/029427 [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 Roop Mantra Cream 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 Ayurvedic Medicinal Cream on Subjects Suffering from Acne,
Face Scars, Pimples, Blemishes, Dull & Dry Skin |
| Trial Acronym |
RMAMC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H R Yogesh |
| 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 |
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 |
# 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Roop Mantra Ayurvedic Medicinal cream |
Apply a small amount of this product (an amount equal to the surface area of the tip of a finger)& message gently over cleansed face twice a day, preferably morning and evening for 60 days |
|
|
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 complexion.
|
|
| 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 Ocular Disorder and Ocular 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 60 Days in the Subjects who have undergone in topical application of Roop Mantra Ayurvedic Medicinal Cream.
2. Assessment of Skin recovery and removal of Scars from baseline over a period of 60 days.
|
1. Assessment of Skin Recovery (Change from Baseline) over a period of 60 Days in the Subjects who have undergone in topical application of Roop Mantra Ayurvedic Medicinal Cream.
2. Assessment of Skin recovery and removal of Scars from baseline over a period of 60 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. 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 30 days and at the end of 60 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 Ayurvedic Medicinal Cream in adult human subject in order to
check the Safety and evaluate the benefits of product Roop Mantra Ayurvedic
Medicinal Cream 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 briefed
with the study procedure and a member from the study team will explain the
subject about all study related procedure. An informed consent form will given
to all subject at screening visit containing all study information in it.
Eligible subjects will be enrolled into the study after informed consent
procedure. The site Investigator will explain the subject about all study
related process and the visit 2 – Day 30 and Visit 3 Day 60(Final Visit). All eligible subjects will be then provided
with Test Product – Roop Mantra Ayurvedic Medicinal Cream by Investigator/study
team member. In the presence of Investigator, the instructions will be given to
use the test product at home from Day 1 to Day 60 i.e. Apply a small amount of
this product (an amount equal to the surface area of the tip of a finger)&
message gently over cleansed face twice a day, preferably morning and evening
for 60 days.
A
dermatological evaluation /assessment shall be performed on Baseline Day 0 and
final visit Day 60. 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.
|